Clinical trial NCT01715662: A Pilot RCT to Investigate the Use of a Home-based Nintendo Wii Program for Rehabilitation in Older Adults With Lower Limb Amputation
Official title: WiiHOME-AMPS: A Pilot Randomized Controlled Trial to Investigate the Use of a Home-based Nintendo Wii Program for Rehabilitation in Older Adults With a Unilateral Transtibial or Transfemoral Amputation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Limb Amputation
Keywords: rehabilitation
lower limb amputation
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: 2012-10-29
Enrollment: 28
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Change in Two Minute Walk Test
timeFrame: Baseline, end of treatment, 3 weeks post treatment
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: Baseline, end of treatment, 3 weeks post treatment
measure: The Physical Activity Scale for the Elderly (PASE)
timeFrame: Baseline, end of treatment, 3 weeks post treatment
measure: Walking While Talking Test
timeFrame: Baseline, end of treatment, 3 weeks post treatment
measure: Activities-specific Balance Confidence scale (ABC)
timeFrame: Baseline, end of treatment, 3 weeks post treatment
measure: Modus Health StepwatchTM Activity Monitor (SAM)
timeFrame: Baseline, end of treatment, 3 weeks post treatment
measure: Locomotor Capabilities Index in Amputees (LCI-5)
timeFrame: Baseline, end of treatment, 3 weeks post treatment
Other outcomes:
measure: Feasibility indicators
timeFrame: Throughout and at the end of study
Locations:
city: Vancouver
country: Canada
facility: Holy Family Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: GF Strong
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: William C. Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References: