Study of WiiFit to Enhance Walking in Older Adult Amputees (WiiNWalk)

This study is not yet open for participant recruitment.
Verified March 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01942798
First received: August 27, 2013
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Older Adults With Lower Limb Amputations.
Device: Nintendo Wii

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the WiiFit to Enhance Walking in Older Adults With Lower Limb Amputation

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 2 Minute Walk to assess walking speed and endurance improvement [ Time Frame: Baseline, Post Intervention (1 month after baseline), 3 week Follow-Up ] [ Designated as safety issue: No ]
    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 [ Time Frame: Post-Intervention (1 month from Baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Follow-Up (3 weeks from post-intervention) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Physical Activity Scale for the Elderly (PASE) [ Time Frame: Baseline, Post Intervention (1 month after baseline), 3 week Follow-Up ] [ Designated as safety issue: No ]

    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.


  • Short Physical Performance Battery (SPPB) ability [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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) [ Time Frame: Post-Intervention (1 month from baseline) ] [ Designated as safety issue: No ]

    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 Physical Activity Scale for the Elderly (PASE) [ Time Frame: Follow-Up (3 weeks from post-intervention) ] [ Designated as safety issue: No ]

    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) [ Time Frame: Post Intervention (1 month from baseline) ] [ Designated as safety issue: No ]
    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 Short Physical Performance Battery from Post-Intervention [ Time Frame: Follow-Up (3 weeks from post intervention) ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Life Space Assessment (LSA) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • StepwatchTM Activity Monitor (SAM) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The HUI3 is a brief questionnaire that asks subjects about their health status.

  • Walking While Talking Test [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Post Intervention (1 month from Baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Follow-Up (3 weeks from Post-Intervention) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Post-Intervention (1 month from Baseline) ] [ Designated as safety issue: No ]
    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 Fall calendar from Post-Intervention [ Time Frame: Follow-Up (3 weeks from Post-Intervention) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Post-Intervention (1 month from baseline) ] [ Designated as safety issue: No ]
    The HUI3 is a brief questionnaire that asks subjects about their health status.

  • Change in Health Utility Index (HUI3) [ Time Frame: Follow-Up (3 weeks from Post-Interverntion) ] [ Designated as safety issue: No ]
    The HUI3 is a brief questionnaire that asks subjects about their health status.

  • Change in Locomotor Capabilities Index in Amputees from Baseline [ Time Frame: Post-Intervention (one month from baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Follow-Up (3 weeks from Post-Intervention) ] [ Designated as safety issue: No ]
    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 Walking While Talking Test from baseline [ Time Frame: Post-Intervention (1 month from baseline) ] [ Designated as safety issue: No ]
    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).

  • Change in Walking While Talking test from Post-intervention [ Time Frame: Follow-Up (3 weeks from Post-intervention) ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 72
Study Start Date: April 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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.

Experimental: 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.

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.

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01942798

Contacts
Contact: Bita Imam 604-714-4108 bita.imam@alumni.ubc.ca

Locations
Canada, British Columbia
GF Strong Rehabilitation Centre Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 2G9
Contact: Bita Imam, MA    604-714-4108    bita.imam@alumni.ubc.ca   
Contact: William C Miller, PhD    604-714-4107    bcmiller@telus.net   
Principal Investigator: William C Miller, PhD         
Sub-Investigator: Bita Imam, MA         
St. Paul's Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Bita Imam, MA    604-714-4108    bita.imam@alumni.ubc.ca   
Contact: William C Miller, PhD    604-714-4107    bcmiller@telus.net   
Principal Investigator: William C Miller, PhD         
Sub-Investigator: Bita Imam, MA         
Holy Family Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V5P 3L6
Contact: Bita Imam, MA    604-714-4108    bita.imam@alumni.ubc.ca   
Contact: William C Miller, PhD    604-417-4107    bcmiller@telus.net   
Principal Investigator: William C Miller, PhD         
Sub-Investigator: Bita Imam, MA         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: William C Miller University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01942798     History of Changes
Other Study ID Numbers: H13-01858
Study First Received: August 27, 2013
Last Updated: March 10, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Lower Limb Amputation
Prosthetic
Rehabilitation
Walking
unilateral transtibial amputation
unilateral transfemoral amputation
older adults
cognitive computer games
home-based training
Nintendo Wii
virtual reality

ClinicalTrials.gov processed this record on April 17, 2014