CompletedNot Applicable

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

Canada28 participantsStarted 2013-01

Plain-language summary

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.

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Two Minute Walk Test

Timeframe: Baseline, end of treatment, 3 weeks post treatment

Trial details

NCT IDNCT01715662

SponsorUniversity of British Columbia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-02

View on ClinicalTrials.gov More Lower Limb Amputation trials