Lower Limb Amputation, Older Adults
Conditions
Keywords
Rehabilitation, Lower Limb Amputation, Prosthetic, Walking, unilateral transtibial amputation, unilateral transfemoral amputation, older adults, cognitive computer games, home-based training, Nintendo Wii, virtual reality
Brief summary
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.
Detailed description
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.
Interventions
DEVICENintendo Wii
Subjects will receive the intervention for 40-minute sessions, 3x/week for 4 weeks. The interventions will be administered in combination of onsite group training and individualized home-based training.
DEVICEWii Big Brain Academy Degree program
Subjects will receive the intervention for 40-minute sessions, 3x/week for 4 weeks. The interventions will be administered in combination of onsite group training and individualized home-based training.
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2 Minute Walk to assess walking speed and endurance improvement | 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 baseline | 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. |
| Change in two minute walk test from 1 month assessment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Activity Scale for the Elderly (PASE) | Follow-Up (3 weeks from post-intervention) | The Physical Activity Scale for the Elderly (PASE) is a self-report measure that captures information on the frequency, duration, and intensity of various physical activities. The 10 item PASE is generally partitioned into two parts. Part one, Leisure Time Activity, has six items that capture information about individual's involvement in daily activities such as participating in light exercise during the past seven days. The response options are never, seldom, sometimes, or often. Information on the type and the average time spent engaging in the activity per day is also captured. Part two, Household Activity, has three yes/no items which ask about participation in daily activities such as dusting or washing dishes over the past week. The last question asks about involvement in paid or volunteer work over the past week. The PASE also asks about the number of hours per week as well as the amount of physical activity involved for the job or volunteer work. |
| Change in Short Physical Performance Battery (SPPB) | Post Intervention (1 month from baseline) | Short Physical Performance Battery (SPPB) will be used to measure subjects' lower extremity function by scoring their ability to perform four tasks: double-leg standing balance (feet together, semi-tandem, tandem), single-leg standing balance, gait speed over 4 meters, and lower extremity strength (5x chair stands). Each task is scored from 0 (poor) to 4 (excellent). A total score will be generated by adding up the scores for individual tasks. We will look at overall and balance component scores. |
| Physical Activity Scale for the Elderly (PASE) | Baseline, Post Intervention (1 month after baseline), 3 week Follow-Up | The Physical Activity Scale for the Elderly (PASE) is a self-report measure that captures information on the frequency, duration, and intensity of various physical activities. The 10 item PASE is generally partitioned into two parts. Part one, Leisure Time Activity, has six items that capture information about individual's involvement in daily activities such as participating in light exercise during the past seven days. The response options are never, seldom, sometimes, or often. Information on the type and the average time spent engaging in the activity per day is also captured. Part two, Household Activity, has three yes/no items which ask about participation in daily activities such as dusting or washing dishes over the past week. The last question asks about involvement in paid or volunteer work over the past week. The PASE also asks about the number of hours per week as well as the amount of physical activity involved for the job or volunteer work. |
| Four Square Step Test (FSST) | Baseline, Post Intervention (1 month after baseline), 3 week Follow-Up | The Four Square Step Test (FSST) will measure dynamic standing balance. Four canes are placed on the floor to create 4 squares. The subject will step in each square as fast as possible and with use of his/her walking aid if needed. At the end of the test, the subject would have moved forward, backward, left and right while stepping over low objects. It also involves multiple transfer of weight between feet while changing direction. This test is timed and faster times indicate better dynamic standing balance. |
| Change in Short Physical Performance Battery from Post-Intervention | Follow-Up (3 weeks from post intervention) | Short Physical Performance Battery (SPPB) will be used to measure subjects' lower extremity function by scoring their ability to perform four tasks: double-leg standing balance (feet together, semi-tandem, tandem), single-leg standing balance, gait speed over 4 meters, and lower extremity strength (5x chair stands). Each task is scored from 0 (poor) to 4 (excellent). A total score will be generated by adding up the scores for individual tasks. We will look at overall and balance component scores. |
| Short Physical Performance Battery (SPPB) ability | Baseline | Short Physical Performance Battery (SPPB) will be used to measure subjects' lower extremity function by scoring their ability to perform four tasks: double-leg standing balance (feet together, semi-tandem, tandem), single-leg standing balance, gait speed over 4 meters, and lower extremity strength (5x chair stands). Each task is scored from 0 (poor) to 4 (excellent). A total score will be generated by adding up the scores for individual tasks. We will look at overall and balance component scores. |
| Change in Physical Activity Scale of the Elderly (PASE) | Post-Intervention (1 month from baseline) | The Physical Activity Scale for the Elderly (PASE) is a self-report measure that captures information on the frequency, duration, and intensity of various physical activities. The 10 item PASE is generally partitioned into two parts. Part one, Leisure Time Activity, has six items that capture information about individual's involvement in daily activities such as participating in light exercise during the past seven days. The response options are never, seldom, sometimes, or often. Information on the type and the average time spent engaging in the activity per day is also captured. Part two, Household Activity, has three yes/no items which ask about participation in daily activities such as dusting or washing dishes over the past week. The last question asks about involvement in paid or volunteer work over the past week. The PASE also asks about the number of hours per week as well as the amount of physical activity involved for the job or volunteer work. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Health Utility Index (HUI3) | Follow-Up (3 weeks from Post-Intervention) | The HUI3 is a brief questionnaire that asks subjects about their health status. |
