Brain InjuriesNCT02019173
Rehabilitation Boot Camp: Intensive Balance and Mobility Therapy for People With Acquired Brain Injury
A study testing Boot Camp Balance Training in people with Brain Injuries, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Boot Camp Balance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Manitoba, School of Medical Rehabilitation
Winnipeg, Manitoba, R3A 1M4
About this study
Official title: Rehabilitation Boot Camp: an Innovative, Four-Week Program to Deliver Intensive Balance and Mobility Therapy to People With Acquired Brain Injury (ABI)
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.
Read more
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.
Read the detailed description
See below for details about outcome measures and eligibility criteria.
- Conditions
- Brain Injuries
- Being tested
- Boot Camp Balance Training
- Keywords
- exercise therapy, brain injury, postural balance
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boot Camp Balance TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Boot Camp Balance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startJun 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristabel Nett, BMR(PT), Principal investigator, University of Manitoba (MSc candidate)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019173
- Sponsor's protocol ID
- H2013:403
- Status last verified
- Dec 2013
- First submitted
- 9 Dec 2013
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Boot Camp: an Innovative, Four-Week Program to Deliver Intensive Balance and Mobility Therapy to People With Acquired Brain Injury (ABI)
- ClinicalTrials.gov ID
- NCT02019173
- Acronym / sponsor ID
- H2013:403
- Conditions
- Brain Injuries
- Keywords
- exercise therapy, brain injury, postural balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 24 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Boot camp balance training | Experimental | Behavioral: Boot Camp Balance TrainingIntense 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boot Camp Balance TrainingIntense 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. | Behavioural | Boot camp balance training |
Primary outcome
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
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.
5 secondary outcomes
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
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
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
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristabel Nett, BMR(PT) principal investigator
University of Manitoba (MSc candidate)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boot Camp Balance Training in people with Brain Injuries, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2015.