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/NCT06013631</url>
    </required_header>
    <id_info>
      <org_study_id>Fiza Komal</org_study_id>
      <nct_id>NCT06013631</nct_id>
    </id_info>
    <brief_title>Effects of Prosthesis Training on Pain, Prosthesis Satisfaction and Ambulatory Status of Lower Limb Amputees</brief_title>
    <official_title>Effects of Prosthesis Training With and Without Phantom Exercises on Pain, Prosthesis Satisfaction and Ambulatory Status of Lower Limb Amputees</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Lahore</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Lahore</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>
        The objective of the study is to assess the effects of prosthesis training with and without&#xD;
        phantom exercises on pain, prosthesis satisfaction and ambulatory status of lower limb&#xD;
        amputees treated with prosthesis training, phantom exercises and routine physical therapy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Amputation is a catastrophic incident in a person's life which resulted in psychological,&#xD;
        social and physical consequences. Loss of extremity resulted in negative impact on patient's&#xD;
        body and perception as well. Phantom limb pain (PLP) can be defined by discomfort or pain in&#xD;
        lost part of limb experienced by lower limb amputees. Phantom limb pain is physically and&#xD;
        mentally draining condition which affects patient's daily activities like personal care and&#xD;
        functional independence.&#xD;
  &#xD;
        Phantom limb pain is highly prevalent condition among lower limb amputees. It is associated&#xD;
        with negative effect on mental and physical health conditions. There are studies conducted on&#xD;
        prosthesis training for prosthesis satisfaction.&#xD;
  &#xD;
        However, according to researcher knowledge effects of prosthesis training along with phantom&#xD;
        exercises have not been measured on prosthesis satisfaction. This study will encourage future&#xD;
        studies on this topic and will help in developing state of art treatment of phantom limb&#xD;
        discomfort associated with lower limb subtraction. As managing phantom discomfort can result&#xD;
        in better prosthesis satisfaction and eventually ease the ambulatory status of patient.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">September 7, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 21, 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>Single (Outcomes Assessor)</masking>
      <masking_description>The accessor will be unaware of treatment group.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Prosthesis satisfaction level</measure>
      <time_frame>It will be assessed at 6th week after the application of intervention.</time_frame>
      <description>To check prosthesis satisfaction of the amputees, Trinity Amputation and Prosthesis Experience Scales (TAPES) will be used. It assesses prosthetic satisfaction on the basis of the functional, aesthetic, and weight subscales. TAPES evaluates how well people adjust to physical limitations that may have an impact on social behavior.Scores range from 5 to 25, with higher scores indicating greater levels of adjustment.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Phantom Limb Pain Intensity</measure>
      <time_frame>Pain intensity will be assessed at baseline and any change in pain intensity will be measured at 6th week of intervention.</time_frame>
      <description>To check prosthesis satisfaction of the amputees, Trinity Amputation and Prosthesis Experience Scales (TAPES) will be used. It assesses prosthetic satisfaction on the basis of the functional, aesthetic, and weight subscales. TAPES evaluates how well people adjust to physical limitations that may have an impact on social behavior.&#xD;
  visual analogue scale (VAS) can be used to aid someone to assess the strength of particular moods and experiences, such as pain. The visual analogue scale for pain is a conventional, with the lowest likely discomfort at one end and no pain at the other.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Ambulation Status</measure>
      <time_frame>Ambulation status will be observed at baseline and any change will be assessed at 6th week of intervention.</time_frame>
      <description>. The Amputee Mobility Predictor (AMP) analyses an amputee's movement with or without a prosthesis in order to determine their potential for ambulation. A rapid and simple to use assessment instrument called the Amputee Mobility Predictor (AMP) was used to estimate the functional condition of lower-limb amputees both with and without the use of a prosthesis. AMPPRO 0- 42 (47 if assistive device is included) and AMPPRO 0-38 (43 if assistive device is included). Higher scores indicate better mobility,</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Lower Limb Amputation Below Knee (Injury)</condition>
    <arm_group>
      <arm_group_label>Phantom Exercises</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The phantom exercises involved visualizing and then trying to perform the movements of the phantom limb.&#xD;
  Place the limb at the angle at which they were sensing their phantom limb.&#xD;
  Put their healthy limb in the identical spot as they perceived their phantom limb.&#xD;
  Move their two limbs in opposition to one another.&#xD;
  Go back to where they started. The movements included ankle inversion and eversion, flexion and extension, and adduction and abduction with toe flexion and extension, respectively.&#xD;
  Once the patient is at ease, movements like hip or knee flexion/extension are performed until the PLP is gone.&#xD;
  Phantom exercises will be performed as many times as possible in a single session up to 15 times until the PLP fully subsided.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Prosthesis Training</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Training for prostheses at the appropriate amputation level will be provided. Conventional gait training protocols include Tandem walk, within parallel bar, controlled environment, full length Mirror on one side, weight shifting, shifting onto the Prosthetic Side, Pelvic rotation, Stepping on multiple heights and positions, Tandem walk, within parallel bar, and weight shifting. Gait training will last six weeks in total.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Prosthesis Training</intervention_name>
      <description>Training for prostheses at the appropriate amputation level will be provided. Conventional gait training protocols include Tandem walk, within parallel bar, controlled environment, full length Mirror on one side, weight shifting, shifting onto the Prosthetic Side, Pelvic 22 rotation, Stepping on multiple heights and positions, Tandem walk, within parallel bar, and weight shifting. Gait training will last six weeks in total.</description>
      <arm_group_label>Prosthesis Training</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Phantom Exercises</intervention_name>
      <description>The phantom exercises involved visualizing and then trying to perform the movements of the phantom limb.</description>
      <arm_group_label>Phantom Exercises</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age: 18-60 years&#xD;
  &#xD;
            2. Gender: male/female&#xD;
  &#xD;
            3. Unilateral lower limb amputees (trans-femoral, trans-tibial) and using prosthesis and&#xD;
               having phantom limb pain will be included.&#xD;
  &#xD;
            4. Limb deficiency and phantom limb questionnaire was used for screening of patients&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Severe systematic illness&#xD;
  &#xD;
            2. Psychological issues&#xD;
  &#xD;
            3. Hearing/ visual impairment&#xD;
  &#xD;
            4. Malignancies&#xD;
  &#xD;
            5. Infectious disease&#xD;
  &#xD;
            6. Neuropathic pain except PLP and residual limb pain&#xD;
  &#xD;
            7. Any disorder that restricts movement of opposed limb, limited range of motion in sound&#xD;
               limb&#xD;
  &#xD;
            8. Taking pain relief medications&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ashfaq Ahmad, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>The University of Lahore</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fiza Komal, MS</last_name>
      <phone>+923317681871</phone>
      <email>drfiza.komal@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ayesha Jamil, M.Phil</last_name>
      <phone>+923244481031</phone>
      <email>ayesha.jamil@uipt.uol.edu.pk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The University of Lahore</name>
        <address>
          <city>Lahore</city>
          <state>Punjab</state>
          <zip>5400</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Fiza Komal, MS</last_name>
        <phone>+923317681871</phone>
        <email>drfiza.komal@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Ayesha Jamil, M.Phil</last_name>
        <phone>+923244481031</phone>
        <email>ayesha.jamil@uipt.uol.edu.pk</email>
      </contact_backup>
      <investigator>
        <last_name>Fiza Komal, MS</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Phantom limb pain</keyword>
    <keyword>Prosthesis</keyword>
    <keyword>Prosthesis training</keyword>
    <keyword>Prosthesis satisfaction</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Participants data that underlies the results after de-identification</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>Immediately after publication</ipd_time_frame>
      <ipd_access_criteria>Researchers who provide methodological sound proposal</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/NCT06013631
  org study id: Fiza Komal
  nct id: NCT06013631
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The objective of the study is to assess the effects of prosthesis training with and without
        phantom exercises on pain, prosthesis satisfaction and ambulatory status of lower limb
        amputees treated with prosthesis training, phantom exercises and routine physical therapy.
  Amputation is a catastrophic incident in a person's life which resulted in psychological,
        social and physical consequences. Loss of extremity resulted in negative impact on patient's
        body and perception as well. Phantom limb pain (PLP) can be defined by discomfort or pain in
        lost part of limb experienced by lower limb amputees. Phantom limb pain is physically and
        mentally draining condition which affects patient's daily activities like personal care and
        functional independence.
  
        Phantom limb pain is highly prevalent condition among lower limb amputees. It is associated
        with negative effect on mental and physical health conditions. There are studies conducted on
        prosthesis training for prosthesis satisfaction.
  
        However, according to researcher knowledge effects of prosthesis training along with phantom
        exercises have not been measured on prosthesis satisfaction. This study will encourage future
        studies on this topic and will help in developing state of art treatment of phantom limb
        discomfort associated with lower limb subtraction. As managing phantom discomfort can result
        in better prosthesis satisfaction and eventually ease the ambulatory status of patient.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: The accessor will be unaware of treatment group.
  measure: Prosthesis satisfaction level
  time frame: It will be assessed at 6th week after the application of intervention.
  description: To check prosthesis satisfaction of the amputees, Trinity Amputation and Prosthesis Experience Scales (TAPES) will be used. It assesses prosthetic satisfaction on the basis of the functional, aesthetic, and weight subscales. TAPES evaluates how well people adjust to physical limitations that may have an impact on social behavior.Scores range from 5 to 25, with higher scores indicating greater levels of adjustment.
  measure: Phantom Limb Pain Intensity
  time frame: Pain intensity will be assessed at baseline and any change in pain intensity will be measured at 6th week of intervention.
  description: To check prosthesis satisfaction of the amputees, Trinity Amputation and Prosthesis Experience Scales (TAPES) will be used. It assesses prosthetic satisfaction on the basis of the functional, aesthetic, and weight subscales. TAPES evaluates how well people adjust to physical limitations that may have an impact on social behavior.
  visual analogue scale (VAS) can be used to aid someone to assess the strength of particular moods and experiences, such as pain. The visual analogue scale for pain is a conventional, with the lowest likely discomfort at one end and no pain at the other.
  measure: Ambulation Status
  time frame: Ambulation status will be observed at baseline and any change will be assessed at 6th week of intervention.
  description: . The Amputee Mobility Predictor (AMP) analyses an amputee's movement with or without a prosthesis in order to determine their potential for ambulation. A rapid and simple to use assessment instrument called the Amputee Mobility Predictor (AMP) was used to estimate the functional condition of lower-limb amputees both with and without the use of a prosthesis. AMPPRO 0- 42 (47 if assistive device is included) and AMPPRO 0-38 (43 if assistive device is included). Higher scores indicate better mobility,
  arm group label: Phantom Exercises
  arm group type: Experimental
  description: The phantom exercises involved visualizing and then trying to perform the movements of the phantom limb.
  Place the limb at the angle at which they were sensing their phantom limb.
  Put their healthy limb in the identical spot as they perceived their phantom limb.
  Move their two limbs in opposition to one another.
  Go back to where they started. The movements included ankle inversion and eversion, flexion and extension, and adduction and abduction with toe flexion and extension, respectively.
  Once the patient is at ease, movements like hip or knee flexion/extension are performed until the PLP is gone.
  Phantom exercises will be performed as many times as possible in a single session up to 15 times until the PLP fully subsided.
  arm group label: Prosthesis Training
  arm group type: Active Comparator
  description: Training for prostheses at the appropriate amputation level will be provided. Conventional gait training protocols include Tandem walk, within parallel bar, controlled environment, full length Mirror on one side, weight shifting, shifting onto the Prosthetic Side, Pelvic rotation, Stepping on multiple heights and positions, Tandem walk, within parallel bar, and weight shifting. Gait training will last six weeks in total.
  intervention type: Other
  intervention name: Prosthesis Training
  description: Training for prostheses at the appropriate amputation level will be provided. Conventional gait training protocols include Tandem walk, within parallel bar, controlled environment, full length Mirror on one side, weight shifting, shifting onto the Prosthetic Side, Pelvic 22 rotation, Stepping on multiple heights and positions, Tandem walk, within parallel bar, and weight shifting. Gait training will last six weeks in total.
  arm group label: Prosthesis Training
  intervention type: Other
  intervention name: Phantom Exercises
  description: The phantom exercises involved visualizing and then trying to perform the movements of the phantom limb.
  arm group label: Phantom Exercises
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Ashfaq Ahmad, PhD
  role: Study Chair
  affiliation: The University of Lahore
  last name: Fiza Komal, MS
  phone: +923317681871
  email: drfiza.komal@gmail.com
  last name: Ayesha Jamil, M.Phil
  phone: +923244481031
  email: ayesha.jamil@uipt.uol.edu.pk
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Pakistan
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: Participants data that underlies the results after de-identification
  ipd info type: Study Protocol
  ipd time frame: Immediately after publication
  ipd access criteria: Researchers who provide methodological sound proposal