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Neural Markers of Balance in Adults With Brain Injury

Primary Purpose

Brain Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Yoga
Sponsored by
Colorado State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Colorado State University - SCORE Research Lab

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group Yoga

Arm Description

Yoga includes breath work (pranayama), gentle stretching and holding of postures (asanas), and meditation (dhyana). Modifications/adaptations are incorporated so all participants can successfully complete the yoga intervention. Yoga is delivered in a standardized progression, including: focused, slow breath with movement and breathwork throughout every session; mantras, progressively challenging yoga postures (sitting, standing, and floor); and meditation

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 31, 2023
Last Updated
May 30, 2023
Sponsor
Colorado State University
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1. Study Identification

Unique Protocol Identification Number
NCT05895084
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 30, 2021 (Actual)
Primary Completion Date
November 18, 2021 (Actual)
Study Completion Date
November 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colorado State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Yoga
Arm Type
Experimental
Arm Description
Yoga includes breath work (pranayama), gentle stretching and holding of postures (asanas), and meditation (dhyana). Modifications/adaptations are incorporated so all participants can successfully complete the yoga intervention. Yoga is delivered in a standardized progression, including: focused, slow breath with movement and breathwork throughout every session; mantras, progressively challenging yoga postures (sitting, standing, and floor); and meditation
Intervention Type
Behavioral
Intervention Name(s)
Group Yoga
Other Intervention Name(s)
Adaptive Yoga
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Balance Performance from Baseline to Post-Intervention Timepoint
Description
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.
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.
Title
Change in Executive Functioning from Baseline to Post-Intervention Timepoint
Description
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.
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.
Secondary Outcome Measure Information:
Title
Resting State Functional Magnetic Resonance Imaging (rs-fMRI) - Feasibility Benchmark of Safety at Baseline
Description
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.
Time Frame
Baseline was ~ 2 weeks before the start of group yoga.
Title
Resting State Functional Magnetic Resonance Imaging (rs-fMRI) - Feasibility Benchmark of Safety at Post-Intervention
Description
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.
Time Frame
Post-Intervention was after the last group yoga class, which was 12-13 weeks after baseline assessment.
Title
Resting State Functional Magnetic Resonance Imaging (rs-fMRI) - Feasibility Benchmark of Data Quality at Baseline
Description
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.
Time Frame
Baseline was ~ 2 weeks before the start of group yoga.
Title
Resting State Functional Magnetic Resonance Imaging (rs-fMRI) - Feasibility Benchmark of Data Quality at Post Intervention
Description
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.
Time Frame
Post-Intervention was after the last group yoga class, which was 12-13 weeks after baseline assessment.
Title
Functional Near-Infrared Spectroscopy (fNIRS) - Feasibility Benchmark of Safety at Baseline
Description
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.
Time Frame
Baseline was ~ 2 weeks before the start of group yoga.
Title
Functional Near-Infrared Spectroscopy (fNIRS) - Feasibility Benchmark of Safety at Post-Intervention.
Description
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.
Time Frame
Post-Intervention was after the last group yoga class, which was 12-13 weeks after baseline assessment.
Title
Functional Near-Infrared Spectroscopy (fNIRS) - Feasibility Benchmark of Data Quality at Baseline
Description
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.
Time Frame
Baseline was ~ 2 weeks before the start of group yoga.
Title
Functional Near-Infrared Spectroscopy (fNIRS) - Feasibility Benchmark of Data Quality at Post-Intervention
Description
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.
Time Frame
Post-Intervention was after the last group yoga class, which was 12-13 weeks after baseline assessment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaclyn A Stephens, PhD, OTR/L
Organizational Affiliation
Colorado State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Colorado State University - SCORE Research Lab
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80521
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified participant data can be acquired upon request to the study PI, Dr. Jaclyn Stephens.
IPD Sharing Time Frame
Upon request - available for 5 years

Learn more about this trial

Neural Markers of Balance in Adults With Brain Injury

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