xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05991479</url>
    </required_header>
    <id_info>
      <org_study_id>286206</org_study_id>
      <nct_id>NCT05991479</nct_id>
    </id_info>
    <brief_title>Pilates Exercises on Muscle Strength and Balance After Healed Lower Limb Burns</brief_title>
    <official_title>Effect of Pilates Exercises on Muscle Strength and Balance After Healed Lower Limb Burns</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study will be carried out on 76 patients suffering from lower limb burns with TBSA&#xD;
        ranging from 30% to 40%. The patients will be subdivided into two groups of equal number.&#xD;
  &#xD;
        Group (A): (The study group) who will receive Pilates exercise in addition to traditional&#xD;
        physical therapy programme in the form of stretching and strengthening exercises and deep&#xD;
        friction massage for scar management.&#xD;
  &#xD;
        Group (B): (The control group) who will receive traditional physical therapy programme only.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        1. subjects: The patients will be subdivided into two groups of equal number.&#xD;
  &#xD;
             Group A: (The study group):&#xD;
  &#xD;
             This group will be composed of 38 patients with lower limb burns. Patients will receive&#xD;
             Pilates exercise in addition to a traditional physical therapy programme in the form of&#xD;
             stretching exercises, strengthening exercises and deep friction massage for scar&#xD;
             management (3 sessions per week) for 8 weeks.&#xD;
  &#xD;
             1.2 Group B: (The control group): This group will be composed of 38 patients with lower&#xD;
             limb burns. Patients will receive a traditional physical therapy programme in the form&#xD;
             of stretching exercises, strengthening exercises and deep friction massage for scar&#xD;
             management (3 sessions per week) for 8 weeks.&#xD;
  &#xD;
          2. Equipment:&#xD;
  &#xD;
        Therapeutic equipment:&#xD;
  &#xD;
        Therapeutic equipment and tools in this study will include the following:&#xD;
  &#xD;
        a)Pilates exercises: The subjects will receive Pilates training (3 sessions/week) for 8&#xD;
        weeks. The Pilates training protocol will take 60 min per session, including 10 min of warm&#xD;
        up prior to initiating the Pilates technique, 40 min for Pilates exercises and 10 min for&#xD;
        cool down. The number of repetitions will be 10 times.&#xD;
  &#xD;
        The patient will perform the following Pilates exercises:&#xD;
  &#xD;
          1. Hundred exercises:&#xD;
  &#xD;
             Patients will be asked to lie in supine position with arms at their sides and knees bent&#xD;
             up in the air, then position their knees and hips in 90-degree angles. Then will be&#xD;
             instructed to curl their head and shoulders off the floor. The arms then move up and&#xD;
             down slowly, initiating the movement from the shoulder joint. The subjects will inhale&#xD;
             for a count of five and exhale for a count of five and this step will be repeated until&#xD;
             reach 100 counts.&#xD;
  &#xD;
          2. Spine stretch:&#xD;
  &#xD;
             Each patient will be asked to sit in a long sitting position with her legs extended out&#xD;
             in front of his with hip-distance apart, feet dorsiflexed. As he inhaled, his arms&#xD;
             should be stretched out in front of her with palms down then, Exhale and reach her feet;&#xD;
             keeping his arms parallel to the floor and contract the abdominal muscles, then inhale&#xD;
             and return to his starting position. Repeat 10 times.&#xD;
  &#xD;
          3. Single leg stretch:&#xD;
  &#xD;
             Patients will be asked to lie on their back and bring chin to chest, lifting head and&#xD;
             neck off mat. Bend right knee into chest and place left hand on right knee and right&#xD;
             hand on right ankle. Extend left leg off mat in Pilates stance while keeping lower back&#xD;
             on mat. Change legs and hand position. Inhale for 1 set (right and left) and exhale for&#xD;
             1 set.&#xD;
  &#xD;
          4. Double leg stretch:&#xD;
  &#xD;
             Each patient will be asked to lie on their back and bring chin to chest keeping chin to&#xD;
             chest, bend both knees into chest and places hands around ankles. Extend legs off mat in&#xD;
             Pilates stance and arms behind head. Open arms to sides and circle them around to ankles&#xD;
             again as knees bend in. Inhale as arms and legs bend and exhale as they extend.&#xD;
  &#xD;
          5. Criss cross:&#xD;
  &#xD;
             Patients will be asked to keep their chin to chest and hands behind head, bend knees so&#xD;
             legs form 90° angle above the mat. Bend right knee into chest and extend left leg in&#xD;
             Pilates stance. Twist left elbow towards right knee and look behind right elbow. Pass&#xD;
             through center, with legs bent at 90° angle above the mat and both sides of back on mat&#xD;
             and repeat to other side. Inhale when in center and exhale on twist.&#xD;
  &#xD;
          6. Swimming:&#xD;
