NCT03008434

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

December 29, 2016

Last Update Submit

June 13, 2023

Conditions

Traumatic Brain Injury

Keywords

yogaTraumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • Berg Balance Scale

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

    8 weeks

Secondary Outcomes (1)

  • Activities Balance Confidence Scale

    8 weeks

Study Arms (1)

Yoga Group

EXPERIMENTAL

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

Other: Assigned Interventions

Interventions

Assigned InterventionsOTHER

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

Yoga Group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic TBI (\>6 months)
  • greater than or equal to 18 years of age
  • no consistent practice of yoga in the last year

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Colorado State University

Fort Collins, Colorado, 80521, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Arlene Schmid, PhD

    Colorado State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 29, 2016

First Posted

January 2, 2017

Study Start

October 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

June 15, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)