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NCT03701594 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Shirley Ryan AbilityLab.

Completed
Registry status
NA
Development phase
13
Enrollment target

NCT03701594: Completed NA study, sponsored by Shirley Ryan AbilityLab.

NCT03701594 is a NA study that has completed, run by Shirley Ryan AbilityLab. The registered enrollment target is 13 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03701594, a NA study, has completed, sponsored by Shirley Ryan AbilityLab.

COMPLETED
Registry status
NA
Development phase
13 participants
Enrollment target

Study 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.

Primary Outcome

Heart rate variability will be measured by MC-10 sensors placed on the chest.

Interventions

  • OTHER Conventional Physical Therapy
  • OTHER Seated Rest
  • OTHER Yoga-based physical therapy group

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2018-10-22
Est. Completion 2019-04-01
Phase NA
Shirley Ryan AbilityLab

138 total trials

What the finished NCT03701594 record still lists

NCT03701594 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 3 interventions - of which Conventional Physical Therapy is the first listed.

NCT03701594 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03701594 about?

NCT03701594 is a clinical study titled "The Impact of Yoga-based Physical Therapy for Individuals With Traumatic Brain Injury". 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 ...

What is the current status of trial NCT03701594?

This trial is currently completed. It is a NA study. The enrollment target is 13 participants. The study started on 2018-10-22. Estimated completion is 2019-04-01.

What interventions are being tested in trial NCT03701594?

The interventions under investigation include: Conventional Physical Therapy (OTHER), Seated Rest (OTHER), Yoga-based physical therapy group (OTHER).

Who is sponsoring clinical trial NCT03701594?

This trial is sponsored by Shirley Ryan AbilityLab, which has 138 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03701594's enrollment target sits among peer trials

13 1911th of 2000 higher than 88 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03701594, the US trial registry maintained by the National Library of Medicine. NCT03701594 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.