  &#xD;
             Patients will be asked to lie on their stomach with legs extended together in Pilates&#xD;
             stance and arms extended in front of head shoulder width apart. Lift upper back, right&#xD;
             arm, and left leg, keeping arm and leg straight. Alternate lifting arms and legs, always&#xD;
             lifting the opposite arm and leg together, while keeping upper back lifted off mat.&#xD;
             Inhale for 10 counts and exhale for 10 counts.&#xD;
  &#xD;
          7. One leg kick:&#xD;
  &#xD;
             Patients will be asked to lie in the prone position, closing the back of the legs to the&#xD;
             same leg hamstring and firming the buttock while increasing their abdominal strength.&#xD;
  &#xD;
          8. Side kick:&#xD;
  &#xD;
             Each patient will be asked to lie on his left side, his shoulders, hips, and ankles on&#xD;
             the same line extended and his both legs slightly slide forward so he can see her toes.&#xD;
             Support his head on left arm as he inhaled, kick with his right leg to the level of the&#xD;
             hip twice while dorsi-flexing his foot. Then breathe out and relax. Repeat it 10 times&#xD;
             for each leg.&#xD;
  &#xD;
          9. Clam:&#xD;
  &#xD;
             Patients will be asked to lie on the side. Resting the head on the arm or hand, then&#xD;
             bend hips to approximately 45 and knees at 90. Make sure that one hip is lying above the&#xD;
             other. Upper leg upwards while keeping the feet in contact with one another.&#xD;
  &#xD;
         10. One leg circle:&#xD;
  &#xD;
             Patients will be asked to bring their thighs as perpendicular to the floor as possible.&#xD;
             Circle the leg down toward the mat, then out to the right, and finally back to center.&#xD;
  &#xD;
         11. Shoulder bridge:&#xD;
  &#xD;
             Each patient will be asked to lie in the crock line position then gently raise their&#xD;
             lower back until he is resting on his shoulder. Then breathe in and hold the position.&#xD;
             In this position lift one heel off the floor, then breathe out and lower it down. Repeat&#xD;
             10 times for each side.&#xD;
  &#xD;
         12. Hip twist:&#xD;
  &#xD;
             Patients will be asked to sit on a mat and extend their legs in front. The body should&#xD;
             be in the same position as a V-up. Rotate the hips to the right side of the body and&#xD;
             circle legs to the right and down.&#xD;
  &#xD;
         13. Roll up &amp; roll down:&#xD;
  &#xD;
             Each patient will be asked to lie flat on the mat, breathe in, dorsi-flex his feet and&#xD;
             raise his arms to 90 degrees, then try to raise his head and shoulders from the mat then&#xD;
             breathe out and relax. Repeat 10 times.&#xD;
  &#xD;
         14. Standing footwork:&#xD;
  &#xD;
        Patient will be in standing position in &quot;V stance&quot; While keeping the Pilates &quot;V&quot;, the&#xD;
        patients will be instructed to rise up on their toes as far as possible while keeping the&#xD;
        heels together. Then they lowered to the ground while keeping their spine neutral. Then the&#xD;
        patient will be instructed to perform a plié (bending at the hips and knees). The patient&#xD;
        will be instructed to breathe in deeply after beginning the movement and breathe out when&#xD;
        performing the movement.&#xD;
  &#xD;
        (b) Traditional physical therapy programme:&#xD;
  &#xD;
        All patients will receive a traditional physical therapy programme consisting of 45 minutes&#xD;
        per session of a supervised and individualized exercise programme for three sessions per week&#xD;
        for eight weeks which will include:&#xD;
  &#xD;
          1. Stretching exercises for calf and hamstring muscles by using the hold relax technique:&#xD;
  &#xD;
             - To achieve this, the limb will be placed at its limit of range and an isometric&#xD;
             contraction will be sustained (for 5 to 10 seconds), followed by a voluntary relaxation&#xD;
             of the tightened muscles. The limb will then be passively moved into the new range and&#xD;
             sustained the stretch for 30 seconds for 3 repetitions at each time.&#xD;
  &#xD;
          2. Strengthening exercises for hip, knee, ankle, and foot muscles:&#xD;
  &#xD;
               -  One repetition maximum test (1RM): The patients will be tested to determine the&#xD;
                  amount of weight or load that will be used during the first week (of the 8 weeks&#xD;
                  program) as baseline loads.&#xD;
  &#xD;
               -  To improve strength, free weights will be used for all exercises. During the first&#xD;
                  week, 50 to 60% of their individual 1RM will be set as the starting weight. Then,&#xD;
                  from the second week to the sixth, the weight will be increased to 70%-75% of their&#xD;
                  individual 1RM. The training amplitude will be then raised to 80%-85% of their&#xD;
                  individual 1RM that will be continued through weeks 7 and 8, holding 5 seconds at&#xD;
                  the end of the range. (Number of repetitions: 3 sets,10 repetitions in each).&#xD;
