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

NCT06700252 | Completed

• 1 other identifier: 2133
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion

Keywords

Vestibular Rehabilitation; Concussion; Dizziness; Balance Disturbances

Outcome Measures

Primary Outcomes (4)

• Dynamic Gait Index

  The Dynamic Gait Index (DGI) includes 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. Each item is scored on a four-point ordinal scale, ranging from 0-3. "0" indicates the lowest level of function, severe impairment and "3" indicates the highest level of function, normal. There are a total of 24 possible points. The lower the score out of 24, the more balance difficulties.

  Up to 4 weeks

• Sport Concussion Assessment Tool 5

  The Sport Concussion Assessment Tool 5 includes: athlete's background, symptom evaluation, cognitive screening, neurological screening, and delayed recall. The symptom scale is from 0 (none) to 6 (severe). There are 22 symptoms with a max score of 132. The higher the score, the more severe. The cognitive screening includes 5 orientation questions, immediate memory using recall of 5 word lists, concentration tasks of backward digit recall starting with three digits and progressing to more if able, recalling the months of the year in reverse and delayed recall at the end of the assessment for the immediate memory word list again. The neurological screening assesses reflexes, pupil response and motor function. Balance is examined using the modified balance error scoring system where more errors indicates more balance issues.

  Up to 4 weeks

• Oculomotor Assessment

  Oculomotor Assessment is used to evaluate eye movement and function to determine if movement and function are normal or abnormal. This includes: smooth pursuits, horizontal saccades, vertical saccades, convergence, vestibulo-ocular reflex (VOR), and visual motion sensitivity Test (VMS).

  Up to 4 weeks

• Semicircular Canal Assessment

  Semicircular Canal Assessment is used to evaluate how well the inner ear's semicircular canals detect head movement. Tests included in this were the Hallpike-Dix for assessing the posterior canal and the Roll Test for assessing the horizontal canal.

  Up to 4 weeks

Study Arms (2)

Vestibular Rehabilitation

EXPERIMENTAL

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

Other: Vestibular Rehabilitation

Traditional Treatment

ACTIVE COMPARATOR

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

Other: Traditional Protocol

Interventions

Vestibular Rehabilitation 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.

Vestibular Rehabilitation

Traditional Protocol 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

Traditional Treatment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Beth Marschner: lead
• Minot State University: collaborator

Study Sites (1)

Minot State University

Minot, North Dakota, 58707, United States

Location

MeSH Terms

Conditions

Brain Concussion; Dizziness

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Beth Marschner, DPT

  Minot State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: November 21, 2024
• Study Start: August 25, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)