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

NCT01715662 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2018-05-30

No results posted yet for this study

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.

Conditions

  • Lower Limb Amputation

Interventions

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.

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.

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • William C. Miller, PhD · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-02-28
Completion
2015-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01715662 on ClinicalTrials.gov