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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01131819
Enrollment
8
Registered
2010-05-27
Start date
2010-05-31
Completion date
2012-09-30
Last updated
2018-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Below Knee Amputation

Keywords

Trans-tibial Amputation

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.

Interventions

DEVICENintendo 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.

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Short Physical Performance BatteryThe 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 SystemThe 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

MeasureTime frameDescription
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
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
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
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
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026