  &#xD;
          3. Deep friction massage for scar management:&#xD;
  &#xD;
        Deep circular movement by the balls of the thumb and sufficient drag will be applied to&#xD;
        mobilize the tissue; tension and shear force will be used first followed by lifting and skin&#xD;
        rolling when tissues become more pliable.&#xD;
  &#xD;
        Measuring equipment:&#xD;
  &#xD;
        a)Lafayette hand-held dynamometer (HHD): Hand-held dynamometer (HHD) is a convenient,&#xD;
        reliable and valid instrument for muscle strength assessment.&#xD;
  &#xD;
        In this study the Lafayette Manual Muscle Tester, Model # 01163, (Lafayette Instrument Inc.,&#xD;
        Lafayette, Indiana will be used for objectively quantifying the maximum isometric muscle&#xD;
        strength of knee extensors and knee flexors.&#xD;
  &#xD;
        knee extensors and flexors will be assessed while participants will be in a sitting position,&#xD;
        hips and knees 90° flexed. The dynamometer will be positioned above the ankle joint, on the&#xD;
        anterior aspect of the shank for assessing knee extensors, or on the posterior aspect of the&#xD;
        shank for measuring knee flexors (b) Berg balance scale (BBS): Berg Balance Scale (BBS) is&#xD;
        one of the most widely used tools for balance assessment. this scale has been shown to be a&#xD;
        valid and reliable measure of balance.&#xD;
  &#xD;
        The BBS consists of 14 items and has a maximum possible score of 56 points. It uses an&#xD;
        ordinal scoring system in which each detail is rated, 0 being the lowest and 4 being the&#xD;
        highest level of function.&#xD;
  &#xD;
        (c) Arabic version of lower extremity functional scale (LEFS): The Arabic version of lower&#xD;
        extremity functional scale will be used to assess lower limb functions. LEFS is an excellent&#xD;
        patient-reported outcome measure that can be used in clinical practice and for research&#xD;
        purposes to assess the level of activity limitation. The validity, reliability, and&#xD;
        responsiveness of the LEFS have been established for musculoskeletal disorders. LEFS has 20&#xD;
        items each scored on 0-4 Likert scale and the overall score on the scale is produced by&#xD;
        summing scores on all items. LEFS scores range from 0 to 80 with higher score indicating&#xD;
        better functional ability.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Lafayette hand-held dynamometer:</measure>
      <time_frame>8 weeks</time_frame>
      <description>The maximum isometric force of knee flexors and extensors will be measured before and after treatment period using Lafayette HHD. The MIF will be measured through an accommodating isometric &quot;make&quot; test, where participants applied maximal force against the examiner while a steady position was maintained. Participants will perform three, 5 seconds contractions for each muscle group with a 30 second rest after each trial and 5 minutes rest between muscle groups. The average force of the three testing trials will be computed for each muscle. The examiner encourages participants to do their best effort during measurement. Knee extensors and flexors are assessed while participants are in a sitting position, hips and knees 90° flexed. The dynamometer is positioned above the ankle joint, on the anterior aspect of the shank for assessing knee extensors, or on the posterior aspect of the shank for measuring knee flexors.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Berg balance scale:</measure>
      <time_frame>8 weeks</time_frame>
      <description>it consists of 14 items representing functional movements common in everyday life. Some items require that the patient maintain positions of increasing difficulty, from sitting to standing on one leg. Other items evaluate the ability to perform specific tasks, such as reaching forward, turning around and picking up an object from the floor. Scoring is based on the ability to meet certain time or distance requirements and to perform the items independently. Each task is scored on a 5-point scale from 0 to 4, giving a maximum score of 56, which indicates balance ability within the normal range.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Arabic version of Lower extremity functional scale</measure>
      <time_frame>8 weeks</time_frame>
      <description>it was translated to the classical Arabic language to enhance the use of the scale in all Arabic-speaking countries.&#xD;
  Lower extremity functional scale (LEFS) is a patient-reported measure to examine the functional status in the presence of lower extremity musculoskeletal problems. The LEFS consists of 20 items, with scores ranging from 0 (extreme difficulty/unable to perform activity) to 4 (no difficulty). The total score can be obtained by summing the scores of the individual items. The maximum score of 80 indicates no functional limitations and the minimum score of 0 indicates extreme limitations.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">76</enrollment>
    <condition>Lower Limb Burns</condition>
    <arm_group>
