A Pilot RCT to Investigate the Use of a Home-based Nintendo Wii Program for Rehabilitation in Older Adults With Lower Limb Amputation

This study is currently recruiting participants.
Verified January 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01715662
First received: October 15, 2012
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

This is a pilot randomized controlled trial to assess the feasibility of a home-based Nintendo Wii program in rehabilitation of individuals with a lower limb amputation. Twenty individuals with a unilateral below-knee or above-knee amputation will be randomly allocated to experimental or control arm. The experimental arm will receive weight-shifting and balance games and exercises using the Wii balance board. The control arm will receive cognitive computer games and exercises using Lumosity Brain Training program. Both groups 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. Outcome measurements will be done by a blinded evaluator at baseline, end of treatment, and 3 weeks after the end of treatment.

Hypothesis: Our guiding primary hypothesis is that the Wii will result in improved functional walking capacity of older adults with a mature (≥1 year post) unilateral transtibial or transfemoral amputation. Secondary hypotheses are that the Wii will lead to improvement in lower extremity strength and balance, inter-limb gait symmetry, balance confidence, participation in daily and social activities, locomotor capabilities, and increase in physical activities.


Condition Intervention
Lower Limb Amputation
Device: Nintendo Wii

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: WiiHOME-AMPS: A Pilot Randomized Controlled Trial to Investigate the Use of a Home-based Nintendo Wii Program for Rehabilitation in Older Adults With a Unilateral Transtibial or Transfemoral Amputation

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Change in 6-Minute Walk Test [ Time Frame: Baseline, end of treatment, 3 weeks post treatment ] [ Designated as safety issue: No ]
    The 6-Minute Walk Test will be employed to measure the functional walking capacity of subjects. Subjects will be instructed to walk as far as they can over an 80-meter course in 6 minutes. The distance covered in 6 minutes will be recorded.


Secondary Outcome Measures:
  • Short Physical Performance Battery (SPPB) [ Time Frame: Baseline, end of treatment, 3 weeks post treatment ] [ 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.

  • Inter-limb gait symmetry ratio [ Time Frame: Baseline, end of treatment, 3 weeks post treatment ] [ Designated as safety issue: No ]
    The inter-limb gait symmetry ratio will be measured by GAITRite walkway system. The GAITRite walkway system (CIR Systems Inc., Havertown, PA) is an electronic walkway carpet that quantifies the spatial and temporal parameters of footstep patterns of the subjects. As the subject ambulates along the walkway, the sensors embedded along the length of the carpet capture the gait pattern data. The carpet is connected to a computer where the gait parameters are calculated using software algorithms. The inter-limb gait symmetry ratio will be computed according to the following formula: [(non-prosthetic leg stance time/swing time) / (prosthetic leg stance time/swing time)]. A ratio of 1 represents a perfect inter-limb symmetry. The higher the score is above 1, the higher the gait asymmetry is toward the non-prosthetic leg (i.e. more load on non-prosthetic leg).

  • Walking While Talking Test [ Time Frame: Baseline, end of treatment, 3 weeks post treatment ] [ Designated as safety issue: No ]
    Walking While Talking Test is a test of divided attention while locomotion. Subjects will be timed walking a 40 feet course twice while: 1) reciting the letters of the alphabet (a, b, c, ...) aloud (WWT-simple), and 2) reciting the alternate letters of the alphabet (a, c, e, …) aloud (WWT-complex). Subjects will be asked to pay attention to both walking and talking. The WWT outcomes will include total time, total numbers of alternate letters correctly recited and the total errors.

  • Activities-specific Balance Confidence scale (ABC) [ Time Frame: Baseline, end of treatment, 3 weeks post treatment ] [ Designated as safety issue: No ]
    The 16-item Activities-specific Balance Confidence scale (ABC) will be used to assess self-efficacy associated with confidence to perform specific tasks without losing balance. Subjects report their confidence level on a scale of 0-100%. The individual item scores are summed and divided by 16 to derive a mean overall score with higher scores indicating higher confidence.

  • The Frenchay Activities Index (FAI) [ Time Frame: Baseline, end of treatment, 3 weeks post treatment ] [ Designated as safety issue: No ]
    The Frenchay Activities Index (FAI) captures information about daily and social activities by asking about the frequency with which individuals perform these activities. This 15-item questionnaire is partitioned into two parts: the first 10 items ask individuals to estimate the frequency of their participation in daily chores and activities such as preparing meals or washing clothes during the past three months. The next 5 items ask individuals to estimate their participation in other activities such as travelling, or gardening during the past six months. Response options range from 0 (never) to 3 (at least once a week). A summary score is derived by adding up the response of all items. The total score ranges from 0 (no participation) to 45 (frequent participation).

  • Locomotor Capabilities Index in Amputees (LCI-5) [ Time Frame: Baseline, end of treatment, 3 weeks post treatment ] [ Designated as safety issue: No ]
    Locomotor Capabilities Index in Amputees (LCI-5) is a subjective scale designed for people with lower limb amputation. It 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.

  • Physical activity level [ Time Frame: Baseline, end of treatment, 3 weeks post treatment ] [ Designated as safety issue: No ]
    An accelerometer will be attached to the prosthetic ankle of the subjects throughout the study. The accelerometer will gather information on subject's physical activities using total energy expenditure (kcal/d), and total step counts.


Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nintendo Wii
Subjects (n=10) in the experimental arm will be trained using the Wii for 40-minute sessions, 3 times a week for a period of 4 weeks. Subjects will stand on the Wii balance board and interact with the Wii games through weight shifting. The intervention protocol includes: 1) Yoga (static single and double leg exercises), 2) Balance games (lateral and poster/anterior weight shifting exercises in standing), 3) Aerobics (running on spot and step class), and 4) Strength training (dynamic single and double leg exercises). Each component will be practiced for 10 minutes in each session. For onsite training sessions, a trained research assistant will administer the intervention and will provide external cueing and correction of the pose if the participants use unsafe technique.
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.
No Intervention: Cognitive games
Subjects (n=10) in the control arm will play cognitive computer games using Lumosity Brain Training program for the same frequency and duration as the experimental arm. For onsite training sessions a separate research assistant will administer the intervention and will provide supervision. Lumosity is an online program which has games and exercises to improve cognitive function (www.lumosity.com).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • at least 1 year post a unilateral transtibial or transfemoral amputation
  • 60 years of age or older
  • have been using a prosthesis for at least 6 months prior to participation in the study
  • have poor balance confidence as indicated by a score of < 80% on the Activities-specific Balance Confidence scale at screening

Exclusion Criteria:

  • are not able to provide an informed consent form
  • have significant medical conditions that contraindicate participation in exercise program
  • have prosthetic socket fit issues, as indicated by scores ≤6 on the Prosthetic Socket Fit Comfort Scale
  • are currently participating in another formal exercise or training program.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715662

Contacts
Contact: Bita Imam, Bsc 604-714-4108 bita.imam@vch.ca

Locations
Canada, British Columbia
GF Strong Recruiting
Vancouver, British Columbia, Canada, V5Z 2G9
Contact: Bita Imam, MA    604-714-4108    bita.imam@vch.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 Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Bita Imam, MA    604-714-4108    bita.imam@vch.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 Recruiting
Vancouver, British Columbia, Canada, V5P 3L6
Contact: Bita Imam, MA    604-714-4108    bita.imam@vch.ca   
Contact: William C. Miller, PhD    604-714-4107    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, PhD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01715662     History of Changes
Other Study ID Numbers: H11-01246
Study First Received: October 15, 2012
Last Updated: January 29, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
rehabilitation
lower limb amputation
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 16, 2014