Neural Markers of Balance in Adults With Brain Injury

NCT ID: NCT05895084

Last Updated: 2023-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-30
• Study Completion Date: 2021-11-18

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.

Conditions

Brain Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group Yoga

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

Group Type: EXPERIMENTAL

Group Yoga

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Adaptive Yoga

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Colorado State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaclyn A Stephens, PhD, OTR/L

Role: PRINCIPAL_INVESTIGATOR

Colorado State University

Locations

Colorado State University - SCORE Research Lab

Fort Collins, Colorado, United States

Countries

United States

Other Identifiers

ECI Feasibility Study

Identifier Type: -

Identifier Source: org_study_id