Effects of Vestibular Rehabilitation in the Treatment of Dizziness and Balance Disturbances After Concussion

NCT ID: NCT06700252

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-25
• Study Completion Date: 2023-02-28

Brief Summary

The goal of this clinical trial is to study the effects of including vestibular rehabilitation in the treatment of dizziness and balance disturbances in athletes after concussion. The main questions it aims to answer are:

• Does inclusion of vestibular rehabilitation treatment have an effect on symptom resolution in those with concussion?
• Does inclusion of vestibular rehabilitation treatment have an effect on the rate of recovery and return to play after concussion? Researchers will compare vestibular rehabilitation treatment inclusion in concussion treatment to a traditional concussion treatment approach to see if the rate of symptom resolution and return to play are affected by including vestibular rehabilitation for participants who have experienced a concussion within one week of presenting for the study.

Participants will:

• Be randomly assigned to either receive vestibular rehabilitation included in their concussion treatment or have traditional concussion treatment without vestibular rehabilitation.
• Complete treatment sessions two times per week for up to four weeks
• Complete the corresponding home program for the treatment group
• Complete baseline symptom testing and repeat the symptom testing at study completion for data comparison. Testing includes: Sport Concussion Assessment Tool (SCAT5) including 1) the athlete's background 2) symptom evaluation 3) cognitive screening 4) neurological screening and 5) delayed recall, a Dynamic Gait Index (DGI) including 1) gait on level surface 2) change in gait speed 3) gait with horizontal head turns 4) gait with vertical head turns 5) gait and pivot turn 6) step over obstacle 7) step around obstacle 8) stairs, and a vestibular evaluation including 1) patient history 2) visual assessment 3) vertebral artery clearance 4) cervical spine clearance 5) inner ear assessment 6) brief balance assessment.

Detailed Description

Nothing further to include that is not entered or uploaded elsewhere in the record

Conditions

Concussion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vestibular Rehabilitation

This arm of the study received the vestibular rehabilitation treatment in addition to following traditional protocol.

Group Type: EXPERIMENTAL

Vestibular Rehabilitation

Intervention Type: OTHER

This intervention used gaze stabilization, habituation, balance training and exertional training. Exercises utilized included visual tracking, gaze holding with head turns, saccades, visual accommodation exercises, visual convergence exercises, positional accommodation, rockerboard proprioception, single leg balance on the floor and on dynamic surfaces, tandem balance on the floor and on dynamic surfaces, double leg balance on dynamic surfaces, mirror feedback of functional activities, and physical exertion training with walking, biking or sport specific activities.

Traditional Treatment

This arm of the study received the traditional protocol in a stepwise progression only.

Group Type: ACTIVE_COMPARATOR

Traditional Protocol

Intervention Type: OTHER

This intervention symptom management and graduated return to physical activity involving a stepwise progression in which the participant proceeded to the next step if symptom-free at the current step for a 24-hour period. If any symptoms occurred at that step, the participant was returned to the previous step and tried to progress again after 24 hours of rest. The steps were as follows: 1) Patient to return to regular activities such as school 2) Light aerobic activity to increase the patient's heart rate achieved with 5 to 10 minutes on a stationary bike or walking but without weightlifting 3) Moderate activity which increased the heart rate with head or body movement that may have included sport specific exercise with minimal-moderate resistance 4) Heavy, non-contact activity in three planes of movement 5) Full contact practice 6) Competition

Interventions

Vestibular Rehabilitation

This intervention used gaze stabilization, habituation, balance training and exertional training. Exercises utilized included visual tracking, gaze holding with head turns, saccades, visual accommodation exercises, visual convergence exercises, positional accommodation, rockerboard proprioception, single leg balance on the floor and on dynamic surfaces, tandem balance on the floor and on dynamic surfaces, double leg balance on dynamic surfaces, mirror feedback of functional activities, and physical exertion training with walking, biking or sport specific activities.

Intervention Type: OTHER

Traditional Protocol

This intervention symptom management and graduated return to physical activity involving a stepwise progression in which the participant proceeded to the next step if symptom-free at the current step for a 24-hour period. If any symptoms occurred at that step, the participant was returned to the previous step and tried to progress again after 24 hours of rest. The steps were as follows: 1) Patient to return to regular activities such as school 2) Light aerobic activity to increase the patient's heart rate achieved with 5 to 10 minutes on a stationary bike or walking but without weightlifting 3) Moderate activity which increased the heart rate with head or body movement that may have included sport specific exercise with minimal-moderate resistance 4) Heavy, non-contact activity in three planes of movement 5) Full contact practice 6) Competition

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Athlete from a small regional university
• Experiences a concussion
• Identified by their certified athletic trainer to have dizziness or balance dysfunctions
• Referred for initial contact testing and treatment

Exclusion Criteria

• Acute spinal cord injury with neurological deficits
• Epidural and subdural hematoma with known manifestations
• Acute cervical spine injury

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

Sponsors

Minot State University

OTHER

Sponsor Role: collaborator

Beth Marschner

OTHER

Sponsor Role: lead

Responsible Party

Beth Marschner

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Beth Marschner, DPT

Role: PRINCIPAL_INVESTIGATOR

Minot State University

Locations

Minot State University

Minot, North Dakota, United States

Countries

United States

Other Identifiers

2133

Identifier Type: -

Identifier Source: org_study_id