Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01942798
Other study ID # H13-01858
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04521374 - The Effects of Texture Modified Diets on Dietary Intake and Appetite Responses in Older Adults N/A
Completed NCT05039879 - Life Improving Factors After a Hip Fracture
Recruiting NCT05978336 - SuPA Mobility: Supporting Physical Activity for Mobility in Mobility-Limited Older Adults N/A
Completed NCT02905370 - Progressing Home Health Rehabilitation for Older Adults N/A
Not yet recruiting NCT06453473 - Transfer Effects of Stationary Bicycle Perturbation Training on Older Adults' Cycling Skills N/A
Completed NCT03039556 - Step-reduction in Older Men and Women N/A
Completed NCT05901506 - Strengthen Family Members' Understanding of Advance Care Planning With a Nurse-led, Motivational Interview N/A
Recruiting NCT06030128 - Core Stabilization Exercise Therapy in Chronic Lower Back Back Management in Community Dwelling Older Adults N/A
Completed NCT04044183 - Managing Pain and Cognitions in Older Adults With Mild Cognitive Impairment or Memory Related Problems and Chronic Pain N/A
Not yet recruiting NCT06323954 - tVNS During Motor Training in Older Adults N/A
Recruiting NCT05366075 - The Preventing Functional Decline in Acutely Hospitalized Older Patients (PREV_FUNC) Study Phase 3
Completed NCT05497960 - Vivo Prediabetes Study: Online, Live, and Interactive Strength Training for Older Adults With Prediabetes N/A
Recruiting NCT05083221 - Effect of an Aural Rehabilitation Program in Hearing-impaired Older Adults N/A
Completed NCT05397158 - Optimization of Intestinal Preparation in Older Patients N/A
Completed NCT05459103 - Remote Interactive Intervention for Loneliness N/A
Completed NCT05025137 - Flexi-Bar and Multi-Component Exercises N/A
Completed NCT04927026 - "Where-there-is-no-psychiatrist Integrated Personal Therapy" Among Community-Dwelling Older Adults N/A
Completed NCT03197038 - Exercise Training and Cognitive Function in Kidney Disease N/A
Recruiting NCT06302686 - engAGE: Managing cognitivE decliNe throuGh Theatre Therapy, Artificial Intelligence and Social Robots drivEn Interventions N/A
Not yet recruiting NCT05078008 - The Role of Balneotherapy in Older Adults With Chronic Low Back Pain N/A