      <arm_group_label>(Pilates exercises plus traditional physical therapy programme)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Pilates exercises: The Pilates training protocol will take 60 min per session, including 10 min of warm up prior to initiating the Pilates technique, 40 min for Pilates exercises and 10 min for cool down. The number of repetitions will be 10 times. The patient will perform the following Pilates exercises: (Hundred exercises, spine stretch, single leg stretch , double leg stretch, criss cross, swimming, one leg kick, side kick, clam, one leg circle, shoulder bridge, hip twist, roll up and down and standing footwork).Pilates training (3 sessions/week) for 8 weeks.&#xD;
  traditional physical therapy programme: consisting of a supervised and individualized exercise programme for three sessions per week for eight weeks which will include:&#xD;
  Stretching exercises for calf and hamstring muscles by using the hold relax technique.&#xD;
  Strengthening exercises for hip, knee, ankle, and foot muscles.&#xD;
  Deep friction massage for scar management:</description>
    </arm_group>
    <arm_group>
      <arm_group_label>(traditional physical therapy programme)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All patients will receive a traditional physical therapy programme consisting of a supervised and individualized exercise programme for three sessions per week for eight weeks which will include:&#xD;
  Stretching exercises for calf and hamstring muscles by using the hold relax technique.&#xD;
  Strengthening exercises for hip, knee, ankle, and foot muscles.&#xD;
  Deep friction massage for scar management:</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Pilates exercises</intervention_name>
      <description>Pilates exercises:&#xD;
  The subjects will receive Pilates training (3 sessions/week) for 8 weeks. The Pilates training protocol will take 60 min per session, including 10 min of warm up prior to initiating the Pilates technique, 40 min for Pilates exercises and 10 min for cool down. The number of repetitions will be 10 times. The patient will perform the following Pilates exercises: (Hundred exercises, spine stretch, single leg stretch , double leg stretch, criss cross, swimming, one leg kick, side kick, clam, one leg circle, shoulder bridge, hip twist, roll up and down and standing footwork).</description>
      <arm_group_label>(Pilates exercises plus traditional physical therapy programme)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Traditional physical therapy programme:</intervention_name>
      <description>All patients will receive a traditional physical therapy programme consisting of 45 minutes per session of a supervised and individualized exercise programme for three sessions per week for eight weeks which will include:&#xD;
  Stretching exercises for calf and hamstring muscles by using the hold relax technique.&#xD;
  Strengthening exercises for hip, knee, ankle, and foot muscles. Deep friction massage for scar management.</description>
      <arm_group_label>(Pilates exercises plus traditional physical therapy programme)</arm_group_label>
      <arm_group_label>(traditional physical therapy programme)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The patients will be chosen under the following criteria:&#xD;
  &#xD;
            -  Patients of both genders will participate in this study.&#xD;
  &#xD;
            -  Their ages from 20-40 years old.&#xD;
  &#xD;
            -  Patients with lower limb second degree burn (partial thickness of thermal injury) will&#xD;
               participate in this study.&#xD;
  &#xD;
            -  Total body surface area (TBSA) for the burns will be ranged from 30% to 40%.&#xD;
  &#xD;
            -  Patients will begin the training programme after one month of complete wound healing.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The current study will exclude the following patients:&#xD;
  &#xD;
            -  Patients with an open wound at or near the treatment site.&#xD;
  &#xD;
            -  Patients with chemical or electrical burns.&#xD;
  &#xD;
            -  Patients with musculoskeletal disorders that will impair performance during training&#xD;
               and tests.&#xD;
  &#xD;
            -  Patients with neurological disorders.&#xD;
  &#xD;
            -  Patients with metabolic or vascular disease with a neurological component such as&#xD;
               diabetes.&#xD;
  &#xD;
            -  Malignant conditions.&#xD;
  &#xD;
            -  Psychiatric illness, severe behavior or cognitive disorders.&#xD;
  &#xD;
            -  Uncooperative patients.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Yasmeen Hamada Lotfy Mohamed</investigator_full_name>
      <investigator_title>Assistant Lecturer at Department of Surgery and Burn - Faculty of Physical Therapy - Cairo University</investigator_title>
    </responsible_party>
    <keyword>Pilates exercises</keyword>
    <keyword>Muscle strength</keyword>
    <keyword>Balance</keyword>
    <keyword>Lower limb burns</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Burns</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05991479
  org study id: 286206
  nct id: NCT05991479
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The study will be carried out on 76 patients suffering from lower limb burns with TBSA
        ranging from 30% to 40%. The patients will be subdivided into two groups of equal number.
  
        Group (A): (The study group) who will receive Pilates exercise in addition to traditional
        physical therapy programme in the form of stretching and strengthening exercises and deep
        friction massage for scar management.
  
        Group (B): (The control group) who will receive traditional physical therapy programme only.
  1. subjects: The patients will be subdivided into two groups of equal number.
  
             Group A: (The study group):
  
             This group will be composed of 38 patients with lower limb burns. Patients will receive
             Pilates exercise in addition to a traditional physical therapy programme in the form of
             stretching exercises, strengthening exercises and deep friction massage for scar
             management (3 sessions per week) for 8 weeks.
  
             1.2 Group B: (The control group): This group will be composed of 38 patients with lower
             limb burns. Patients will receive a traditional physical therapy programme in the form
             of stretching exercises, strengthening exercises and deep friction massage for scar
             management (3 sessions per week) for 8 weeks.
  
          2. Equipment:
  
        Therapeutic equipment:
  
        Therapeutic equipment and tools in this study will include the following:
  
        a)Pilates exercises: The subjects will receive Pilates training (3 sessions/week) for 8
        weeks. The Pilates training protocol will take 60 min per session, including 10 min of warm
        up prior to initiating the Pilates technique, 40 min for Pilates exercises and 10 min for
        cool down. The number of repetitions will be 10 times.
  
        The patient will perform the following Pilates exercises:
  
          1. Hundred exercises:
  
             Patients will be asked to lie in supine position with arms at their sides and knees bent
             up in the air, then position their knees and hips in 90-degree angles. Then will be
             instructed to curl their head and shoulders off the floor. The arms then move up and
             down slowly, initiating the movement from the shoulder joint. The subjects will inhale
             for a count of five and exhale for a count of five and this step will be repeated until
             reach 100 counts.
  
          2. Spine stretch:
  
             Each patient will be asked to sit in a long sitting position with her legs extended out
             in front of his with hip-distance apart, feet dorsiflexed. As he inhaled, his arms
             should be stretched out in front of her with palms down then, Exhale and reach her feet;
             keeping his arms parallel to the floor and contract the abdominal muscles, then inhale
             and return to his starting position. Repeat 10 times.
  
          3. Single leg stretch:
  
             Patients will be asked to lie on their back and bring chin to chest, lifting head and
             neck off mat. Bend right knee into chest and place left hand on right knee and right
             hand on right ankle. Extend left leg off mat in Pilates stance while keeping lower back
             on mat. Change legs and hand position. Inhale for 1 set (right and left) and exhale for
             1 set.
  
          4. Double leg stretch:
  
             Each patient will be asked to lie on their back and bring chin to chest keeping chin to
             chest, bend both knees into chest and places hands around ankles. Extend legs off mat in
             Pilates stance and arms behind head. Open arms to sides and circle them around to ankles
             again as knees bend in. Inhale as arms and legs bend and exhale as they extend.
  
          5. Criss cross:
  
             Patients will be asked to keep their chin to chest and hands behind head, bend knees so
             legs form 90° angle above the mat. Bend right knee into chest and extend left leg in
             Pilates stance. Twist left elbow towards right knee and look behind right elbow. Pass
             through center, with legs bent at 90° angle above the mat and both sides of back on mat
             and repeat to other side. Inhale when in center and exhale on twist.
  
          6. Swimming:
  
             Patients will be asked to lie on their stomach with legs extended together in Pilates
             stance and arms extended in front of head shoulder width apart. Lift upper back, right
             arm, and left leg, keeping arm and leg straight. Alternate lifting arms and legs, always
             lifting the opposite arm and leg together, while keeping upper back lifted off mat.
             Inhale for 10 counts and exhale for 10 counts.
  
          7. One leg kick:
  
             Patients will be asked to lie in the prone position, closing the back of the legs to the
             same leg hamstring and firming the buttock while increasing their abdominal strength.
  
          8. Side kick:
  
             Each patient will be asked to lie on his left side, his shoulders, hips, and ankles on
             the same line extended and his both legs slightly slide forward so he can see her toes.
             Support his head on left arm as he inhaled, kick with his right leg to the level of the
             hip twice while dorsi-flexing his foot. Then breathe out and relax. Repeat it 10 times
             for each leg.
  
          9. Clam:
  
             Patients will be asked to lie on the side. Resting the head on the arm or hand, then
             bend hips to approximately 45 and knees at 90. Make sure that one hip is lying above the
             other. Upper leg upwards while keeping the feet in contact with one another.
  
         10. One leg circle:
  
             Patients will be asked to bring their thighs as perpendicular to the floor as possible.
             Circle the leg down toward the mat, then out to the right, and finally back to center.
  
         11. Shoulder bridge:
  
             Each patient will be asked to lie in the crock line position then gently raise their
             lower back until he is resting on his shoulder. Then breathe in and hold the position.
             In this position lift one heel off the floor, then breathe out and lower it down. Repeat
             10 times for each side.
  
         12. Hip twist:
  
             Patients will be asked to sit on a mat and extend their legs in front. The body should
             be in the same position as a V-up. Rotate the hips to the right side of the body and
             circle legs to the right and down.
  
         13. Roll up & roll down:
  
             Each patient will be asked to lie flat on the mat, breathe in, dorsi-flex his feet and
             raise his arms to 90 degrees, then try to raise his head and shoulders from the mat then
             breathe out and relax. Repeat 10 times.
  
