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

November 19, 2024 updated by: Beth Marschner

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dynamic Gait Index
Time Frame: Up to 4 weeks
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
Time Frame: Up to 4 weeks
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
Time Frame: Up to 4 weeks
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
Time Frame: Up to 4 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beth Marschner

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Minot State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Beth Marschner, DPT, Minot State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 25, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings