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

Traumatic Brain Injury Clinical Trial

Official title: The Impact of Yoga-based Physical Therapy on Heart Rate Variability for Individuals With Traumatic Brain Injury: a Pilot Study

Status Completed

Clinical Trial 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.

Clinical Trial Description

Admissions to the traumatic brain injury service of Shirley Ryan AbilityLab will be reviewed on a weekly basis, and eligible patients will be approached to attain assent/consent. Patients will be randomized as to which condition they participate in first. Subjects will be instructed not to eat or drink caffeine within 1 hour of participating in a condition. A trained researcher will apply three sensors to the chest. The sensors to monitor heart rate variability (HRV) via electrocardiogram (EKG) are from the BioStampRC Discovery Kit MC10, Inc., and are research-grade, non-invasive, wireless, wearable sensors. For each sensor location, the skin will be prepped and cleaned using alcohol wipes. Sensors are placed on the skin using adhesive stickers that minimize irritation. Medical dressing (Tegaderm, 3M) may also be used to ensure adhesion and proper contact with the skin. Sensors will be cleaned with soap and water before and after use. Vital signs will be measured. The self-reported outcome measures will be administered by a blinded clinician.

The subject will participate in the assigned condition for that day as determined by randomization, and HRV will be monitored throughout the condition. Immediately following the 1-hour condition, the sensors will be removed by a trained researcher and the self-reported outcomes will again be administered under the supervision of a blinded clinician. Subjects will complete forms as able, but if they require physical assistance to fill out or verbal assistance in reading the questions, such assistance will be provided. Sleep quality will be captured by an activity monitor. Research staff will don and doff the activity monitors.

All sessions will be supervised by a physical therapist. Research staff will be responsible for all sensor recording practices, such as instrumenting the sensors and marking therapy activities on a computer tablet using the BioStampRC software. Research staff will also keep a written log of activities as they are undertaken during the assessments, including notable events, amount and type of assistance, or use of external devices. Logs will be consulted during analysis to compare with the timestamped sensor data.

Audio/video recording may be utilized in order to allow a registered yoga therapist to validate the yoga-based program led by the researcher-clinician physical therapist. The recordings would only be viewed by the physical therapist and registered yoga therapist, and destroyed after publication of the research. The videos would be stored in a password-protected device; the yoga therapist and physical therapist would be the only individuals with access. ;

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

• NCT number: NCT03701594
• Study type: Interventional
• Source: Northwestern University
• Status: Completed
• Phase: N/A
• Start date: October 22, 2018
• Completion date: April 1, 2019