The Impact of Yoga-based Physical Therapy for Individuals With Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Yoga-based physical therapy group; Seated Rest; Conventional Physical Therapy
Intervention type(s): Other; Other; Other
Intervention description(s): 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.; 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.; 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study will be a randomized, controlled, single-blinded, crossover design with three conditions: condition A will consist of 1 hour of yoga-based physical therapy session in a group setting; condition B will consist of 1 hour of one-on-one conventional physical therapy; condition C will consist of 1 hour of seated rest in a relaxing environment in a group setting.
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research