Older Adults Clinical Trial
— WiiNWalkOfficial title:
Evaluation of the WiiFit to Enhance Walking in Older Adults With Lower Limb Amputation
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 |
Verified date | October 2019 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
Canada,
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 |
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 |