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Completed

NCT Number: NCT03008434

Traumatic Brain Injury and Yoga

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Colorado State University

Fort Collins, Colorado, 80521, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assigned Interventions

Other

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

Primary outcomes

  1. Berg Balance Scale

    Time frame: 8 weeks

    14 items to assess balance 14 items to assess balance 14 items to assess balance

Secondary outcomes

  1. Activities Balance Confidence Scale

    Time frame: 8 weeks

    Assess balance self-efficacy or confidence to maintain balance while performing different actions.

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 2, 2017
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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