Traumatic Brain Injury and Yoga

NCT ID: NCT03008434

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-04-30

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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Yoga Group

Yoga twice a week for 8 weeks focusing on balance and pain.

Group Type: EXPERIMENTAL

Assigned Interventions

Intervention Type: OTHER

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

Interventions

Assigned Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Colorado State University

OTHER

Sponsor Role: lead

Responsible Party

Arlene Schmid

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arlene Schmid, PhD

Role: PRINCIPAL_INVESTIGATOR

Colorado State University

Locations

Colorado State University

Fort Collins, Colorado, United States

Countries

United States

Other Identifiers

15-5905H

Identifier Type: -

Identifier Source: org_study_id