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

NCT ID: NCT02019173

Last Updated: 2015-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-07-31

Brief 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.

Detailed Description

See below for details about outcome measures and eligibility criteria.

Conditions

Brain Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Boot camp balance training

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.

Group Type: EXPERIMENTAL

Boot Camp Balance Training

Intervention Type: 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.

Interventions

Boot Camp Balance Training

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cristabel Nett, BMR(PT)

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba (MSc candidate)

Locations

University of Manitoba, School of Medical Rehabilitation

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

H2013:403

Identifier Type: -

Identifier Source: org_study_id