A Pilot RCT to Investigate the Use of a Home-based Nintendo Wii Program for Rehabilitation in Older Adults With Lower Limb Amputation
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|ClinicalTrials.gov Identifier: NCT01715662|
Recruitment Status : Completed
First Posted : October 29, 2012
Last Update Posted : December 4, 2015
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 or disease||Intervention/treatment||Phase|
|Lower Limb Amputation||Device: Wii.n.Walk Device: Wii Big Brain||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||August 2015|
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.
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.
- Change in Two Minute Walk Test [ Time Frame: Baseline, end of treatment, 3 weeks post treatment ]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.
- Short Physical Performance Battery (SPPB) [ Time Frame: Baseline, end of treatment, 3 weeks post treatment ]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 ]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 ]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 ]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 ]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 ]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.
- Feasibility indicators [ Time Frame: Throughout and at the end of study ]Recruitment rate, consent rate, retention, participants' perceived benefit about the intervention, adherence, subject processing, blinding, adverse event, safety and treatment effect.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01715662
|Canada, British Columbia|
|Holy Family Hospital|
|Vancouver, British Columbia, Canada, V5P 3L6|
|Vancouver, British Columbia, Canada, V5Z 2G9|
|St. Paul's Hospital|
|Vancouver, British Columbia, Canada, V6Z 1Y6|
|Principal Investigator:||William C. Miller, PhD||University of British Columbia|