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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03008434
Other study ID # 15-5905H
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


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
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