Clinical trial NCT01942798: Study of WiiFit to Enhance Walking in Older Adult Amputees
Official title: Evaluation of the WiiFit to Enhance Walking in Older Adults With Lower Limb Amputation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Limb Amputation
Older Adults
Keywords: Rehabilitation
Lower Limb Amputation
Prosthetic
Walking
unilateral transtibial amputation
unilateral transfemoral amputation
older adults
cognitive computer games
home-based training
Nintendo Wii
virtual reality
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2013-09-16
Enrollment: 72
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Lower limb amputation (LLA) is prevalent among older Canadians. Estimates from 2003 suggest that \> 2 million individuals were living with LLA in North America with an annual estimated 150,000 incident cases. Over 50% of these procedures are considered major, with 28% of individuals having a transtibial (TT) or below knee amputation and 26% having a transfemoral (TF) or above knee amputation. The WiiNWalk is designed to evaluate whether this intervention does improve the walking capacity of older adults through a series of balancing and other physical activities using the Wii balance board.

An improved walking capacity (ie: being able to walk a longer distance) may effect balance, strength, and fitness components that are critical to improve prosthetic walking. The ability to walk a longer distance may effect a person's lifestyle as it allows the individual to move around his/her environment independently which in turn impacts ones choice of daily and social activities and participation, and therefore providing them with more mobility, freedom and choice.

This study focuses on older adults because, according to Canadian Institute of Health Information data, 50-74 year old were 17 times more likely to have a LLA and individuals aged ≥ 75 were 36 times more likely to have a LLA.The primary reason for this exponential age-related increased incidence is the late stage effects of chronic diseases such as diabetes and vascular disease that are common in older adults.

If as anticipated, the WiiFit proves to increase walking capacity, it will provide a low cost method for those with LLA to have an accessible system that, due to the weight-shifting, balance and aerobic training nature of the Wii games, will serve as a therapeutic agent for rehabilitation.

Eligibility criteria: 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

Primary outcomes:
measure: 2 Minute Walk to assess walking speed and endurance improvement
timeFrame: Baseline, Post Intervention (1 month after baseline), 3 week Follow-Up
measure: Change in Two Minute Walk Test from baseline
timeFrame: Post-Intervention (1 month from Baseline)
measure: Change in two minute walk test from 1 month assessment
timeFrame: Follow-Up (3 weeks from post-intervention)
Secondary outcomes:
measure: Physical Activity Scale for the Elderly (PASE)
timeFrame: Baseline, Post Intervention (1 month after baseline), 3 week Follow-Up
measure: Short Physical Performance Battery (SPPB) ability
timeFrame: Baseline
measure: Change in Physical Activity Scale of the Elderly (PASE)
timeFrame: Post-Intervention (1 month from baseline)
measure: Change in Physical Activity Scale for the Elderly (PASE)
timeFrame: Follow-Up (3 weeks from post-intervention)
measure: Change in Short Physical Performance Battery (SPPB)
timeFrame: Post Intervention (1 month from baseline)
measure: Change in Short Physical Performance Battery from Post-Intervention
timeFrame: Follow-Up (3 weeks from post intervention)
measure: Four Square Step Test (FSST)
timeFrame: Baseline, Post Intervention (1 month after baseline), 3 week Follow-Up
Other outcomes:
measure: Life Space Assessment (LSA)
timeFrame: Baseline
measure: StepwatchTM Activity Monitor (SAM)
timeFrame: Baseline
measure: Health Utility Index (HUI3)
timeFrame: Baseline
measure: Walking While Talking Test
timeFrame: Baseline
measure: Locomotor Capabilities Index in Amputees
timeFrame: Baseline
measure: Fall Calendar
timeFrame: Baseline
measure: Change in Life Space Assessment from Baseline
timeFrame: Post Intervention (1 month from Baseline)
measure: Change in Life Space Assessment from Post Intervention
timeFrame: Follow-Up (3 weeks from Post-Intervention)
measure: Change in Fall calendar from Baseline
timeFrame: Post-Intervention (1 months from Baseline), Follow-Up (3 weeks from Post-Intervention), 62 weeks
measure: Change in Health Utility Index (HUI3)from baseline
timeFrame: Post-Intervention (1 month from baseline)
measure: Change in Health Utility Index (HUI3)
timeFrame: Follow-Up (3 weeks from Post-Intervention)
measure: Change in Locomotor Capabilities Index in Amputees from Baseline
timeFrame: Post-Intervention (one month from baseline)
measure: Change in Locomotor Capabilities Index in Amputees from Post-Intervention
timeFrame: Follow-Up (3 weeks from Post-Intervention)
measure: Change in Walking While Talking Test from baseline
timeFrame: Post-Intervention (1 month from baseline)
measure: Change in Walking While Talking test from Post-intervention
timeFrame: Follow-Up (3 weeks from Post-intervention)
measure: Qualitative Interviews
timeFrame: 1 month post-intervention
Locations:
city: Edmonton
country: Canada
facility: Glenrose Rehabilitation Centre
state: Alberta
city: Vancouver
country: Canada
facility: Holy Family Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: GF Strong Rehabilitation Centre
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: London
country: Canada
facility: Parkwood Hospital
state: Ontario
Study officials:
affiliation: University of British Columbia
name: William C Miller
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tao G, Miller WC, Eng JJ, Esfandiari E, Imam B, Lindstrom H, Payne MW. Group-based telerehabilitation intervention using Wii Fit to improve walking in older adults with lower limb amputation (WiiNWalk): A randomized control trial. Clin Rehabil. 2022 Mar;36(3):331-341. doi: 10.1177/02692155211061222. Epub 2021 Nov 29.
citation: Imam B, Miller WC, Finlayson HC, Eng JJ, Payne MW, Jarus T, Goldsmith CH, Mitchell IM. A Telehealth Intervention Using Nintendo Wii Fit Balance Boards and iPads to Improve Walking in Older Adults With Lower Limb Amputation (Wii.n.Walk): Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2014 Dec 22;3(4):e80. doi: 10.2196/resprot.4031.