Clinical trial NCT01131819: Use of an Interactive Video Game as Part of a New Amputee Rehabilitation Program
Official title: Use of an Interactive Video Game as Part of a New Amputee Rehabilitation Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Below Knee Amputation
Keywords: Trans-tibial Amputation
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2010-05-27
Enrollment: 8
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Short Physical Performance Battery
measure: NeuroCom Clinical Research System
Secondary outcomes:
measure: 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.
measure: 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.
measure: 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.
measure: 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.
measure: 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.
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Rehab Research Lab, GF Strong Rehab Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: William C. Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References: