Back to resultsTraumatic Brain Injury and Yoga
Primary Purpose
Traumatic Brain Injury
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Assigned Interventions
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring yoga, Traumatic Brain Injury
Eligibility Criteria
Inclusion Criteria:
- chronic TBI (>6 months)
- greater than or equal to 18 years of age
- no consistent practice of yoga in the last year
Exclusion Criteria:
- inability to provide informed consent
- less than 18 years of age
- self-report of exercise restriction
- consistent yoga practice within the last year
- inability to attend sessions based on transportation restrictions
Sites / Locations
- Colorado State University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Yoga Group
Arm Description
Yoga twice a week for 8 weeks focusing on balance and pain.
Outcomes
Primary Outcome Measures
Berg Balance Scale
14 items to assess balance 14 items to assess balance 14 items to assess balance
Secondary Outcome Measures
Activities Balance Confidence Scale
Assess balance self-efficacy or confidence to maintain balance while performing different actions.
Full Information
NCT ID
NCT03008434
First Posted
December 29, 2016
Last Updated
June 13, 2023
Sponsor
Colorado State University
1. Study Identification
Unique Protocol Identification Number
NCT03008434
Brief Title
Traumatic Brain Injury and Yoga
Official Title
Traumatic Brain Injury and Yoga
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Colorado State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This long-term goal of this project was to advance best practices in occupational therapy in conjunction with yoga. To address the long-term goal, this research team developed a pilot yoga intervention. The intervention was designed to focus on balance, balance confidence, body responsiveness, pain, physical ability and quality of life. Assessments were then chosen to address these areas pre and post yoga intervention. A manual and protocol were developed for the intervention and then the intervention was implemented with a group of individuals with chronic traumatic brain injury.
Detailed Description
This was an 8-week yoga intervention, focused on demonstrating the preliminary feasibility and efficacy of yoga for individuals with chronic traumatic brain injury. The study was a mixed-methods longitudinal study. Assessments were conducted 8 weeks prior to the yoga intervention and then just following the 8 week yoga intervention. The objectives of this feasibility and efficacy study was to 1) further develop, standardize, and manualize the yoga for the traumatic brain injury intervention and 2) assess change in balance, balance confidence, body responsiveness, pain, physical ability, and quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
yoga, Traumatic Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yoga Group
Arm Type
Experimental
Arm Description
Yoga twice a week for 8 weeks focusing on balance and pain.
Intervention Type
Other
Intervention Name(s)
Assigned Interventions
Intervention Description
Yoga Group: designed for chronic TBI was provided two times a week for 8 weeks.
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
14 items to assess balance 14 items to assess balance 14 items to assess balance
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Activities Balance Confidence Scale
Description
Assess balance self-efficacy or confidence to maintain balance while performing different actions.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
chronic TBI (>6 months)
greater than or equal to 18 years of age
no consistent practice of yoga in the last year
Exclusion Criteria:
inability to provide informed consent
less than 18 years of age
self-report of exercise restriction
consistent yoga practice within the last year
inability to attend sessions based on transportation restrictions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arlene Schmid, PhD
Organizational Affiliation
Colorado State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Colorado State University
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80521
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Traumatic Brain Injury and Yoga
We'll reach out to this number within 24 hrs