The Impact of Yoga-based Physical Therapy for Individuals With Traumatic Brain Injury
NCT03701594 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2019-11-29
Summary
This study aims to explore if a yoga-based physical therapy session would promote improved (increased) heart rate variability in subjects with traumatic brain injuries. The results of this pilot study may inform a larger-scale study of the effects of regular participation in a yoga-based program as an adjunct to traditional physical therapy. The secondary objective is to determine whether a yoga-based physical therapy session would impact anxiety, fatigue, or agitation and/or sleep quality. The study will enroll up to 30 inpatient subjects on a rolling basis as they are admitted with traumatic brain injury over a 12 month period at the Shirley Ryan AbilityLab.
Each person in the study will participate in three conditions in a random order across three days: 1 hour of yoga-based physical therapy session in a group setting,1 hour of one-on-one conventional physical therapy, and 1 hour of seated rest in a relaxing environment in a group setting.
The hypothesis is that individuals who participate in 1 hour of a yoga-based physical therapy session in a group setting will demonstrate a significant improvement in heart rate variability, anxiety, fatigue, and agitation after the session when compared to the same measures after 1 hour of a conventional physical therapy session and 1 hour of seated rest in a relaxing environment. Sleep will also be assessed with an activity monitor.
Conditions
Interventions
- OTHER
-
Yoga-based physical therapy group
All yoga-based sessions will be led by the same therapist to maximize between-session consistency. A trained researcher will also be present to provide additional cueing to subjects when required. The basic elements of the postures are similar to that of traditional physical therapy balance exercises. Cues will be provided throughout to pair appropriate breath cycles with appropriate postures consistent with a standard, able-bodied yoga program. The session will close with a 4-5 minute savasana performed in a supine or seated position pending patient physical abilities, which consists of progressive relaxation, guided meditation, and guided motor imagery.
- OTHER
-
Seated Rest
Subjects will engage in 1 hour of seated rest in a relaxing environment in a group of approximately 2-5 individuals. This session will occur in the same enclosed, quiet space as condition A to minimize outside noise or distraction and to reproduce environment of condition A. The lights will be dimmed, and the same light, instrumental, calming music will be played throughout to contribute to a relaxing ambiance. Subjects will be instructed to rest quietly.
- OTHER
-
Conventional Physical Therapy
Subjects will engage in 1 hour of a conventional PT session (or "treatment as usual") led by a different physical therapist than who is leading the yoga-based session to minimize bias. There will be no restrictions on what can and cannot occur during conventional PT sessions in order to accurately represent and preserve the wide range of treatments that may occur during a physical therapy session in the inpatient setting. Examples of what may occur include, but are not limited to: gait, standing balance, functional mobility, or therapeutic exercise.
Sponsors & Collaborators
-
Shirley Ryan AbilityLab
collaborator OTHER - lead OTHER
Principal Investigators
-
David Ripley, MD · Shirley Ryan AbilityLab
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-10-22
- Primary Completion
- 2019-04-01
- Completion
- 2019-04-01
Countries
- United States
Study Locations
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