Study of WiiFit to Enhance Walking in Older Adult Amputees

Older Adults Clinical Trial

— WiiNWalk  

Official title:

Evaluation of the WiiFit to Enhance Walking in Older Adults With Lower Limb Amputation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01942798
• Other study ID #: H13-01858
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: May 8, 2019

Study information

• Verified date: October 2019
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 8, 2019
• Est. primary completion date: May 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Lower Limb Amputation
• Older Adults

Intervention

Device:
• Nintendo 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.
• Wii 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.

Locations

Country	Name	City	State
Canada	Glenrose Rehabilitation Centre	Edmonton	Alberta
Canada	Parkwood Hospital	London	Ontario
Canada	GF Strong Rehabilitation Centre	Vancouver	British Columbia
Canada	Holy Family Hospital	Vancouver	British Columbia
Canada	St. Paul's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Life Space Assessment (LSA)	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.	Baseline
Other	StepwatchTM Activity Monitor (SAM)	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.	Baseline
Other	Health Utility Index (HUI3)	The HUI3 is a brief questionnaire that asks subjects about their health status.	Baseline
Other	Walking While Talking Test	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).	Baseline
Other	Locomotor Capabilities Index in Amputees	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.	Baseline
Other	Fall Calendar	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.	Baseline
Other	Change in Life Space Assessment 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.	Post Intervention (1 month from Baseline)
Other	Change in Life Space Assessment 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.	Follow-Up (3 weeks from Post-Intervention)
Other	Change in Fall calendar from 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.	Post-Intervention (1 months from Baseline), Follow-Up (3 weeks from Post-Intervention), 62 weeks
Other	Change in Health Utility Index (HUI3)from baseline	The HUI3 is a brief questionnaire that asks subjects about their health status.	Post-Intervention (1 month from baseline)
Other	Change in Health Utility Index (HUI3)	The HUI3 is a brief questionnaire that asks subjects about their health status.	Follow-Up (3 weeks from Post-Intervention)
Other	Change in Locomotor Capabilities Index in Amputees 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.	Post-Intervention (one month from baseline)
Other	Change in Locomotor Capabilities Index in Amputees 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.	Follow-Up (3 weeks from Post-Intervention)
Other	Change in Walking While Talking Test 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).	Post-Intervention (1 month from baseline)
Other	Change in Walking While Talking test 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).	Follow-Up (3 weeks from Post-intervention)
Other	Qualitative Interviews	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.	1 month post-intervention
Primary	2 Minute Walk to assess walking speed and endurance improvement	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.	Baseline, Post Intervention (1 month after baseline), 3 week Follow-Up
Primary	Change in Two Minute Walk Test 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.	Post-Intervention (1 month from Baseline)
Primary	Change in two minute walk test from 1 month assessment	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.	Follow-Up (3 weeks from post-intervention)
Secondary	Physical Activity Scale for the Elderly (PASE)	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.	Baseline, Post Intervention (1 month after baseline), 3 week Follow-Up
Secondary	Short Physical Performance Battery (SPPB) ability	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.	Baseline
Secondary	Change in Physical Activity Scale of the Elderly (PASE)	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.	Post-Intervention (1 month from baseline)
Secondary	Change in Physical Activity Scale for the Elderly (PASE)	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.	Follow-Up (3 weeks from post-intervention)
Secondary	Change in Short Physical Performance Battery (SPPB)	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.	Post Intervention (1 month from baseline)
Secondary	Change in Short Physical Performance Battery 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.	Follow-Up (3 weeks from post intervention)
Secondary	Four Square Step Test (FSST)	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.	Baseline, Post Intervention (1 month after baseline), 3 week Follow-Up