Neural Markers of Balance in Adults With Brain Injury

NCT05895084 | Completed

• 1 other identifier: ECI Feasibility Study
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (8)

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

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

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

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

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

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

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

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

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

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

Study Arms (1)

Group Yoga

EXPERIMENTAL

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

Behavioral: Group Yoga

Interventions

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.

Also known as: Adaptive Yoga

Group Yoga

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colorado State University: lead

Study Sites (1)

Colorado State University - SCORE Research Lab

Fort Collins, Colorado, 80521, United States

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Jaclyn A Stephens, PhD, OTR/L

  Colorado State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: June 8, 2023
• Study Start: August 30, 2021
• Primary Completion: November 18, 2021
• Study Completion: November 18, 2021
• Last Updated: June 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Upon request - available for 5 years

Locations

US (1)