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

NCT01131819 | Completed

• 1 other identifier: H09-00523
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Below Knee Amputation

Keywords

Trans-tibial Amputation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (1)

1

OTHER

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

Interventions

Nintendo Wii fit ™ balance board DEVICE

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.

1

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects who have an open wound that limits their wearing of the prosthesis

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Rehab Research Lab, GF Strong Rehab Centre

Vancouver, British Columbia, V5Z2G9, Canada

Location

Study Officials

• William C. Miller, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 21, 2010
• First Posted: May 27, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2012
• Last Updated: May 30, 2018

Record last verified: 2018-05

Locations

CA (1)