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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by University of Manitoba
Sponsor:
Information provided by (Responsible Party):
University of Manitoba
ClinicalTrials.gov Identifier:
NCT02019173
First received: December 9, 2013
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Brain Injuries
Behavioral: Boot Camp Balance Training

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rehabilitation Boot Camp: an Innovative, Four-Week Program to Deliver Intensive Balance and Mobility Therapy to People With Acquired Brain Injury (ABI)

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Change from baseline measure of Dual Task Cost of a visual cognitive task on stationery balance [ Time Frame: This will be assessed 5 weeks prior, 1 week prior, 1 week post intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: 5 weeks, 1 week prior and 1 week post intervention ] [ Designated as safety issue: No ]
  • Change in score from baseline measure in Chedoke McMaster Stroke Assessment Activity Scale [ Time Frame: 5 weeks, 1 week prior and 1 week post intervention ] [ Designated as safety issue: No ]
    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) [ Time Frame: 5 weeks, 1 week prior and 1 week post intervention ] [ Designated as safety issue: No ]
    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) [ Time Frame: 5 weeks, 1 week pre and 1 week post intervention. ] [ Designated as safety issue: No ]
  • Change in score from baseline measure in the Participation Assessment with Recombined Tools - Objective 17 (PART-O 17) [ 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 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Number of Adverse Events [ Time Frame: This will be recorded on a daily basis on days that participant is receiving the intervention ] [ Designated as safety issue: Yes ]
    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).

  • Level of staffing required [ Time Frame: This will be recorded on a daily basis on the days that participants receive the intervention (4 weeks) ] [ Designated as safety issue: No ]
    For every participant attendance day the number of therapy staff members required will be recorded.

  • Amount and of Function Repetitive Task Practice per Treatment Day [ Time Frame: This will be recorded on a daily basis on the days that participants receive the intervention (4 weeks) ] [ Designated as safety issue: No ]
    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

  • Change from baseline on Balance Performance during an Individualized Task from ba [ Time Frame: 5 weeks, 1 week, every treatment day during the intervention, and 1 week post intervention ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 12
Study Start Date: April 2014
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: 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.

Detailed Description:

See below for details about outcome measures and eligibility criteria.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02019173

Locations
Canada, Manitoba
University of Manitoba, School of Medical Rehabilitation Not yet recruiting
Winnipeg, Manitoba, Canada, R3A 1M4
Contact: Cristabel Nett, BMR(PT)    204-787-1164    cristabel.nett@med.umanitoba.ca   
Principal Investigator: Cristabel Nett, BMR(PT)         
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Cristabel Nett, BMR(PT) University of Manitoba (MSc candidate)
  More Information

No publications provided

Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT02019173     History of Changes
Other Study ID Numbers: H2013:403
Study First Received: December 9, 2013
Last Updated: December 17, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
exercise therapy
brain injury
postural balance

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 01, 2014