| Change in Locomotor Capabilities Index in Amputees from Baseline | Post-Intervention (one month from baseline) | This is composed of 14 items that ask questions about subject's ability to perform different locomotor activities with their prosthesis on. Items are scored on a 5-level ordinal scale from 0 (not able) to 4 (able to accomplish the activity alone without ambulation aids). The total score ranges from 0 to 56, with higher scores indicating greater locomotor capabilities with the prosthesis and less dependence on assistance. |
| Change in Locomotor Capabilities Index in Amputees from Post-Intervention | Follow-Up (3 weeks from Post-Intervention) | This is composed of 14 items that ask questions about subject's ability to perform different locomotor activities with their prosthesis on. Items are scored on a 5-level ordinal scale from 0 (not able) to 4 (able to accomplish the activity alone without ambulation aids). The total score ranges from 0 to 56, with higher scores indicating greater locomotor capabilities with the prosthesis and less dependence on assistance. |
| Life Space Assessment (LSA) | Baseline | The Life Space Assessment is a five-item questionnaire that will be used to measure the size of the spatial area that subjects move in their daily life, as well as the frequency of their mobility within a certain time frame. |
| Change in Walking While Talking test from Post-intervention | Follow-Up (3 weeks from Post-intervention) | Subjects walk flat 20 feet (six metres) on a flat course, turn around, and walk 20 feet back to the start while reciting the letters of the alphabet (a, b, c, ...) aloud. They repeat this routine while reciting alternate letters of the alphabet (a, c, e, …) aloud. Subjects will be asked to pay attention to both walking and talking. The difference in time (to the nearest second) to complete the simple and complex walks is calculated with higher differences suggesting poorer ability to cope with dual tasks (e.g., greater need to focus on walking). |
| Qualitative Interviews | 1 month post-intervention | We will be conducting optional qualitative interviews with participants from the Vancouver site. The purpose of the qualitative interviews is to learn more about their personal experiences using either the brain or physical activity video game-based training programs. |
| Change in Walking While Talking Test from baseline | Post-Intervention (1 month from baseline) | Subjects walk flat 20 feet (six metres) on a flat course, turn around, and walk 20 feet back to the start while reciting the letters of the alphabet (a, b, c, ...) aloud. They repeat this routine while reciting alternate letters of the alphabet (a, c, e, …) aloud. Subjects will be asked to pay attention to both walking and talking. The difference in time (to the nearest second) to complete the simple and complex walks is calculated with higher differences suggesting poorer ability to cope with dual tasks (e.g., greater need to focus on walking). |
| StepwatchTM Activity Monitor (SAM) | Baseline | Activity Monitor (SAM) will be mounted on the ankle of prosthetic limb to monitor and record information regarding the number of steps per time interval to indicate the amount of physical activity performed in the community. |
| Health Utility Index (HUI3) | Baseline | The HUI3 is a brief questionnaire that asks subjects about their health status. |
| Walking While Talking Test | Baseline | Subjects walk flat 20 feet (six metres) on a flat course, turn around, and walk 20 feet back to the start while reciting the letters of the alphabet (a, b, c, ...) aloud. They repeat this routine while reciting alternate letters of the alphabet (a, c, e, …) aloud. Subjects will be asked to pay attention to both walking and talking. The difference in time (to the nearest second) to complete the simple and complex walks is calculated with higher differences suggesting poorer ability to cope with dual tasks (e.g., greater need to focus on walking). |
| Locomotor Capabilities Index in Amputees | Baseline | This is composed of 14 items that ask questions about subject's ability to perform different locomotor activities with their prosthesis on. Items are scored on a 5-level ordinal scale from 0 (not able) to 4 (able to accomplish the activity alone without ambulation aids). The total score ranges from 0 to 56, with higher scores indicating greater locomotor capabilities with the prosthesis and less dependence on assistance. |
| Fall Calendar | Baseline | This will be used to document the number of falls, circumstances (eg: cause, location, assistive device used or not) and consequences subject have had (eg/ medical visit, injury) over the course of study. |
| Change in Life Space Assessment from Baseline | Post Intervention (1 month from Baseline) | The Life Space Assessment is a five-item questionnaire that will be used to measure the size of the spatial area that subjects move in their daily life, as well as the frequency of their mobility within a certain time frame. |
| Change in Life Space Assessment from Post Intervention | Follow-Up (3 weeks from Post-Intervention) | The Life Space Assessment is a five-item questionnaire that will be used to measure the size of the spatial area that subjects move in their daily life, as well as the frequency of their mobility within a certain time frame. |
| Change in Fall calendar from Baseline | Post-Intervention (1 months from Baseline), Follow-Up (3 weeks from Post-Intervention), 62 weeks | This will be used to document the number of falls, circumstances (eg: cause, location, assistive device used or not) and consequences subject have had (eg/ medical visit, injury) over the course of study. |
| Change in Health Utility Index (HUI3)from baseline | Post-Intervention (1 month from baseline) | The HUI3 is a brief questionnaire that asks subjects about their health status. |
Countries
Canada
Outcome results
None listed