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Completed

NCT Number: NCT05895084

Neural Markers of Balance in Adults With Brain Injury

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.

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Key information

Conditions

Brain Injuries Brain Diseases Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colorado State University - SCORE Research Lab

Fort Collins, Colorado, 80521, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group Yoga

Behavioral

Yoga is delivered as described in an earlier section in a group format. Classes are an hour in duration and occur once per week for 8 weeks, and they are led by an adaptive yoga specialist.

Other names: Adaptive Yoga

Primary outcomes

  1. Change in Balance Performance from Baseline to Post-Intervention Timepoint

    Time frame: 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.

    Six balance tasks, adapted from the Berg Balance Scale, were administered with simultaneous functional near infrared spectroscopy (see secondary outcomes). Each balance task was evaluated using Functional Independence Measure (FIM) scoring, ranging from 0 (dependent, unable to do) to 7 (independent, able to do without help). A composite score was generated by averaging FIM scores from each balance task. Change in balance was quantified as the difference in the post-intervention balance composite score and the baseline balance composite score.

  2. Change in Executive Functioning from Baseline to Post-Intervention Timepoint

    Time frame: 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.

    Executive function was assessed with a self-report measure, the Behavior Rating Inventory of Executive Function - Adult Version. The BRIEF-A includes nine clinical scales: inhibit, self-monitor, plan/organize, shift, initiate, task monitor, emotional control, working memory and organization of materials. Items are self-rated using a three-point frequency scale (1 = never; 2=sometimes; 3=often). These items contribute to two broad indexes, behavioral regulation and metacognition, which are combined for a summary score. Raw scores are transformed into a T-score. Higher T scores reflect more reported problems and T scores at or above 65 are considered clinically significant.

Secondary outcomes

  1. Resting State Functional Magnetic Resonance Imaging (rs-fMRI) - Feasibility Benchmark of Safety at Baseline

    Time frame: Baseline was ~ 2 weeks before the start of group yoga.

    The feasibility of safely acquiring rs-fMRI data was defined as the following: Detect 100% MRI contraindications during screening. Sustain zero instances of adverse events (e.g. pain or significant anxiety) or falls during data acquisition.

  2. Resting State Functional Magnetic Resonance Imaging (rs-fMRI) - Feasibility Benchmark of Safety at Post-Intervention

    Time frame: Post-Intervention was after the last group yoga class, which was 12-13 weeks after baseline assessment.

    The feasibility of safely acquiring rs-fMRI data was defined as the following: Detect 100% MRI contraindications during screening. Sustain zero instances of adverse events (e.g. pain or significant anxiety) or falls during data acquisition.

  3. Resting State Functional Magnetic Resonance Imaging (rs-fMRI) - Feasibility Benchmark of Data Quality at Baseline

    Time frame: Baseline was ~ 2 weeks before the start of group yoga.

    Rs-fMRI data quality was defined as meeting the following: Achieve time series quality indices < 3.5 * median absolute deviation (MAD) in ≥ 80% of data time points. Observe similar quality indices as achieved in a normative sample.

  4. Resting State Functional Magnetic Resonance Imaging (rs-fMRI) - Feasibility Benchmark of Data Quality at Post Intervention

    Time frame: Post-Intervention was after the last group yoga class, which was 12-13 weeks after baseline assessment.

    Rs-fMRI data quality was defined as meeting the following: Achieve time series quality indices < 3.5 * median absolute deviation (MAD) in ≥ 80% of data time points. Observe similar quality indices as achieved in a normative sample.

  5. Functional Near-Infrared Spectroscopy (fNIRS) - Feasibility Benchmark of Safety at Baseline

    Time frame: Baseline was ~ 2 weeks before the start of group yoga.

    The feasibility of safely acquiring fNIRS data was defined as the following: Have zero instances of adverse events (e.g. pain or anxiety) or falls during data acquisition.

  6. Functional Near-Infrared Spectroscopy (fNIRS) - Feasibility Benchmark of Safety at Post-Intervention.

    Time frame: Post-Intervention was after the last group yoga class, which was 12-13 weeks after baseline assessment.

    The feasibility of safely acquiring fNIRS data was defined as the following: Have zero instances of adverse events (e.g. pain or anxiety) or falls during data acquisition.

  7. Functional Near-Infrared Spectroscopy (fNIRS) - Feasibility Benchmark of Data Quality at Baseline

    Time frame: Baseline was ~ 2 weeks before the start of group yoga.

    FNIRS data quality was defined as meeting the following: Reach acceptable signal optimization and quality levels in ≥ 80% of participants assessed. Successfully detect and remove motion artifacts from data in ≥ 80% of participants assessed.

  8. Functional Near-Infrared Spectroscopy (fNIRS) - Feasibility Benchmark of Data Quality at Post-Intervention

    Time frame: Post-Intervention was after the last group yoga class, which was 12-13 weeks after baseline assessment.

    FNIRS data quality was defined as meeting the following: Reach acceptable signal optimization and quality levels in ≥ 80% of participants assessed. Successfully detect and remove motion artifacts from data in ≥ 80% of participants assessed.

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Registry information

Official study title

Neural Markers of Static & Dynamic Balance Before & After Yoga in Adults With Brain Injury

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 8, 2023
Registry last updated
Jun 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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