Neural Markers of Balance in Adults With Brain Injury

Brain Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05895084
• Other study ID #: ECI Feasibility Study
• Status: Completed
• Phase: N/A
• Start date: August 30, 2021
• Est. completion date: November 18, 2021

Study information

• Verified date: May 2023
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 18, 2021
• Est. primary completion date: November 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Wounds and Injuries

Intervention

Behavioral:
• Group Yoga
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.

Locations

Country	Name	City	State
United States	Colorado State University - SCORE Research Lab	Fort Collins	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Colorado State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Balance Performance from Baseline to Post-Intervention Timepoint	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.	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.
Primary	Change in Executive Functioning from Baseline to Post-Intervention Timepoint	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.	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	Resting State Functional Magnetic Resonance Imaging (rs-fMRI) - Feasibility Benchmark of Safety at Baseline	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.	Baseline was ~ 2 weeks before the start of group yoga.
Secondary	Resting State Functional Magnetic Resonance Imaging (rs-fMRI) - Feasibility Benchmark of Safety at Post-Intervention	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.	Post-Intervention was after the last group yoga class, which was 12-13 weeks after baseline assessment.
Secondary	Resting State Functional Magnetic Resonance Imaging (rs-fMRI) - Feasibility Benchmark of Data Quality at Baseline	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.	Baseline was ~ 2 weeks before the start of group yoga.
Secondary	Resting State Functional Magnetic Resonance Imaging (rs-fMRI) - Feasibility Benchmark of Data Quality at Post Intervention	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.	Post-Intervention was after the last group yoga class, which was 12-13 weeks after baseline assessment.
Secondary	Functional Near-Infrared Spectroscopy (fNIRS) - Feasibility Benchmark of Safety at Baseline	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.	Baseline was ~ 2 weeks before the start of group yoga.
Secondary	Functional Near-Infrared Spectroscopy (fNIRS) - Feasibility Benchmark of Safety at Post-Intervention.	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.	Post-Intervention was after the last group yoga class, which was 12-13 weeks after baseline assessment.
Secondary	Functional Near-Infrared Spectroscopy (fNIRS) - Feasibility Benchmark of Data Quality at Baseline	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.	Baseline was ~ 2 weeks before the start of group yoga.
Secondary	Functional Near-Infrared Spectroscopy (fNIRS) - Feasibility Benchmark of Data Quality at Post-Intervention	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.	Post-Intervention was after the last group yoga class, which was 12-13 weeks after baseline assessment.