         14. Standing footwork:
  
        Patient will be in standing position in "V stance" While keeping the Pilates "V", the
        patients will be instructed to rise up on their toes as far as possible while keeping the
        heels together. Then they lowered to the ground while keeping their spine neutral. Then the
        patient will be instructed to perform a plié (bending at the hips and knees). The patient
        will be instructed to breathe in deeply after beginning the movement and breathe out when
        performing the movement.
  
        (b) Traditional physical therapy programme:
  
        All patients will receive a traditional physical therapy programme consisting of 45 minutes
        per session of a supervised and individualized exercise programme for three sessions per week
        for eight weeks which will include:
  
          1. Stretching exercises for calf and hamstring muscles by using the hold relax technique:
  
             - To achieve this, the limb will be placed at its limit of range and an isometric
             contraction will be sustained (for 5 to 10 seconds), followed by a voluntary relaxation
             of the tightened muscles. The limb will then be passively moved into the new range and
             sustained the stretch for 30 seconds for 3 repetitions at each time.
  
          2. Strengthening exercises for hip, knee, ankle, and foot muscles:
  
               -  One repetition maximum test (1RM): The patients will be tested to determine the
                  amount of weight or load that will be used during the first week (of the 8 weeks
                  program) as baseline loads.
  
               -  To improve strength, free weights will be used for all exercises. During the first
                  week, 50 to 60% of their individual 1RM will be set as the starting weight. Then,
                  from the second week to the sixth, the weight will be increased to 70%-75% of their
                  individual 1RM. The training amplitude will be then raised to 80%-85% of their
                  individual 1RM that will be continued through weeks 7 and 8, holding 5 seconds at
                  the end of the range. (Number of repetitions: 3 sets,10 repetitions in each).
  
          3. Deep friction massage for scar management:
  
        Deep circular movement by the balls of the thumb and sufficient drag will be applied to
        mobilize the tissue; tension and shear force will be used first followed by lifting and skin
        rolling when tissues become more pliable.
  
        Measuring equipment:
  
        a)Lafayette hand-held dynamometer (HHD): Hand-held dynamometer (HHD) is a convenient,
        reliable and valid instrument for muscle strength assessment.
  
        In this study the Lafayette Manual Muscle Tester, Model # 01163, (Lafayette Instrument Inc.,
        Lafayette, Indiana will be used for objectively quantifying the maximum isometric muscle
        strength of knee extensors and knee flexors.
  
        knee extensors and flexors will be assessed while participants will be in a sitting position,
        hips and knees 90° flexed. The dynamometer will be positioned above the ankle joint, on the
        anterior aspect of the shank for assessing knee extensors, or on the posterior aspect of the
        shank for measuring knee flexors (b) Berg balance scale (BBS): Berg Balance Scale (BBS) is
        one of the most widely used tools for balance assessment. this scale has been shown to be a
        valid and reliable measure of balance.
  
        The BBS consists of 14 items and has a maximum possible score of 56 points. It uses an
        ordinal scoring system in which each detail is rated, 0 being the lowest and 4 being the
        highest level of function.
  
