Traumatic Brain Injury and Yoga

June 13, 2023 updated by: Arlene Schmid, Colorado State University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Fort Collins, Colorado, United States, 80521
        • Colorado State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yoga Group
Yoga twice a week for 8 weeks focusing on balance and pain.
Other: Assigned Interventions
Yoga Group: designed for chronic TBI was provided two times a week for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg Balance Scale
Time Frame: 8 weeks
14 items to assess balance 14 items to assess balance 14 items to assess balance
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activities Balance Confidence Scale
Time Frame: 8 weeks
Assess balance self-efficacy or confidence to maintain balance while performing different actions.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colorado State University

Investigators

  • Principal Investigator: Arlene Schmid, PhD, Colorado State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

December 29, 2016

First Submitted That Met QC Criteria

December 29, 2016

First Posted (Estimated)

January 2, 2017

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-5905H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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