search
Back to results

Rehabilitation Boot Camp: Intensive Balance and Mobility Therapy for People With Acquired Brain Injury

Primary Purpose

Brain Injuries

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Boot Camp Balance Training
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries focused on measuring exercise therapy, brain injury, postural balance

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Moderate to Severe Acquired Brain Injury due to trauma, anoxia or infection, one to five years since onset
  • Re: Physical Function:

    • Able to sit independently unsupported at the edge of the bed
    • Able to assist rising from sit to stand
    • Able to stand unsupported (with or without supervision) for at least thirty seconds.
    • Standing tolerance of at least 3 minutes (may use upper limb support to stabilize).
    • Able to voluntarily move at least one leg (with or without synergic movements).
    • Functional use of at least one arm and able to lift to 90˚ shoulder elevation.
    • If the person is able to walk independently, he or she requires a walking aide, has difficulty walking outdoors or on uneven terrain, and/or demonstrates an abnormal gait pattern.
    • Medically stable and with the tolerance to be physically and mentally active over the treatment day with appropriate rests.
    • Can safely and independently eat, drink and use a toilet OR availability of an assistant to help with these functions.
  • 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:

  • ABI due to primary Cerebral Vascular Accident (Stroke).
  • Mild ABI/concussion.
  • not able to perform the above physical criteria, OR regularly walking in all conditions, outdoors without a walking aide and without any apparent gait deficit will not be eligible.
  • Unwilling to provide permission for researchers to obtain medical approval to participate in program.

Sites / Locations

  • University of Manitoba, School of Medical Rehabilitation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Boot camp balance training

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from baseline measure in time (seconds) to perform Five Times Sit to Stand Test
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
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
Change in distance walked (meters) from baseline measure in the Two Minute Walk Test (2 MWT)
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.

Full Information

First Posted
December 9, 2013
Last Updated
March 19, 2015
Sponsor
University of Manitoba
search

1. Study Identification

Unique Protocol Identification Number
NCT02019173
Brief Title
Rehabilitation Boot Camp: Intensive Balance and Mobility Therapy for People With Acquired Brain Injury
Official Title
Rehabilitation Boot Camp: an Innovative, Four-Week Program to Deliver Intensive Balance and Mobility Therapy to People With Acquired Brain Injury (ABI)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine 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. If they show improvements compared to 4 weeks of not receiving this treatment 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.
Detailed Description
See below for details about outcome measures and eligibility criteria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries
Keywords
exercise therapy, brain injury, postural balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Boot camp balance training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Boot Camp Balance Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline measure of Dual Task Cost of a visual cognitive task on stationery balance
Description
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.
Time Frame
This will be assessed 5 weeks prior, 1 week prior, 1 week post intervention
Secondary Outcome Measure Information:
Title
Change from baseline measure in time (seconds) to perform Five Times Sit to Stand Test
Time Frame
5 weeks, 1 week prior and 1 week post intervention
Title
Change in score from baseline measure in Chedoke McMaster Stroke Assessment Activity Scale
Description
A variety of functional mobility tasks including bed mobility, transfers, walking and stairs are performed and rated on a 7-point scale
Time Frame
5 weeks, 1 week prior and 1 week post intervention
Title
Change from baseline measure of the Sway Path Length during The Modified Clinical Test of Integration in Balance (mCTSIB)
Description
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
Time Frame
5 weeks, 1 week prior and 1 week post intervention
Title
Change in distance walked (meters) from baseline measure in the Two Minute Walk Test (2 MWT)
Time Frame
5 weeks, 1 week pre and 1 week post intervention.
Title
Change in score from baseline measure in the Participation Assessment with Recombined Tools - Objective 17 (PART-O 17)
Description
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.
Time Frame
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
Other Pre-specified Outcome Measures:
Title
Number of Adverse Events
Description
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).
Time Frame
This will be recorded on a daily basis on days that participant is receiving the intervention
Title
Level of staffing required
Description
For every participant attendance day the number of therapy staff members required will be recorded.
Time Frame
This will be recorded on a daily basis on the days that participants receive the intervention (4 weeks)
Title
Amount and of Function Repetitive Task Practice per Treatment Day
Description
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
Time Frame
This will be recorded on a daily basis on the days that participants receive the intervention (4 weeks)
Title
Change from baseline on Balance Performance during an Individualized Task from ba
Description
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.
Time Frame
5 weeks, 1 week, every treatment day during the intervention, and 1 week post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Moderate to Severe Acquired Brain Injury due to trauma, anoxia or infection, one to five years since onset Re: Physical Function: Able to sit independently unsupported at the edge of the bed Able to assist rising from sit to stand Able to stand unsupported (with or without supervision) for at least thirty seconds. Standing tolerance of at least 3 minutes (may use upper limb support to stabilize). Able to voluntarily move at least one leg (with or without synergic movements). Functional use of at least one arm and able to lift to 90˚ shoulder elevation. If the person is able to walk independently, he or she requires a walking aide, has difficulty walking outdoors or on uneven terrain, and/or demonstrates an abnormal gait pattern. Medically stable and with the tolerance to be physically and mentally active over the treatment day with appropriate rests. Can safely and independently eat, drink and use a toilet OR availability of an assistant to help with these functions. 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: ABI due to primary Cerebral Vascular Accident (Stroke). Mild ABI/concussion. not able to perform the above physical criteria, OR regularly walking in all conditions, outdoors without a walking aide and without any apparent gait deficit will not be eligible. Unwilling to provide permission for researchers to obtain medical approval to participate in program.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristabel Nett, BMR(PT)
Organizational Affiliation
University of Manitoba (MSc candidate)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Manitoba, School of Medical Rehabilitation
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Rehabilitation Boot Camp: Intensive Balance and Mobility Therapy for People With Acquired Brain Injury

We'll reach out to this number within 24 hrs