        (c) Arabic version of lower extremity functional scale (LEFS): The Arabic version of lower
        extremity functional scale will be used to assess lower limb functions. LEFS is an excellent
        patient-reported outcome measure that can be used in clinical practice and for research
        purposes to assess the level of activity limitation. The validity, reliability, and
        responsiveness of the LEFS have been established for musculoskeletal disorders. LEFS has 20
        items each scored on 0-4 Likert scale and the overall score on the scale is produced by
        summing scores on all items. LEFS scores range from 0 to 80 with higher score indicating
        better functional ability.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Lafayette hand-held dynamometer:
  time frame: 8 weeks
  description: The maximum isometric force of knee flexors and extensors will be measured before and after treatment period using Lafayette HHD. The MIF will be measured through an accommodating isometric "make" test, where participants applied maximal force against the examiner while a steady position was maintained. Participants will perform three, 5 seconds contractions for each muscle group with a 30 second rest after each trial and 5 minutes rest between muscle groups. The average force of the three testing trials will be computed for each muscle. The examiner encourages participants to do their best effort during measurement. Knee extensors and flexors are assessed while participants are in a sitting position, hips and knees 90° flexed. The dynamometer is positioned above the ankle joint, on the anterior aspect of the shank for assessing knee extensors, or on the posterior aspect of the shank for measuring knee flexors.
  measure: Berg balance scale:
  time frame: 8 weeks
  description: it consists of 14 items representing functional movements common in everyday life. Some items require that the patient maintain positions of increasing difficulty, from sitting to standing on one leg. Other items evaluate the ability to perform specific tasks, such as reaching forward, turning around and picking up an object from the floor. Scoring is based on the ability to meet certain time or distance requirements and to perform the items independently. Each task is scored on a 5-point scale from 0 to 4, giving a maximum score of 56, which indicates balance ability within the normal range.
  measure: Arabic version of Lower extremity functional scale
  time frame: 8 weeks
  description: it was translated to the classical Arabic language to enhance the use of the scale in all Arabic-speaking countries.
  Lower extremity functional scale (LEFS) is a patient-reported measure to examine the functional status in the presence of lower extremity musculoskeletal problems. The LEFS consists of 20 items, with scores ranging from 0 (extreme difficulty/unable to perform activity) to 4 (no difficulty). The total score can be obtained by summing the scores of the individual items. The maximum score of 80 indicates no functional limitations and the minimum score of 0 indicates extreme limitations.
  arm group label: (Pilates exercises plus traditional physical therapy programme)
  arm group type: Experimental
  description: Pilates exercises: The Pilates training protocol will take 60 min per session, including 10 min of warm up prior to initiating the Pilates technique, 40 min for Pilates exercises and 10 min for cool down. The number of repetitions will be 10 times. The patient will perform the following Pilates exercises: (Hundred exercises, spine stretch, single leg stretch , double leg stretch, criss cross, swimming, one leg kick, side kick, clam, one leg circle, shoulder bridge, hip twist, roll up and down and standing footwork).Pilates training (3 sessions/week) for 8 weeks.
  traditional physical therapy programme: consisting of a supervised and individualized exercise programme for three sessions per week for eight weeks which will include:
  Stretching exercises for calf and hamstring muscles by using the hold relax technique.
  Strengthening exercises for hip, knee, ankle, and foot muscles.
  Deep friction massage for scar management:
  arm group label: (traditional physical therapy programme)
  arm group type: Experimental
  description: All patients will receive a traditional physical therapy programme consisting of a supervised and individualized exercise programme for three sessions per week for eight weeks which will include:
  Stretching exercises for calf and hamstring muscles by using the hold relax technique.
  Strengthening exercises for hip, knee, ankle, and foot muscles.
  Deep friction massage for scar management:
  intervention type: Other
  intervention name: Pilates exercises
  description: Pilates exercises:
  The subjects will receive Pilates training (3 sessions/week) for 8 weeks. The Pilates training protocol will take 60 min per session, including 10 min of warm up prior to initiating the Pilates technique, 40 min for Pilates exercises and 10 min for cool down. The number of repetitions will be 10 times. The patient will perform the following Pilates exercises: (Hundred exercises, spine stretch, single leg stretch , double leg stretch, criss cross, swimming, one leg kick, side kick, clam, one leg circle, shoulder bridge, hip twist, roll up and down and standing footwork).
  arm group label: (Pilates exercises plus traditional physical therapy programme)
  intervention type: Other
  intervention name: Traditional physical therapy programme:
  description: All patients will receive a traditional physical therapy programme consisting of 45 minutes per session of a supervised and individualized exercise programme for three sessions per week for eight weeks which will include:
  Stretching exercises for calf and hamstring muscles by using the hold relax technique.
  Strengthening exercises for hip, knee, ankle, and foot muscles. Deep friction massage for scar management.
  arm group label: (Pilates exercises plus traditional physical therapy programme)
  arm group label: (traditional physical therapy programme)
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 40 Years
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Yasmeen Hamada Lotfy Mohamed
  investigator title: Assistant Lecturer at Department of Surgery and Burn - Faculty of Physical Therapy - Cairo University
  mesh term: Burns