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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 6
- 主要终点
- Change in Two Minute Walk Test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Wii.n.Walk (Device)
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.
干预措施: Wii Big Brain (Device)
结局指标
主要结局
Change in Two Minute Walk Test
时间窗: Baseline, end of treatment, 3 weeks post treatment
The Two Minute Walk Test (2MWT) will be used to measure walking capacity. Starting from a standing position, participants will be asked to walk as far as they can in a safe manner for two minutes over an indoor 80-meter flat out course.
次要结局
- Activities-specific Balance Confidence scale (ABC)(Baseline, end of treatment, 3 weeks post treatment)
- Modus Health StepwatchTM Activity Monitor (SAM)(Baseline, end of treatment, 3 weeks post treatment)
- Locomotor Capabilities Index in Amputees (LCI-5)(Baseline, end of treatment, 3 weeks post treatment)
- Short Physical Performance Battery (SPPB)(Baseline, end of treatment, 3 weeks post treatment)
- The Physical Activity Scale for the Elderly (PASE)(Baseline, end of treatment, 3 weeks post treatment)
- Walking While Talking Test(Baseline, end of treatment, 3 weeks post treatment)
研究者
William C. Miller
Principal Investigator
University of British Columbia