<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/NCT01715662</url>
  </required_header>
  <id_info>
    <org_study_id>H11-01246</org_study_id>
    <nct_id>NCT01715662</nct_id>
  </id_info>
  <brief_title>A Pilot RCT to Investigate the Use of a Home-based Nintendo Wii Program for Rehabilitation in Older Adults With Lower Limb Amputation</brief_title>
  <official_title>WiiHOME-AMPS: A Pilot Randomized Controlled Trial to Investigate the Use of a Home-based Nintendo Wii Program for Rehabilitation in Older Adults With a Unilateral Transtibial or Transfemoral Amputation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot randomized controlled trial to assess the feasibility of a home-based&#xD;
      Nintendo Wii Fit program (Wii.n.Walk) to improve walking capacity in older adults with a&#xD;
      lower limb amputation. Twenty four individuals with a unilateral below-knee or above-knee&#xD;
      amputation will be randomly allocated to Wii.n.Walk or control arm. The Wii.n.Walk arm will&#xD;
      receive aerobics, weight-shifting, balance games and exercises using the Wii Fit gaming&#xD;
      technology. The control arm will receive cognitive computer games and exercises using Wii Big&#xD;
      Brain Academy Degree program. Both groups will receive the intervention for 40-minute&#xD;
      sessions, 3x/week for 4 weeks. The interventions will be conducted in combinations of&#xD;
      in-clinic group (n=3) training and individualized in-home training. Outcome measurements will&#xD;
      be completed by a blinded evaluator at baseline, end of treatment, and 3 weeks after the end&#xD;
      of treatment.&#xD;
&#xD;
      Hypothesis: Our primary hypothesis is that Wii.n.Walk is feasible. Our primary clinical&#xD;
      hypothesis is that participants in the Wii.n.Walk intervention group will experience an&#xD;
      improvement in walking capacity compared to the control group. The secondary clinical&#xD;
      hypothesis is that participants in the Wii.n.Walk group will experience an improvement in&#xD;
      balance confidence, physical activity, number of steps taken per day, walking while talking,&#xD;
      lower limb functioning, and locomotor capabilities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose: To assess the feasibility a home-based Nintendo Wii Fit program (Wii.n.Walk) in&#xD;
      improving walking capacity in older adults with a unilateral transtibial or transfemoral&#xD;
      amputation. This study will provide seed data and information (e.g. sample size calculation)&#xD;
      to leverage funds for a future RCT.&#xD;
&#xD;
      Hypothesis: Our primary hypothesis is that Wii.n.Walk is feasible. Our primary clinical&#xD;
      hypothesis is that participants in the Wii.n.Walk intervention group will experience an&#xD;
      improvement in walking capacity compared to the control group. The secondary clinical&#xD;
      hypothesis is that participants in the Wii.n.Walk group will experience an improvement in&#xD;
      balance confidence, physical activity, number of steps taken per day, walking while talking,&#xD;
      lower limb functioning, and locomotor capabilities.&#xD;
&#xD;
      Justification: Many older Canadians are living with lower limb amputation (LLA). The&#xD;
      prevalence of LLA is projected to double by 2050 primarily due to chronic systemic&#xD;
      dysvascular diseases that are common with aging. Prosthetic rehabilitation programs are&#xD;
      designed to enhance mobility primarily through gait retraining. An ideal rehabilitation&#xD;
      program optimizes balance and lower limb strength which in turn enhance walking capacity&#xD;
      which is an important determinant of health related quality of life in adults with LLA.&#xD;
      Providing a rehabilitation program that is motivating and engaging is challenging because&#xD;
      improvement requires highly repetitious task performance. In 1994-97, the cost of surgery,&#xD;
      rehabilitation and one year follow up post LLAs varied between $86,000 to $110,000 (US)&#xD;
      depending on the level of amputation. Shrinking health care resources often make it difficult&#xD;
      to deliver sufficient amount of therapy to achieve standard of care, and impossible to&#xD;
      deliver more therapy. Thus, novel methods which are practical, cost-effective, and&#xD;
      well-received by clients are needed to deliver sufficient amounts of therapy. Commercially&#xD;
      available gaming software such as the Wii Fit by Nintendo has the potential to be a valuable&#xD;
      intervention for older adults with LLA. Based on pilot single subject research design study&#xD;
      we have conducted we developed Wii.n.Walk, a home oriented intervention targeted to improve&#xD;
      walking capacity in individuals with LLA.&#xD;
&#xD;
      Objectives: The objective of this study is to assess the feasibility of Wii.n.Walk:&#xD;
      recruitment rate, consent rate, retention, perceived benefit from the intervention,&#xD;
      adherence, blinding, adverse events, safety, and treatment effect.&#xD;
&#xD;
      Research Method: This is a parallel, single-blind RCT. Twenty four individuals with a&#xD;
      unilateral transtibial or transfemoral will be randomly assigned to either the Wii.n.Walk, or&#xD;
      the Wii Big Brain (12 in each arm) using computer-generated block randomization. The&#xD;
      randomization will be done by a statistician who will not be involved in any part the study.&#xD;
&#xD;
      Subjects (n=12) in the Wii.n.Walk arm will be trained using the Wii Fit games for 40-minute&#xD;
      sessions, 3 times a week for a period of 4 weeks. Subjects will stand on the Wii Fit balance&#xD;
      board and interact with the Wii games through weight shifting or using the Wii remote&#xD;
      controller. The intervention protocol includes: 1) Yoga (static single and double leg&#xD;
      exercises), 2) Balance games (lateral and poster/anterior weight shifting exercises in&#xD;
      standing), 3) Aerobics (running on spot and step class), and 4) Strength training (dynamic&#xD;
      single and double leg exercises). For the in-clinic training sessions, a trained research&#xD;
      assistant will administer the intervention and will provide external cueing and correction of&#xD;
      the pose if the participants use unsafe technique.&#xD;
&#xD;
      Subjects (n=12) in the control arm will be trained using Wii Big Brain program for the same&#xD;
      frequency and duration as the Wii.n.Walk arm. A separate research assistant will administer&#xD;
      the intervention and will provide supervision. Wii Big Brain is a low-cost commercially&#xD;
      available gaming software to improve cognitive function.&#xD;
&#xD;
      The interventions will be conducted in combination of in-clinic group training (n=3) and&#xD;
      in-home individualized training.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">February 2014</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>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Two Minute Walk Test</measure>
    <time_frame>Baseline, end of treatment, 3 weeks post treatment</time_frame>
    <description>The Two Minute Walk Test (2MWT) will be used to measure walking capacity. Starting from a standing position, participants will be asked to walk as far as they can in a safe manner for two minutes over an indoor 80-meter flat out course.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Short Physical Performance Battery (SPPB)</measure>
    <time_frame>Baseline, end of treatment, 3 weeks post treatment</time_frame>
    <description>Short Physical Performance Battery (SPPB) will be used to measure subjects' lower extremity function by scoring their ability to perform four tasks: double-leg standing balance (feet together, semi-tandem, tandem), gait speed over 4 meters, and lower extremity strength (5x chair stands). Each task is scored from 0 (poor) to 4 (excellent). A total score will be generated by adding up the scores for individual tasks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Physical Activity Scale for the Elderly (PASE)</measure>
    <time_frame>Baseline, end of treatment, 3 weeks post treatment</time_frame>
    <description>The Physical Activity Scale for the Eldery (PASE) is a self-report measure that captures information on the frequency, duration, and intensity of various physical activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking While Talking Test</measure>
    <time_frame>Baseline, end of treatment, 3 weeks post treatment</time_frame>
    <description>Walking While Talking Test is a test of divided attention while locomotion. Subjects will be timed walking a 40 feet course twice while: 1) reciting the letters of the alphabet (a, b, c, ...) aloud (WWT-simple), and 2) reciting the alternate letters of the alphabet (a, c, e, …) aloud (WWT-complex). Subjects will be asked to pay attention to both walking and talking. The WWT outcomes will include total time, total numbers of alternate letters correctly recited and the total errors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activities-specific Balance Confidence scale (ABC)</measure>
    <time_frame>Baseline, end of treatment, 3 weeks post treatment</time_frame>
    <description>The 16-item Activities-specific Balance Confidence scale (ABC) will be used to assess self-efficacy associated with confidence to perform specific tasks without losing balance. Subjects report their confidence level on a scale of 0-100%. The individual item scores are summed and divided by 16 to derive a mean overall score with higher scores indicating higher confidence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modus Health StepwatchTM Activity Monitor (SAM)</measure>
    <time_frame>Baseline, end of treatment, 3 weeks post treatment</time_frame>
    <description>Modus Health StepwatchTM Activity Monitor (SAM) will be mounted on the prosthetic ankle to record number of steps taken per day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Locomotor Capabilities Index in Amputees (LCI-5)</measure>
    <time_frame>Baseline, end of treatment, 3 weeks post treatment</time_frame>
    <description>Locomotor Capabilities Index in Amputees (LCI-5) is a subjective scale designed for people with lower limb amputation. It is composed of 14 items that ask questions about subject's ability to perform different locomotor activities with their prosthesis on. Items are scored on a 5-level ordinal scale from 0 (not able) to 4 (able to accomplish the activity alone without ambulation aids). The total score ranges from 0 to 56, with higher scores indicating greater locomotor capabilities with the prosthesis and less dependence on assistance.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Feasibility indicators</measure>
    <time_frame>Throughout and at the end of study</time_frame>
    <description>Recruitment rate, consent rate, retention, participants' perceived benefit about the intervention, adherence, subject processing, blinding, adverse event, safety and treatment effect.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Lower Limb Amputation</condition>
  <arm_group>
    <arm_group_label>Wii.n.Walk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects (n=12) in the experimental arm (Wii.n.Walk) will be trained using the Wii Fit for 40-minute sessions, 3 times a week for a period of 4 weeks. Subjects will stand on the Wii Fit balance board and interact with the games through weight shifting or using the Wii remote controller. The intervention protocol includes: 1) Yoga (static single and double leg exercises), 2) Balance games (lateral and poster/anterior weight shifting exercises in standing), 3) Aerobics (running on spot and step class), and 4) Strength training (dynamic single and double leg exercises). The sessions will start in the clinic with a group of 3 participants and will graduate to individualized in-home training starting from week 2. For the in-clinic training sessions, a trained research assistant will administer the intervention and will provide external cueing and correction of the pose if the participants use unsafe technique.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects (n=12) in the control arm will play cognitive computer games using Wii Big Brain for the same frequency and duration as the Wii.n.Walk arm. The sessions will start in the clinic with a group of 3 participants and will graduate to individualized in-home training starting from week 2. For the in-clinic sessions, a research assistant will administer the intervention and will provide supervision. Wii Big Brain is a low-cost commercially available gaming software to improve cognitive function.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Wii.n.Walk</intervention_name>
    <description>Subjects will be trained using Nintendo Wii Fit (commercial fitness gaming software) for 40-minute sessions, 3x/week for 4 weeks. The intervention will initially be conducted in the clinic with a group of 3 participants and will graduate to in-home sessions starting from week 2.</description>
    <arm_group_label>Wii.n.Walk</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Wii Big Brain</intervention_name>
    <description>Subjects in the control group will be trained using Wii Big Brain Academy Degree program which is a low-cost commercially available gaming software to improve cognitive function. The intervention will initially be conducted in the clinic with a group of 3 participants and will graduate to in-home sessions starting from week 2.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  at least 1 year post a unilateral transtibial or transfemoral amputation&#xD;
&#xD;
          -  50 years of age or older&#xD;
&#xD;
          -  have been using a prosthesis for at least 2 hours per day for the past 6 months&#xD;
&#xD;
          -  currently not participating in another formal exercise or training program.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not able to provide an informed consent form&#xD;
&#xD;
          -  not able to communicate in English&#xD;
&#xD;
          -  has significant medical conditions (e.g. congestive heart failure) that&#xD;
             contraindicates participation in exercise program&#xD;
&#xD;
          -  had prosthetic socket fit issues (scores &lt;6 on the Prosthetic Socket Fit Comfort&#xD;
             Scale).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William C. Miller, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Holy Family Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5P 3L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GF Strong</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 2G9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Paul's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z 1Y6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>May 25, 2018</last_update_submitted>
  <last_update_submitted_qc>May 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>William C. Miller</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>rehabilitation</keyword>
  <keyword>lower limb amputation</keyword>
  <keyword>unilateral transtibial amputation</keyword>
  <keyword>unilateral transfemoral amputation</keyword>
  <keyword>older adults</keyword>
  <keyword>cognitive computer games</keyword>
  <keyword>home-based training</keyword>
  <keyword>Nintendo Wii</keyword>
  <keyword>virtual reality</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT01715662
org study id: H11-01246
nct id: NCT01715662
lead sponsor: 
has dmc: No
This is a pilot randomized controlled trial to assess the feasibility of a home-based
      Nintendo Wii Fit program (Wii.n.Walk) to improve walking capacity in older adults with a
      lower limb amputation. Twenty four individuals with a unilateral below-knee or above-knee
      amputation will be randomly allocated to Wii.n.Walk or control arm. The Wii.n.Walk arm will
      receive aerobics, weight-shifting, balance games and exercises using the Wii Fit gaming
      technology. The control arm will receive cognitive computer games and exercises using Wii Big
      Brain Academy Degree program. Both groups will receive the intervention for 40-minute
      sessions, 3x/week for 4 weeks. The interventions will be conducted in combinations of
      in-clinic group (n=3) training and individualized in-home training. Outcome measurements will
      be completed by a blinded evaluator at baseline, end of treatment, and 3 weeks after the end
      of treatment.

      Hypothesis: Our primary hypothesis is that Wii.n.Walk is feasible. Our primary clinical
      hypothesis is that participants in the Wii.n.Walk intervention group will experience an
      improvement in walking capacity compared to the control group. The secondary clinical
      hypothesis is that participants in the Wii.n.Walk group will experience an improvement in
      balance confidence, physical activity, number of steps taken per day, walking while talking,
      lower limb functioning, and locomotor capabilities.
Purpose: To assess the feasibility a home-based Nintendo Wii Fit program (Wii.n.Walk) in
      improving walking capacity in older adults with a unilateral transtibial or transfemoral
      amputation. This study will provide seed data and information (e.g. sample size calculation)
      to leverage funds for a future RCT.

      Hypothesis: Our primary hypothesis is that Wii.n.Walk is feasible. Our primary clinical
      hypothesis is that participants in the Wii.n.Walk intervention group will experience an
      improvement in walking capacity compared to the control group. The secondary clinical
      hypothesis is that participants in the Wii.n.Walk group will experience an improvement in
      balance confidence, physical activity, number of steps taken per day, walking while talking,
      lower limb functioning, and locomotor capabilities.

      Justification: Many older Canadians are living with lower limb amputation (LLA). The
      prevalence of LLA is projected to double by 2050 primarily due to chronic systemic
      dysvascular diseases that are common with aging. Prosthetic rehabilitation programs are
      designed to enhance mobility primarily through gait retraining. An ideal rehabilitation
      program optimizes balance and lower limb strength which in turn enhance walking capacity
      which is an important determinant of health related quality of life in adults with LLA.
      Providing a rehabilitation program that is motivating and engaging is challenging because
      improvement requires highly repetitious task performance. In 1994-97, the cost of surgery,
      rehabilitation and one year follow up post LLAs varied between $86,000 to $110,000 (US)
      depending on the level of amputation. Shrinking health care resources often make it difficult
      to deliver sufficient amount of therapy to achieve standard of care, and impossible to
      deliver more therapy. Thus, novel methods which are practical, cost-effective, and
      well-received by clients are needed to deliver sufficient amounts of therapy. Commercially
      available gaming software such as the Wii Fit by Nintendo has the potential to be a valuable
      intervention for older adults with LLA. Based on pilot single subject research design study
      we have conducted we developed Wii.n.Walk, a home oriented intervention targeted to improve
      walking capacity in individuals with LLA.

      Objectives: The objective of this study is to assess the feasibility of Wii.n.Walk:
      recruitment rate, consent rate, retention, perceived benefit from the intervention,
      adherence, blinding, adverse events, safety, and treatment effect.

      Research Method: This is a parallel, single-blind RCT. Twenty four individuals with a
      unilateral transtibial or transfemoral will be randomly assigned to either the Wii.n.Walk, or
      the Wii Big Brain (12 in each arm) using computer-generated block randomization. The
      randomization will be done by a statistician who will not be involved in any part the study.

      Subjects (n=12) in the Wii.n.Walk arm will be trained using the Wii Fit games for 40-minute
      sessions, 3 times a week for a period of 4 weeks. Subjects will stand on the Wii Fit balance
      board and interact with the Wii games through weight shifting or using the Wii remote
      controller. The intervention protocol includes: 1) Yoga (static single and double leg
      exercises), 2) Balance games (lateral and poster/anterior weight shifting exercises in
      standing), 3) Aerobics (running on spot and step class), and 4) Strength training (dynamic
      single and double leg exercises). For the in-clinic training sessions, a trained research
      assistant will administer the intervention and will provide external cueing and correction of
      the pose if the participants use unsafe technique.

      Subjects (n=12) in the control arm will be trained using Wii Big Brain program for the same
      frequency and duration as the Wii.n.Walk arm. A separate research assistant will administer
      the intervention and will provide supervision. Wii Big Brain is a low-cost commercially
      available gaming software to improve cognitive function.

      The interventions will be conducted in combination of in-clinic group training (n=3) and
      in-home individualized training.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Two Minute Walk Test
time frame: Baseline, end of treatment, 3 weeks post treatment
description: The Two Minute Walk Test (2MWT) will be used to measure walking capacity. Starting from a standing position, participants will be asked to walk as far as they can in a safe manner for two minutes over an indoor 80-meter flat out course.
measure: Short Physical Performance Battery (SPPB)
time frame: Baseline, end of treatment, 3 weeks post treatment
description: Short Physical Performance Battery (SPPB) will be used to measure subjects' lower extremity function by scoring their ability to perform four tasks: double-leg standing balance (feet together, semi-tandem, tandem), gait speed over 4 meters, and lower extremity strength (5x chair stands). Each task is scored from 0 (poor) to 4 (excellent). A total score will be generated by adding up the scores for individual tasks.
measure: The Physical Activity Scale for the Elderly (PASE)
time frame: Baseline, end of treatment, 3 weeks post treatment
description: The Physical Activity Scale for the Eldery (PASE) is a self-report measure that captures information on the frequency, duration, and intensity of various physical activities.
measure: Walking While Talking Test
time frame: Baseline, end of treatment, 3 weeks post treatment
description: Walking While Talking Test is a test of divided attention while locomotion. Subjects will be timed walking a 40 feet course twice while: 1) reciting the letters of the alphabet (a, b, c, ...) aloud (WWT-simple), and 2) reciting the alternate letters of the alphabet (a, c, e, …) aloud (WWT-complex). Subjects will be asked to pay attention to both walking and talking. The WWT outcomes will include total time, total numbers of alternate letters correctly recited and the total errors.
measure: Activities-specific Balance Confidence scale (ABC)
time frame: Baseline, end of treatment, 3 weeks post treatment
description: The 16-item Activities-specific Balance Confidence scale (ABC) will be used to assess self-efficacy associated with confidence to perform specific tasks without losing balance. Subjects report their confidence level on a scale of 0-100%. The individual item scores are summed and divided by 16 to derive a mean overall score with higher scores indicating higher confidence.
measure: Modus Health StepwatchTM Activity Monitor (SAM)
time frame: Baseline, end of treatment, 3 weeks post treatment
description: Modus Health StepwatchTM Activity Monitor (SAM) will be mounted on the prosthetic ankle to record number of steps taken per day.
measure: Locomotor Capabilities Index in Amputees (LCI-5)
time frame: Baseline, end of treatment, 3 weeks post treatment
description: Locomotor Capabilities Index in Amputees (LCI-5) is a subjective scale designed for people with lower limb amputation. It is composed of 14 items that ask questions about subject's ability to perform different locomotor activities with their prosthesis on. Items are scored on a 5-level ordinal scale from 0 (not able) to 4 (able to accomplish the activity alone without ambulation aids). The total score ranges from 0 to 56, with higher scores indicating greater locomotor capabilities with the prosthesis and less dependence on assistance.
measure: Feasibility indicators
time frame: Throughout and at the end of study
description: Recruitment rate, consent rate, retention, participants' perceived benefit about the intervention, adherence, subject processing, blinding, adverse event, safety and treatment effect.
arm group label: Wii.n.Walk
arm group type: Experimental
description: Subjects (n=12) in the experimental arm (Wii.n.Walk) will be trained using the Wii Fit for 40-minute sessions, 3 times a week for a period of 4 weeks. Subjects will stand on the Wii Fit balance board and interact with the games through weight shifting or using the Wii remote controller. The intervention protocol includes: 1) Yoga (static single and double leg exercises), 2) Balance games (lateral and poster/anterior weight shifting exercises in standing), 3) Aerobics (running on spot and step class), and 4) Strength training (dynamic single and double leg exercises). The sessions will start in the clinic with a group of 3 participants and will graduate to individualized in-home training starting from week 2. For the in-clinic training sessions, a trained research assistant will administer the intervention and will provide external cueing and correction of the pose if the participants use unsafe technique.
arm group label: Control
arm group type: Placebo Comparator
description: Subjects (n=12) in the control arm will play cognitive computer games using Wii Big Brain for the same frequency and duration as the Wii.n.Walk arm. The sessions will start in the clinic with a group of 3 participants and will graduate to individualized in-home training starting from week 2. For the in-clinic sessions, a research assistant will administer the intervention and will provide supervision. Wii Big Brain is a low-cost commercially available gaming software to improve cognitive function.
intervention type: Device
intervention name: Wii.n.Walk
description: Subjects will be trained using Nintendo Wii Fit (commercial fitness gaming software) for 40-minute sessions, 3x/week for 4 weeks. The intervention will initially be conducted in the clinic with a group of 3 participants and will graduate to in-home sessions starting from week 2.
arm group label: Wii.n.Walk
intervention type: Device
intervention name: Wii Big Brain
description: Subjects in the control group will be trained using Wii Big Brain Academy Degree program which is a low-cost commercially available gaming software to improve cognitive function. The intervention will initially be conducted in the clinic with a group of 3 participants and will graduate to in-home sessions starting from week 2.
arm group label: Control
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: William C. Miller, PhD
role: Principal Investigator
affiliation: University of British Columbia
facility: 
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: William C. Miller
investigator title: Principal Investigator