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Clinical Trial Summary

The purpose of this study is to determine

1. if it is practical to treat moderately to severely brain injured patients who have problems with their balance and mobility in a group "boot camp" (3 days a week, 6 hours/day for 4 weeks) exercise class.

2. If they show improvements compared to 4 weeks of not receiving this treatment

3. If electronic daily monitoring of their center of foot pressure during a standardized balance task will allow us to see small changes in ability.

A baseline assessment of all outcome measures will be performed. This will be repeated 4 weeks later. The intervention will be delivered (4 weeks) and a follow up assessment of all outcome measures will be performed one week later. A follow up of the Primary outcome measure, the PART-O participation questionnaire will be done 12 weeks later.

Participants will attend group therapy consisting of a variety of exercises designed specifically to target balance and mobility deficits and based on the concept that through Repetitive Functional Task Practice (RFTP), recovery of function can occur as the result of neural adaptation. Exercises will be both individualized (delivered in a circuit) and group activities. Supervision and guidance will be provided by a registered Physical Therapist and a Rehabilitation Assistant. During the intervention, the amount and type of RFTP, any adverse events, and any need for extra staff will be recorded on a daily basis. As well, a standardized individualized task will be performed with center of foot pressure recording on a daily basis.

Analysis: changes in outcome measures immediately after the non-intervention compared to the after the intervention period will be statistically determined to estimate efficacy of this treatment model. Descriptive measures of RFTP time/day, staffing levels/day and adverse events will be used to support feasibility and safety of this model.


Clinical Trial Description

See below for details about outcome measures and eligibility criteria. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02019173
Study type Interventional
Source University of Manitoba
Contact
Status Completed
Phase N/A
Start date June 2014
Completion date July 2014

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