A Pilot RCT to Investigate the Use of a Home-based Nintendo Wii Program for Rehabilitation in Older Adults With Lower Limb Amputation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01715662
First received: October 15, 2012
Last updated: November 27, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Lower Limb Amputation
Device: Wii.n.Walk
Device: Wii Big Brain

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Change in Two Minute Walk Test [ Time Frame: Baseline, end of treatment, 3 weeks post treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Short Physical Performance Battery (SPPB) [ Time Frame: Baseline, end of treatment, 3 weeks post treatment ] [ Designated as safety issue: No ]
    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.

  • The Physical Activity Scale for the Elderly (PASE) [ Time Frame: Baseline, end of treatment, 3 weeks post treatment ] [ Designated as safety issue: No ]
    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.

  • Walking While Talking Test [ Time Frame: Baseline, end of treatment, 3 weeks post treatment ] [ Designated as safety issue: No ]
    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.

  • Activities-specific Balance Confidence scale (ABC) [ Time Frame: Baseline, end of treatment, 3 weeks post treatment ] [ Designated as safety issue: No ]
    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.

  • Modus Health StepwatchTM Activity Monitor (SAM) [ Time Frame: Baseline, end of treatment, 3 weeks post treatment ] [ Designated as safety issue: No ]
    Modus Health StepwatchTM Activity Monitor (SAM) will be mounted on the prosthetic ankle to record number of steps taken per day.

  • Locomotor Capabilities Index in Amputees (LCI-5) [ Time Frame: Baseline, end of treatment, 3 weeks post treatment ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Feasibility indicators [ Time Frame: Throughout and at the end of study ] [ Designated as safety issue: No ]
    Recruitment rate, consent rate, retention, participants' perceived benefit about the intervention, adherence, subject processing, blinding, adverse event, safety and treatment effect.


Estimated Enrollment: 24
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Wii.n.Walk
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.
Device: Wii.n.Walk
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.
Placebo Comparator: Control
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.
Device: Wii Big Brain
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • at least 1 year post a unilateral transtibial or transfemoral amputation
  • 50 years of age or older
  • have been using a prosthesis for at least 2 hours per day for the past 6 months
  • currently not participating in another formal exercise or training program.

Exclusion Criteria:

  • not able to provide an informed consent form
  • not able to communicate in English
  • has significant medical conditions (e.g. congestive heart failure) that contraindicates participation in exercise program
  • had prosthetic socket fit issues (scores <6 on the Prosthetic Socket Fit Comfort Scale).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715662

Locations
Canada, British Columbia
GF Strong
Vancouver, British Columbia, Canada, V5Z 2G9
Holy Family Hospital
Vancouver, British Columbia, Canada, V5P 3L6
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: William C. Miller, PhD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01715662     History of Changes
Other Study ID Numbers: H11-01246
Study First Received: October 15, 2012
Last Updated: November 27, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
rehabilitation
lower limb amputation
unilateral transtibial amputation
unilateral transfemoral amputation
older adults
cognitive computer games
home-based training
Nintendo Wii
virtual reality

ClinicalTrials.gov processed this record on March 26, 2015