The Impact of Yoga-based Physical Therapy for Individuals With Traumatic Brain Injury

Completed · Not applicable

Conditions studied: Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT03701594

Run by

Shirley Ryan AbilityLab

People needed

13

Starts

2018-10-22

Expected to finish

2019-04-01

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals diagnosed with traumatic brain injury admitted to the Shirley Ryan AbilityLab (SRALab)
• Age 18 or older
• Able and willing to give written consent or has an identified medical proxy willing to give written consent on behalf of the individual
• Able to follow commands consistently with a reasonable amount of verbal or visual cues in order to participate in a 60-minute physical therapy session in a group setting
• Able to attend to a task with reasonable amount of verbal or visual cues in order to participate in a 60-minute physical therapy session in a group setting
• Behaviorally appropriate for a group setting in terms of verbal or physical escalation/aggression

You may not qualify if…

• Serious cardiac conditions (arrhythmias) or neurological comorbidities (such as multiple sclerosis, Alzheimer's disease, Parkinson's disease, etc.)
• Pregnant or nursing
• Skin allergies or irritation; open wounds in the areas that the sensors would be applied to
• Utilizing a powered, implanted cardiac device for monitoring or supporting heart function (i.e. pacemaker, defibrillator, or LVAD)
• Non-English speaking patients, due to necessity for an interpreter to be present constantly interpreting, which could impact the low-stimulation setting of the intervention
• Aphasia or any difficulties in accurately self-reporting

Where it is running

• Shirley Ryan AbilityLab — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.