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

NCT02019173 | Completed

• 1 other identifier: H2013:403
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine

1. 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. 2.If they show improvements compared to 4 weeks of not receiving this treatment
3. 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.

Conditions

Brain Injuries

Keywords

exercise therapy; brain injury; postural balance

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

  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)

  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 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 Outcomes (4)

• Number of Adverse Events

  This will be recorded on a daily basis on days that participant is receiving the intervention

• Level of staffing required

  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

  This will be recorded on a daily basis on the days that participants receive the intervention (4 weeks)

Study Arms (1)

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.

Behavioral: Boot Camp Balance Training

Interventions

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.

Boot camp balance training

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

University of Manitoba, School of Medical Rehabilitation

Winnipeg, Manitoba, R3A 1M4, Canada

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Cristabel Nett, BMR(PT)

  University of Manitoba (MSc candidate)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 24, 2013
• Study Start: June 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 24, 2015

Record last verified: 2013-12

Locations

CA (1)