Ignite Creation Date:
2024-05-06 @ 2:18 AM
Last Modification Date:
2024-10-26 @ 11:17 AM
Study NCT ID:
NCT02019173
Status:
COMPLETED
Last Update Posted:
2015-03-24
First Post:
2013-12-09
Brief Title:
Rehabilitation Boot Camp Intensive Balance and Mobility Therapy for People With Acquired Brain Injury
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
Rehabilitation Boot Camp an Innovative Four-Week Program to Deliver Intensive Balance and Mobility Therapy to People With Acquired Brain Injury ABI
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 hoursday 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 timeday staffing levelsday and adverse events will be used to support feasibility and safety of this model
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 hoursday 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 timeday staffing levelsday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None