Evaluation of the WiiFit to Enhance Walking in Older Adults With Lower Limb Amputation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 5
- 主要终点
- 2 Minute Walk to assess walking speed and endurance improvement
研究概览
简要总结
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.
详细描述
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.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cognitive Games
The Cognitive Games group will receive 40 minute supervised group training three times per week for a period of four weeks. The group for the first week will be held at the clinic, while the remaining three weeks be conducted at the subject's home and supervised by the Trainer remotely using a tablet with video conferencing capability. At the end of the four-week Supervised Phase, subjects will retain the Wii units and they will be encouraged to use the program on their own for an additional period of four weeks (Unsupervised Phase).
Subjects in the control group will play cognitive oriented video games using Wii Big Brain Academy Degree program. BigBrain™ is a video gaming system which has games and exercises to improve cognitive function(identify, memorize, analyze, compute, and visualize). Subjects use the Wii handheld remote to participate in the games by pointing and clicking the remote to select on-screen answers in response to on-screen questions.
干预措施: Wii Big Brain Academy Degree program (Device)
WiiNWALK Intervention
The intervention group will also receive 40 minute supervised group training three times per week for a period of four weeks. Interventions conducted over the first week will be held at the clinic, while the remaining three weeks be conducted at the subject's home and supervised by the Trainer remotely. At the end of the four-week Supervised Phase, subjects will retain the Wii units and they will be encouraged to use the program on their own for an additional period of four weeks (Unsupervised Phase).
The WiiNWALK protocol consists of performing Nintendo WiiFit activities. Subjects stand on the WiiFit balance board and interact with the WiiFit games through weight shifting or by using the Wii handheld remote control. The intervention protocol will include selected exercises consisting of: 1) Yoga 2) Balance Tasks 3) Strength training and 4) Aerobics.
At the in-clinic sessions in Vancouver, a motion-sensing device will also record video and skeleton data of the participant.
干预措施: Nintendo Wii (Device)
结局指标
主要结局
2 Minute Walk to assess walking speed and endurance improvement
时间窗: Baseline, Post Intervention (1 month after baseline), 3 week Follow-Up
Starting from a standing position, subjects are asked to walk as far as they can in a safe manner for two minutes over a flat out and back 80-metre course. The distance travelled to the nearest metre is recorded.
Change in two minute walk test from 1 month assessment
时间窗: Follow-Up (3 weeks from post-intervention)
Starting from a standing position, subjects are asked to walk as far as they can in a safe manner for two minutes over a flat out and back 80-metre course. The distance travelled to the nearest metre is recorded.
Change in Two Minute Walk Test from baseline
时间窗: Post-Intervention (1 month from Baseline)
To assess changes in the participant's walking speed and endurance, they will start from a standing position, subjects are asked to walk as far as they can in a safe manner for two minutes over a flat out and back 80-metre course. The distance traveled to the nearest meter is recorded.
次要结局
- Change in Short Physical Performance Battery from Post-Intervention(Follow-Up (3 weeks from post intervention))
- Four Square Step Test (FSST)(Baseline, Post Intervention (1 month after baseline), 3 week Follow-Up)
- Physical Activity Scale for the Elderly (PASE)(Baseline, Post Intervention (1 month after baseline), 3 week Follow-Up)
- Short Physical Performance Battery (SPPB) ability(Baseline)
- Change in Short Physical Performance Battery (SPPB)(Post Intervention (1 month from baseline))
- Change in Physical Activity Scale of the Elderly (PASE)(Post-Intervention (1 month from baseline))
- Change in Physical Activity Scale for the Elderly (PASE)(Follow-Up (3 weeks from post-intervention))
研究者
William C. Miller
Principal Investigator
University of British Columbia