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/NCT06010706</url>
    </required_header>
    <id_info>
      <org_study_id>123456</org_study_id>
      <nct_id>NCT06010706</nct_id>
    </id_info>
    <brief_title>Supervised Manual Physical Therapy Exercise for Ankle Disability After Motor Vehicle Accidents.</brief_title>
    <official_title>Efficacy of Supervised Manual Physical Therapy Exercise for Ankle Disability After Motor Vehicle Accidents, Randomized Controlled Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jouf University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Jouf University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Every year more than 50 million people worldwide are injured due to RTAs which in turn makes&#xD;
        it one of the leading causes of disability. During automobile collisions, the lower limbs are&#xD;
        the most commonly injured region of the human body. Ankle injuries can be particularly&#xD;
        long-lasting, resulting in excessive medical costs, inability to work, and serious&#xD;
        psychological distress. Physiotherapists often contribute to the rehabilitation of ankle&#xD;
        fractures, which typically starts soon after the period of immobilization. Joint mobilization&#xD;
        led to increased ankle movement, improved gait patterns, reduced pain and the number of&#xD;
        treatment sessions required, and hastened return to activities when compared with the usual&#xD;
        rest, ice, compression, and elevation protocol.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participants will be assigned into two groups:&#xD;
  &#xD;
          1. Study group will receive a Supervised physical therapy exercise program in the form of&#xD;
             Mobilization exercise, Stretching exercise, and Strengthening exercise.&#xD;
  &#xD;
          2. Control group will receive a Home-based exercise program of Stretching exercises,&#xD;
             strengthening exercises and ROM exercises.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 25, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2024</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>1. EMG assessment of muscle activity:</measure>
      <time_frame>2 momths</time_frame>
      <description>Electromyogram (EMG) is the recording of the muscle activity and in this study EMG will be recorded from the tibialis anterior (TA) and the triceps surae muscle groups: medial gastrocnemius (MG), lateral gastrocnemius (LG) and soleus (SOL). Myomonitor 4 (Delsys, Boston) EMG data acquisition system was used. This has a gain of 1000, CMRR of 92 dB and bandwidth of 20-450 Hz, and 12 dB/octave roll-off. The sampling rate was 1000 Hz with a resolution of 16 bits/sample. Delsys single-channel active differential silver bar (10 mm x 1 mm) were used to record EMG. These will be embedded preamplifiers and fixed inter-electrode distance of 10 mm.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Dynamic Plantar Pressure</measure>
      <time_frame>2 months.</time_frame>
      <description>Dynamic plantar pressure was recorded using a single BTS P-WALK pressure platform (BTS Bioengineering S.p.A. Italy), with dimensions 640 mm _ 740 mm _ 8 mm and an acquisition frequency of 250 Hz. Data transmission to the computer is via USB2, where specific software (BTS G-Studio) processes the information received. The software itself identifies each step performed, and in the processing, the researchers themselves (M.F.-G. and D.S.-G.) take care of eliminating incorrect or incomplete steps .&#xD;
  For data collection, the pressure platform was placed in the intermediate part (4 m) of the walkway. In this way, for step standardization, we ensured that at least three steps were taken before stepping on the plate. Five steps were collected with each limb during a continuous gait cycle. The variables recorded using the pressure platform were: weight-normalised peak plantar pressure (PPP) (kPa)-peak pressure recorded from the total number of steps taken during the gait.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Berg Balance Scale (BBS):</measure>
      <time_frame>2 months.</time_frame>
      <description>The Berg balance scale includes 14 items with scores from 0 to 4. A score of 0 represents the inability to do the task, while a score of 4 represents the ability to do the task completely, according to the assigned criteria, with 56 indicates the total score. Items range from tasks of simple mobility (e.g. transfers, standing unsupported, sit-to-stand) to tasks with greater difficulty.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ankle Joint Dorsiflexion and Planterflexion Range (ROM):</measure>
      <time_frame>2 months.</time_frame>
      <description>Passive ankle-dorsiflexion and planterflexion ROM will be measured in 2 positions (extended knee and flexed knee) using a standard manual goniometer. For the extended-knee assessment, Patients will be seated on a treatment table with the knees fully extended (0°) and the feet hanging off the end of the table. For the flexed-knee assessment, they will be seated with the popliteal space at the edge of the table and the knees in 90° of flexion. For each ROM measurement, the participant will be completely relaxed; the investigator will passively moved the ankle into dorsiflexion and planterflexion from a neutral starting position (ie, 90° angle between shank and foot segments) until a firm end feel will be elicited. The axis of the goniometer will be centered over the lateral malleolus and the arms will be aligned with the fibular shaft and the head of the fifth metatarsal.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain Assessment.</measure>
      <time_frame>2 months.</time_frame>
      <description>By numerical rating scale: The 11-point numerical pain rating scale was used in this study to indicate the intensity pain. It is composed of a numeric segmented horizontal line ranging from 0 which represents &quot;no pain&quot; and 10 which represents &quot;worst imaginable pain.&quot; The scale was explained to each participant before using to ensure efficiency. Each participant was instructed to choose a numerical value (from 0 to 10 integers) that best describes the intensity of his pain in the preceding 24 hours.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Ankle Deformity</condition>
    <arm_group>
      <arm_group_label>Supervised Manual Physical Therapy Program</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive a supervised physical therapy program including: mobilizing exercises, stretching exercises, and strengthening exercises. 3 sessions a week for eight consecutive weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Home based exercise program:</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients at the control group will receive instruction for home based exercise program of physical therapy exercise. The home program primarily consisted of exercises targeting deficits in joint ROM, muscle flexibility and strength, and balance. The home-based program will include stretching, ROM and strengthening exercises</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Supervised physical therapy manual exercise program.</intervention_name>
      <description>Mobilization Techniques :&#xD;
  The joint mobilization technique will be the anterior-posterior glide of the talus. The participant will be positioned in supine or long sitting.&#xD;
  Stretching Exercise:&#xD;
  Passive stretching with therapist assistance was used for ankle dorsiflexion with the knee both flexed and extended. Force during passive stretching was modified to patient tolerance. Each participant flexed the knee slightly while standing on a 10° incline board. The participant was asked to slightly flex both knees until a stretch was felt in the calf muscle.&#xD;
  Strengthening Exercise:&#xD;
  The resistance training protocol will be based on the progressive resistance training principle and was a modification of the protocol used by Frontera et al [10] in older men. Plantar-flexion resistance training will be performed on a customized hydraulic apparatus, which provide a constant resistance over the entire ROM and allow for concentric as well as eccentric.</description>
      <arm_group_label>Supervised Manual Physical Therapy Program</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Stretching exercise, ROM, Strengthening exercises.</intervention_name>
      <description>Patients at the control group will receive instruction for home based exercise program of physical therapy exercise. The home program primarily consisted of exercises targeting deficits in joint ROM, muscle flexibility and strength, and balance.</description>
      <arm_group_label>Home based exercise program:</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with Stable ankle fractures after motor vehicle accidents involving the&#xD;
               distal tibia, distal fibula, or talus treated with cast immobilization, with the&#xD;
               removed cast in the preceding seven days.&#xD;
  &#xD;
            -  Approval from the orthopedic specialist to weight-bear as tolerated or partial&#xD;
               weight-bear. -- Their ages will be between the age of 18 to 50 years of age.&#xD;
  &#xD;
            -  Participants having no concurrent injuries or pathology, such as neurological injury&#xD;
               or other fractures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with surgical fixation,&#xD;
  &#xD;
            -  Fracture malunion or nonunion,&#xD;
  &#xD;
            -  Syndesmosis injury, or any standard contraindication to manual physical therapy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 26, 2023</last_update_submitted>
    <last_update_submitted_qc>August 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Jouf University</investigator_affiliation>
      <investigator_full_name>Mosaad</investigator_full_name>
      <investigator_title>Principal investigator, PhD , Department of physical therapy and Health Rehabilitation, College of applied medical sciences, Jouf University.</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Congenital Abnormalities</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Data will be shared after 6 months of publication.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>6 Months after publication.</ipd_time_frame>
      <ipd_access_criteria>The study protocol and Informed Consent form will be shared after 6 months of publication.</ipd_access_criteria>
    </patient_data>
    <!-- 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/NCT06010706
  org study id: 123456
  nct id: NCT06010706
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Every year more than 50 million people worldwide are injured due to RTAs which in turn makes
        it one of the leading causes of disability. During automobile collisions, the lower limbs are
        the most commonly injured region of the human body. Ankle injuries can be particularly
        long-lasting, resulting in excessive medical costs, inability to work, and serious
        psychological distress. Physiotherapists often contribute to the rehabilitation of ankle
        fractures, which typically starts soon after the period of immobilization. Joint mobilization
        led to increased ankle movement, improved gait patterns, reduced pain and the number of
        treatment sessions required, and hastened return to activities when compared with the usual
        rest, ice, compression, and elevation protocol.
  Participants will be assigned into two groups:
  
          1. Study group will receive a Supervised physical therapy exercise program in the form of
             Mobilization exercise, Stretching exercise, and Strengthening exercise.
  
          2. Control group will receive a Home-based exercise program of Stretching exercises,
             strengthening exercises and ROM exercises.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: 1. EMG assessment of muscle activity:
  time frame: 2 momths
  description: Electromyogram (EMG) is the recording of the muscle activity and in this study EMG will be recorded from the tibialis anterior (TA) and the triceps surae muscle groups: medial gastrocnemius (MG), lateral gastrocnemius (LG) and soleus (SOL). Myomonitor 4 (Delsys, Boston) EMG data acquisition system was used. This has a gain of 1000, CMRR of 92 dB and bandwidth of 20-450 Hz, and 12 dB/octave roll-off. The sampling rate was 1000 Hz with a resolution of 16 bits/sample. Delsys single-channel active differential silver bar (10 mm x 1 mm) were used to record EMG. These will be embedded preamplifiers and fixed inter-electrode distance of 10 mm.
  measure: Dynamic Plantar Pressure
  time frame: 2 months.
  description: Dynamic plantar pressure was recorded using a single BTS P-WALK pressure platform (BTS Bioengineering S.p.A. Italy), with dimensions 640 mm _ 740 mm _ 8 mm and an acquisition frequency of 250 Hz. Data transmission to the computer is via USB2, where specific software (BTS G-Studio) processes the information received. The software itself identifies each step performed, and in the processing, the researchers themselves (M.F.-G. and D.S.-G.) take care of eliminating incorrect or incomplete steps .
