Study of WiiFit to Enhance Walking in Older Adult Amputees (NCT01942798) | Clinical Trial Compass
CompletedNot Applicable
Study of WiiFit to Enhance Walking in Older Adult Amputees
Canada72 participantsStarted 2014-04
Plain-language summary
WiiNWALK is a 4 week physical activity, with the intervention of a WiiFit, targeted to improve walking capacity in individuals with either a unilateral below-knee or above-knee amputation. This is a randomized control trial to evaluate the effectiveness of the WiiNWALK program in older (50+ years) community living adults with lower limb amputations (LLA).
Hypothesis: We expect the WiiNWALK intervention will have a treatment effect with improvement in functional walking capacity, compared to the control group who will only be playing cognitive games. Secondarily, a functional walking capacity will also include an improvement in lower extremity strength and balance, inter-limb gait symmetry, balance confidence along with participation in daily and social activities, locomotor capabilities and an increase in physical activities.
Who can participate
Age range
50 Years – 100 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:
* Subjects will be at least 50 years of age and have a unilateral TT or TF amputation
* Use their prosthesis for at least two hours per day for the past 6 months
* Be cognitively able to engage in the program
* Have a television that will enable connection to Nintendo hardware
Exclusion Criteria:
* Are unable to communicate in English
* Cannot provide informed consent
* Have important medical conditions
* Have prosthetic fit issues (ie: pain and discomfort)
* Are currently enrolled in another formal exercise or training program
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
1
2 Minute Walk to assess walking speed and endurance improvement
Timeframe: Baseline, Post Intervention (1 month after baseline), 3 week Follow-Up
2
Change in Two Minute Walk Test from baseline
Timeframe: Post-Intervention (1 month from Baseline)
3
Change in two minute walk test from 1 month assessment
Timeframe: Follow-Up (3 weeks from post-intervention)