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

Below Knee Amputation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01131819
• Other study ID #: H09-00523
• Status: Completed
• Phase: N/A
• Start date: May 2010
• Est. completion date: September 2012

Study information

• Verified date: May 2018
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Below Knee Amputation

Intervention

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.

Locations

Country	Name	City	State
Canada	Rehab Research Lab, GF Strong Rehab Centre	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short Physical Performance Battery	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
Primary	NeuroCom Clinical Research System	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	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.	Collected at each data collection session
Secondary	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.	Collected at each data collection session
Secondary	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.	Collected at each data collection session
Secondary	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.	Collected at the end of the project
Secondary	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.	Collected weekly