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The purpose of this study is to determine
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.
See below for details about outcome measures and eligibility criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Boot camp balance training | Experimental | Intense physical rehabilitation directed at improving balance and mobility will be provided to individuals in a group setting (6 participants in a group) for 4 weeks, 3 days a week for 6 hours per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boot Camp Balance Training | Behavioral | Intense physical rehabilitation directed at improving balance and mobility will be provided to individuals in a group setting (6 participants in a group) for 4 weeks, 3 days a week for 6 hours per day. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline measure of Dual Task Cost of a visual cognitive task on stationery balance | The sway path length (SPL) will be recorded while standing unsupported. The performance on a visual spatial task will be recorded using a computer program that is based on the Useful Field of View test while the subject is in supported sitting. Then the balance task and cognitive task will be performed simultaneously to generate a Dual Task Cost in performance. | This will be assessed 5 weeks prior, 1 week prior, 1 week post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline measure in time (seconds) to perform Five Times Sit to Stand Test | 5 weeks, 1 week prior and 1 week post intervention | |
| Change in score from baseline measure in Chedoke McMaster Stroke Assessment Activity Scale | A variety of functional mobility tasks including bed mobility, transfers, walking and stairs are performed and rated on a 7-point scale |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | Any change in health status will b recorded and categorized into either not related to intervention or related to the intervention. Those that are related to the intervention will be further categorized into "anticipated", "unanticipated minor" (i.e not requiring medical attention) and "unanticipated major"(requiring medical attention). | This will be recorded on a daily basis on days that participant is receiving the intervention |
Inclusion Criteria:
Moderate to Severe Acquired Brain Injury due to trauma, anoxia or infection, one to five years since onset
Re: Physical Function:
Sufficient Cognitive ability to provide informed consent.
English communication at a level to understand instruction and provide informed consent.
Impulse control and social skills to allow group participation with only occasional redirection from therapy staff
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristabel Nett, BMR(PT) | University of Manitoba (MSc candidate) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Manitoba, School of Medical Rehabilitation | Winnipeg | Manitoba | R3A 1M4 | Canada |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 18, 2015 | |
| Reset | Nov 19, 2015 | |
| Release | Dec 1, 2015 | |
| Reset | Jan 5, 2016 | |
| Release | Nov 29, 2017 | |
| Reset | Oct 4, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 18, 2015 | Nov 19, 2015 | |||
| Dec 1, 2015 |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| 5 weeks, 1 week prior and 1 week post intervention |
| Change from baseline measure of the Sway Path Length during The Modified Clinical Test of Integration in Balance (mCTSIB) | Ability to maintain still standing is assessed in 4 sensory conditions; on a solid surface eyes open, on a sponge surface eyes open, on a solid surface eyes closed and on a sponge surface eyes closed | 5 weeks, 1 week prior and 1 week post intervention |
| Change in distance walked (meters) from baseline measure in the Two Minute Walk Test (2 MWT) | 5 weeks, 1 week pre and 1 week post intervention. |
| Change in score from baseline measure in the Participation Assessment with Recombined Tools - Objective 17 (PART-O 17) | This is an interview-style questionnaire to quantify subject participation in the following domains; productivity, social relations and "out and about". It has been specifically developed for the brain injured population. | This will be performed at the following time points: 5 weeks prior to the intervention, 1 week prior to the intervention, one week after the intervention and 12 weeks after the intervention |
| Level of staffing required | For every participant attendance day the number of therapy staff members required will be recorded. | This will be recorded on a daily basis on the days that participants receive the intervention (4 weeks) |
| Amount and of Function Repetitive Task Practice per Treatment Day | The duration of all planned therapy activities will be recorded on each participant treatment day, to allow an average for each activity to be generated | This will be recorded on a daily basis on the days that participants receive the intervention (4 weeks) |
| Change from baseline on Balance Performance during an Individualized Task from ba | Center of foot pressure (COP) measures will be taken during an individualized rhythmic balance task, selected on the basis of the participants needs and level of ability. This will allow within-subject analysis to determine trajectory of balance skill change. | 5 weeks, 1 week, every treatment day during the intervention, and 1 week post intervention |
| Jan 5, 2016 |
| Nov 29, 2017 | Oct 4, 2018 |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |