ConcussionNCT06700252
Effects of Vestibular Rehabilitation in the Treatment of Dizziness and Balance Disturbances After Concussion
A study testing Vestibular Rehabilitation and Traditional Protocol in people with Concussion, run by Beth Marschner at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Concussion
- What is being tested?
- Vestibular Rehabilitation and Traditional Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2022to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Acute spinal cord injury with neurological deficits
- Epidural and subdural hematoma with known manifestations
- Acute cervical spine injury
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
Nothing further to include that is not entered or uploaded elsewhere in the record
- Conditions
- Concussion
- Being tested
- Vestibular Rehabilitation, Traditional Protocol
- Keywords
- Vestibular Rehabilitation, Concussion, Dizziness, Balance Disturbances
- Medical subject headings
- Brain Concussion, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular RehabilitationOther
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 ProtocolOther
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
| Study group | Role | What they receive |
|---|---|---|
| Vestibular Rehabilitation | Experimental | This arm of the study received the vestibular rehabilitation treatment in addition to following traditional protocol. Receives: Other: Vestibular Rehabilitation |
| Traditional Treatment | Active comparator | This arm of the study received the traditional protocol in a stepwise progression only. Receives: Other: Traditional Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start25 Aug 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConcussionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Marschner
- Sponsor type
- University, hospital or other
- Collaborators
- Minot State University
- Responsible party
- Sponsor-investigator, Beth Marschner, Minot State University
- Investigators
- Beth Marschner, DPT, Principal investigator, Minot State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700252
- Sponsor's protocol ID
- 2133
- Status last verified
- Nov 2024
- First submitted
- 19 Sep 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vestibular Rehabilitation in the Treatment of Dizziness and Balance Disturbances After Concussion
- ClinicalTrials.gov ID
- NCT06700252
- Acronym / sponsor ID
- 2133
- Conditions
- Concussion
- Keywords
- Vestibular Rehabilitation, Concussion, Dizziness, Balance Disturbances
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Beth MarschnerUniversity, hospital or other
- Collaborators
- Minot State University
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vestibular Rehabilitation | Experimental | Other: Vestibular RehabilitationThis arm of the study received the vestibular rehabilitation treatment in addition to following traditional protocol. |
| Traditional Treatment | Active comparator | Other: Traditional ProtocolThis arm of the study received the traditional protocol in a stepwise progression only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Acute spinal cord injury with neurological deficits
- Epidural and subdural hematoma with known manifestations
- Acute cervical spine injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular RehabilitationThis 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. | Other | Vestibular Rehabilitation |
| Traditional ProtocolThis 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 | Other | Traditional Treatment |
Primary outcome
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.
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.
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth Marschner, DPT principal investigator
Minot State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Rehabilitation and Traditional Protocol in people with Concussion, run by Beth Marschner at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Gait Index (time frame: Up to 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.