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

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.

Study Overview

• Status: Completed
• Conditions: Concussion
• Intervention / Treatment: Other: Vestibular Rehabilitation; Other: Traditional Protocol

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Minot, North Dakota, United States, 58707
      • Minot State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vestibular Rehabilitation; This arm of the study received the vestibular rehabilitation treatment in addition to following traditional protocol.	Other: 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.
Active Comparator: Traditional Treatment; This arm of the study received the traditional protocol in a stepwise progression only.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Beth Marschner
• Collaborators: Minot State University
• Investigators: Principal Investigator: Beth Marschner, DPT, Minot State University

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: November 19, 2024
• First Posted (Estimated): November 21, 2024

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Concussion; Dizziness; Vestibular Rehabilitation; Balance Disturbances
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Labyrinth Diseases; Vestibular Diseases; Vertigo; Dizziness
• Other Study ID Numbers: 2133 (European Union Funding for Research and Innovation - HORIZON 2020)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual participant data is not the main focus of the study. The overall findings of the study with the larger number of participants to look at the trend is what will be shared (presented or published). The IRB proposal for this study included confidentiality of each individual participant as that will be maintained, but the global findings are what will be shared after data analysis for comparison.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No