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

NCT ID: NCT01715662

Last Updated: 2018-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-08-31

Brief 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.

Detailed Description

Purpose: To assess the feasibility a home-based Nintendo Wii Fit program (Wii.n.Walk) in improving walking capacity in older adults with a unilateral transtibial or transfemoral amputation. This study will provide seed data and information (e.g. sample size calculation) to leverage funds for a future RCT.

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.

Justification: Many older Canadians are living with lower limb amputation (LLA). The prevalence of LLA is projected to double by 2050 primarily due to chronic systemic dysvascular diseases that are common with aging. Prosthetic rehabilitation programs are designed to enhance mobility primarily through gait retraining. An ideal rehabilitation program optimizes balance and lower limb strength which in turn enhance walking capacity which is an important determinant of health related quality of life in adults with LLA. Providing a rehabilitation program that is motivating and engaging is challenging because improvement requires highly repetitious task performance. In 1994-97, the cost of surgery, rehabilitation and one year follow up post LLAs varied between $86,000 to $110,000 (US) depending on the level of amputation. Shrinking health care resources often make it difficult to deliver sufficient amount of therapy to achieve standard of care, and impossible to deliver more therapy. Thus, novel methods which are practical, cost-effective, and well-received by clients are needed to deliver sufficient amounts of therapy. Commercially available gaming software such as the Wii Fit by Nintendo has the potential to be a valuable intervention for older adults with LLA. Based on pilot single subject research design study we have conducted we developed Wii.n.Walk, a home oriented intervention targeted to improve walking capacity in individuals with LLA.

Objectives: The objective of this study is to assess the feasibility of Wii.n.Walk: recruitment rate, consent rate, retention, perceived benefit from the intervention, adherence, blinding, adverse events, safety, and treatment effect.

Research Method: This is a parallel, single-blind RCT. Twenty four individuals with a unilateral transtibial or transfemoral will be randomly assigned to either the Wii.n.Walk, or the Wii Big Brain (12 in each arm) using computer-generated block randomization. The randomization will be done by a statistician who will not be involved in any part the study.

Subjects (n=12) in the Wii.n.Walk arm will be trained using the Wii Fit games 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 Wii 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). 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 (n=12) in the control arm will be trained using Wii Big Brain program for the same frequency and duration as the Wii.n.Walk arm. A separate 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.

The interventions will be conducted in combination of in-clinic group training (n=3) and in-home individualized training.

Conditions

Lower Limb Amputation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Wii.n.Walk

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.

Group Type: EXPERIMENTAL

Wii.n.Walk

Intervention Type: DEVICE

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.

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.

Group Type: PLACEBO_COMPARATOR

Wii Big Brain

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

William C. Miller

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William C. Miller, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Holy Family Hospital

Vancouver, British Columbia, Canada

GF Strong

Vancouver, British Columbia, Canada

St. Paul's Hospital

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H11-01246

Identifier Type: -

Identifier Source: org_study_id