  For data collection, the pressure platform was placed in the intermediate part (4 m) of the walkway. In this way, for step standardization, we ensured that at least three steps were taken before stepping on the plate. Five steps were collected with each limb during a continuous gait cycle. The variables recorded using the pressure platform were: weight-normalised peak plantar pressure (PPP) (kPa)-peak pressure recorded from the total number of steps taken during the gait.
  measure: Berg Balance Scale (BBS):
  time frame: 2 months.
  description: The Berg balance scale includes 14 items with scores from 0 to 4. A score of 0 represents the inability to do the task, while a score of 4 represents the ability to do the task completely, according to the assigned criteria, with 56 indicates the total score. Items range from tasks of simple mobility (e.g. transfers, standing unsupported, sit-to-stand) to tasks with greater difficulty.
  measure: Ankle Joint Dorsiflexion and Planterflexion Range (ROM):
  time frame: 2 months.
  description: Passive ankle-dorsiflexion and planterflexion ROM will be measured in 2 positions (extended knee and flexed knee) using a standard manual goniometer. For the extended-knee assessment, Patients will be seated on a treatment table with the knees fully extended (0°) and the feet hanging off the end of the table. For the flexed-knee assessment, they will be seated with the popliteal space at the edge of the table and the knees in 90° of flexion. For each ROM measurement, the participant will be completely relaxed; the investigator will passively moved the ankle into dorsiflexion and planterflexion from a neutral starting position (ie, 90° angle between shank and foot segments) until a firm end feel will be elicited. The axis of the goniometer will be centered over the lateral malleolus and the arms will be aligned with the fibular shaft and the head of the fifth metatarsal.
  measure: Pain Assessment.
  time frame: 2 months.
  description: By numerical rating scale: The 11-point numerical pain rating scale was used in this study to indicate the intensity pain. It is composed of a numeric segmented horizontal line ranging from 0 which represents "no pain" and 10 which represents "worst imaginable pain." The scale was explained to each participant before using to ensure efficiency. Each participant was instructed to choose a numerical value (from 0 to 10 integers) that best describes the intensity of his pain in the preceding 24 hours.
  arm group label: Supervised Manual Physical Therapy Program
  arm group type: Experimental
  description: Participants will receive a supervised physical therapy program including: mobilizing exercises, stretching exercises, and strengthening exercises. 3 sessions a week for eight consecutive weeks.
  arm group label: Home based exercise program:
  arm group type: Active Comparator
  description: Patients at the control group will receive instruction for home based exercise program of physical therapy exercise. The home program primarily consisted of exercises targeting deficits in joint ROM, muscle flexibility and strength, and balance. The home-based program will include stretching, ROM and strengthening exercises
  intervention type: Other
  intervention name: Supervised physical therapy manual exercise program.
  description: Mobilization Techniques :
  The joint mobilization technique will be the anterior-posterior glide of the talus. The participant will be positioned in supine or long sitting.
  Stretching Exercise:
  Passive stretching with therapist assistance was used for ankle dorsiflexion with the knee both flexed and extended. Force during passive stretching was modified to patient tolerance. Each participant flexed the knee slightly while standing on a 10° incline board. The participant was asked to slightly flex both knees until a stretch was felt in the calf muscle.
  Strengthening Exercise:
  The resistance training protocol will be based on the progressive resistance training principle and was a modification of the protocol used by Frontera et al [10] in older men. Plantar-flexion resistance training will be performed on a customized hydraulic apparatus, which provide a constant resistance over the entire ROM and allow for concentric as well as eccentric.
  arm group label: Supervised Manual Physical Therapy Program
  intervention type: Other
  intervention name: Stretching exercise, ROM, Strengthening exercises.
  description: Patients at the control group will receive instruction for home based exercise program of physical therapy exercise. The home program primarily consisted of exercises targeting deficits in joint ROM, muscle flexibility and strength, and balance.
  arm group label: Home based exercise program:
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Jouf University
  investigator full name: Mosaad
  investigator title: Principal investigator, PhD , Department of physical therapy and Health Rehabilitation, College of applied medical sciences, Jouf University.
  mesh term: Congenital Abnormalities
  sharing ipd: Yes
  ipd description: Data will be shared after 6 months of publication.
  ipd info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: 6 Months after publication.
  ipd access criteria: The study protocol and Informed Consent form will be shared after 6 months of publication.