Traumatic Brain Injury and Yoga

Traumatic Brain Injury Clinical Trial

Official title:

Traumatic Brain Injury and Yoga

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03008434
• Other study ID #: 15-5905H
• Status: Completed
• Phase: Phase 1
• Start date: October 2015
• Est. completion date: April 2016

Study information

• Verified date: June 2023
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Other:
• Assigned Interventions
Yoga Group: designed for chronic TBI was provided two times a week for 8 weeks.

Locations

Country	Name	City	State
United States	Colorado State University	Fort Collins	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Colorado State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Berg Balance Scale	14 items to assess balance 14 items to assess balance 14 items to assess balance	8 weeks
Secondary	Activities Balance Confidence Scale	Assess balance self-efficacy or confidence to maintain balance while performing different actions.	8 weeks