Clinical trial NCT05895084: Neural Markers of Balance in Adults With Brain Injury
Official title: Neural Markers of Static & Dynamic Balance Before & After Yoga in Adults With Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries
Lead sponsor: Colorado State University
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The feasibility study is designed to assess the feasibility of conducting a group yoga intervention and acquiring neuroimaging data in adults with chronic brain injury.

Detailed description: In the United States in 2014, nearly 2.9 million individuals sustained traumatic brain injuries that resulted in emergency department visits, hospitalizations, and death. Traumatic brain injury (TBI) is caused by trauma, or an external force that creates rapid acceleration and deceleration of the brain within the skull creating lasting neurophysiological dysfunction. Although there are many effective treatment strategies for the weeks and months post-injury (e.g. intensive, multi-disciplinary in-patient rehabilitation), millions of individuals are living with residual disability from brain injury following discharge to home. This residual disability can include significant social, cognitive, emotional, and physical impairment. To date, there are limited strategies for treating the residual deficits of chronic brain injury. One such physical deficit is balance impairment, which is associated with increased fall risk, reduced community integration, and decreased quality of life. The use of intensive, holistic rehabilitation may be effective for improving balance and other impairments in individuals with chronic brain injury. Yoga, a holistic treatment option, is thought to be more therapeutic than traditional exercise because of the integration of the mind, body, and spirit. Further, yoga can be modified to accommodate individual abilities and needs. And, unlike formal rehabilitation, yoga does not need to be approved by insurance or prescribed by a physician and adapted yoga is available in the community. Thus, yoga is readily available, so long as yoga instructors are trained to appropriately modify activities. Recently, the research team found that group yoga improved balance performance in seven adults with chronic brain injury. This study is designed to test the feasibility of conducting another group yoga intervention and acquiring neuroimaging data before and after the intervention.

Eligibility criteria: Inclusion Criteria:

* Adults, ages 18+
* Diagnosis of traumatic brain injury (TBI) or acquired brain injury (ABI) that occurred ≥ 6 months prior,
* Self-reported balance limitations.

Exclusion Criteria:

* Ability to engage in non-adapted (i.e. mainstream) yoga classes
* Standard contraindications for MRI (e.g. metal plates in head, claustrophobia, etc.)\*

  * Individuals could still participate in the group yoga intervention even if they could not complete MRI scans.

Primary outcomes:
measure: Change in Balance Performance from Baseline to Post-Intervention Timepoint
timeFrame: Baseline was ~ 2 weeks before the start of group yoga; Post-Intervention was after the last group yoga class, which was 12-13 weeks after baseline assessment.
measure: Change in Executive Functioning from Baseline to Post-Intervention Timepoint
timeFrame: Baseline was ~ 2 weeks before the start of group yoga; Post-Intervention was after the last group yoga class, which was 12-13 weeks after baseline assessment.
Secondary outcomes:
measure: Resting State Functional Magnetic Resonance Imaging (rs-fMRI) - Feasibility Benchmark of Safety at Baseline
timeFrame: Baseline was ~ 2 weeks before the start of group yoga.
measure: Resting State Functional Magnetic Resonance Imaging (rs-fMRI) - Feasibility Benchmark of Safety at Post-Intervention
timeFrame: Post-Intervention was after the last group yoga class, which was 12-13 weeks after baseline assessment.
measure: Resting State Functional Magnetic Resonance Imaging (rs-fMRI) - Feasibility Benchmark of Data Quality at Baseline
timeFrame: Baseline was ~ 2 weeks before the start of group yoga.
measure: Resting State Functional Magnetic Resonance Imaging (rs-fMRI) - Feasibility Benchmark of Data Quality at Post Intervention
timeFrame: Post-Intervention was after the last group yoga class, which was 12-13 weeks after baseline assessment.
measure: Functional Near-Infrared Spectroscopy (fNIRS) - Feasibility Benchmark of Safety at Baseline
timeFrame: Baseline was ~ 2 weeks before the start of group yoga.
measure: Functional Near-Infrared Spectroscopy (fNIRS) - Feasibility Benchmark of Safety at Post-Intervention.
timeFrame: Post-Intervention was after the last group yoga class, which was 12-13 weeks after baseline assessment.
measure: Functional Near-Infrared Spectroscopy (fNIRS) - Feasibility Benchmark of Data Quality at Baseline
timeFrame: Baseline was ~ 2 weeks before the start of group yoga.
measure: Functional Near-Infrared Spectroscopy (fNIRS) - Feasibility Benchmark of Data Quality at Post-Intervention
timeFrame: Post-Intervention was after the last group yoga class, which was 12-13 weeks after baseline assessment.
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University - SCORE Research Lab
state: Colorado
Study officials:
affiliation: Colorado State University
name: Jaclyn A Stephens, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References: