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Use of an Interactive Video Game as Part of a New Amputee Rehabilitation Program

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01131819
First received: May 21, 2010
Last updated: September 18, 2014
Last verified: September 2014
  Purpose

Purpose: The investigators wish to determine if a rehabilitation program for subjects with new, trans-tibial amputations that has the balance portion of the program augmented by the use of the Nintendo Wii fit ™ balance board improves their performance.

Hypothesis: The investigators hypothesize that subjects will benefit from the use of the device and that this will manifest as an improvement on outcome measures.


Condition Intervention
Below Knee Amputation
Device: Nintendo Wii fit ™ balance board

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of an Interactive Video Game as Part of a New Amputee Rehabilitation Program

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Short Physical Performance Battery [ Designated as safety issue: No ]
    The Short Physical Performance Battery (SPPB) measures subject's ability to perform three tasks: standing balance, gait speed and lower extremity strength (chair stands). Collected at each data collection session

  • NeuroCom Clinical Research System [ Designated as safety issue: No ]
    The NeuroCom Clinical Research System is a commercially available objective measure that is able to detect and document perturbations in balance in three (X, Y, Z components) planes in order to determine postural sway. The system consists of a dual platform that moves or does not move in conjunction with a visual surround. The Sensory Organization Test (SOT) will be used to test 3 sensory components of balance (visual, somatosensory and vestibular inputs) under 6 standard conditions. Collected at each data collection session.


Secondary Outcome Measures:
  • Walking ability will be measured using the L-Test. This walk test incorporates a sit-to-stand component, turns to both the left and the right over a distance of 20 meters. [ Designated as safety issue: No ]
    Collected at each data collection session

  • Walking endurance will be assessed using the 2 Minute Walk Test (2MWT). Starting from a standing position this test requires individuals to walk at a fast safe pace for a period of two minutes. [ Designated as safety issue: No ]
    Collected at each data collection session

  • Balance confidence will be measured using the 16 item Activities-specific Balance Confidence (ABC Scale). The items assess the perceived confidence (self-efficacy) the individual has in performing an increasing complex series of tasks. [ Designated as safety issue: No ]
    Collected at each data collection session

  • The Short Feedback Questionnaire-modified (SFQ-M) will be used to determine subjects' level of satisfaction with their rehabilitation program as well as with the interactive video game experience. [ Designated as safety issue: No ]
    Collected at the end of the project

  • A 9-item Falls Diary will be kept by each subject documenting number of falls, circumstances (eg/ cause, location, assistive device used or not) and consequences (eg/ medical visit, injury) over the past week. [ Designated as safety issue: No ]
    Collected weekly


Enrollment: 8
Study Start Date: May 2010
Study Completion Date: September 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
The novel intervention we propose to use, the Wii Fit, will be introduced for a period of at least 20 minutes but not greater than 30 minutes per day to all the subjects in the study.
Device: Nintendo Wii fit ™ balance board
Nintendo Wii fit ™ balance board will be introduced for a period of at least 20 minutes but not greater than 30 minutes per day to all the subjects for a minimum of 6 times in two weeks and a maximum of 18 times in 6 weeks.

Detailed Description:

All subjects will be trained by the same specialist physiotherapist. Subjects will use the Wii Fit balance platform for a period of twenty minutes or greater per day (at the discretion of the specialist physiotherapist) during their standard rehabilitation program. These balance training exercises will be in addition to those already used in the standard rehabilitation program, but will not add to the total therapy session time. Activities on the device will be chosen by the therapist based on the subjects' current abilities and their phase of training. More complicated tasks will be given as the subject progresses. The therapist will intervene and provide instruction / correction if the subject is using unsafe technique or poor technique (postures, positioning strategies that would not be condoned in the regular training program).

The device is a stable, level platform 5.5 cm from the floor. Subjects stand on the device and may use gait aids if indicated.

Standard practice involves intensive training of the subject by the same specialist physiotherapist but without the use of the Wii Fit platform.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consented subjects with new, unilateral, transtibial amputations who are greater than 19 years of age

Exclusion Criteria:

  • Subjects who have an open wound that limits their wearing of the prosthesis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01131819

Locations
Canada, British Columbia
Rehab Research Lab, GF Strong Rehab Centre
Vancouver, British Columbia, Canada, V5Z2G9
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: NCT01131819     History of Changes
Other Study ID Numbers: H09-00523
Study First Received: May 21, 2010
Last Updated: September 18, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Trans-tibial Amputation

ClinicalTrials.gov processed this record on November 19, 2014