Effects of Early Vestibular Rehabilitation in Patients With Dizziness and Balance Disorders After Sport Concussion

NCT ID: NCT02945605

Last Updated: 2018-05-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-09
• Study Completion Date: 2017-03-21

Brief Summary

This study examines the effect of early vestibular rehabilitation on reducing physical post-concussion symptoms (e.g. dizziness, balance problems) and improving the timeline to achieve medical clearance to return to activities such as sports and work activities. Half of the participants will receive early vestibular rehabilitation added to standard of care, while the other half will receive standard of care only.

Detailed Description

As awareness of concussion and the numbers of reported concussions increase every year in the last few years, so does the need for more effective treatment strategies. Concussions can lead to a variety of symptoms that may last from days to weeks after injury.[1] Dizziness and vestibular impairments are prevalent in up to 81% of patients after concussion.[2,3] Additionally, dizziness and vestibular impairments are predictive of prolonged recovery times after concussion.[4] Although there are few studies suggesting that vestibular rehabilitation after concussion is promising,[5,6] there continues to be a void in well-controlled studies verifying that vestibular rehabilitation can be used to treat patients with dizziness and balance disorders after concussion. Due to the lack of controlled studies and current practice patterns, patients with concussions are not seen for physical therapy until weeks or months after their injury. The purpose of this study is to examine the effect of early vestibular rehabilitation on reducing physical post-concussion symptoms (e.g. dizziness, balance problems), and improving the timeline to achieve medical clearance to return to activities such as sports and work activities, when compared to STANDARD care. The findings of this study are expected to provide medical and sports related professionals with appropriate concussion treatment strategies and improve outcomes of patients suffering from concussion.

Conditions

Brain Concussion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Early Vestibular Rehabilitation

Participants in this group will receive a customized vestibular rehabilitation program designed and implemented by a vestibular physical therapist. The vestibular physical therapy must be initiated within 72 hours after randomization. Participants in this group will continue to receive standard of care treatment as directed by their physician.

Group Type: EXPERIMENTAL

Early Vestibular Rehabilitation

Intervention Type: OTHER

Two visits/week for a maximum of 5 weeks will be provided with the approximate duration for each visit estimated at 50-60 minutes. Consistent with a previously validated framework for exercise prescription in patients with concussion, the exercises provided by the treating therapist can be classified into five main exercise categories:

1. Eye-Head coordination, gaze stability and convergence exercises

2. Sitting balance

3. Standing static balance (i.e. feet-in-place)

4. Dynamic balance (feet moving, but not walking)

5. Ambulation (gait exercises)

6. Other exercises: Sport specific exercises, Canalith repositioning maneuvers are recorded as others

Standard of Care

Intervention Type: OTHER

Standard care as directed by a physician.

Standard of Care

Participants in this group will receive standard care as directed by their physician.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Standard care as directed by a physician.

Interventions

Early Vestibular Rehabilitation

Two visits/week for a maximum of 5 weeks will be provided with the approximate duration for each visit estimated at 50-60 minutes. Consistent with a previously validated framework for exercise prescription in patients with concussion, the exercises provided by the treating therapist can be classified into five main exercise categories:

1. Eye-Head coordination, gaze stability and convergence exercises

2. Sitting balance

3. Standing static balance (i.e. feet-in-place)

4. Dynamic balance (feet moving, but not walking)

5. Ambulation (gait exercises)

6. Other exercises: Sport specific exercises, Canalith repositioning maneuvers are recorded as others

Intervention Type: OTHER

Standard of Care

Standard care as directed by a physician.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Dizziness or balance problems within 10 days of concussion

Exclusion Criteria

• None

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Bara Alsalaheen, PT, Ph.D.

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bara Alsalaheen, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan Health System

Ann Arbor, Michigan, United States

Countries

United States

References

Broglio SP, Cantu RC, Gioia GA, Guskiewicz KM, Kutcher J, Palm M, Valovich McLeod TC; National Athletic Trainer's Association. National Athletic Trainers' Association position statement: management of sport concussion. J Athl Train. 2014 Mar-Apr;49(2):245-65. doi: 10.4085/1062-6050-49.1.07. Epub 2014 Mar 7.

Reference Type: BACKGROUND

PMID: 24601910 (View on PubMed)

Zhou G, Brodsky JR. Objective vestibular testing of children with dizziness and balance complaints following sports-related concussions. Otolaryngol Head Neck Surg. 2015 Jun;152(6):1133-9. doi: 10.1177/0194599815576720. Epub 2015 Mar 27.

Reference Type: BACKGROUND

PMID: 25820582 (View on PubMed)

Corwin DJ, Wiebe DJ, Zonfrillo MR, Grady MF, Robinson RL, Goodman AM, Master CL. Vestibular Deficits following Youth Concussion. J Pediatr. 2015 May;166(5):1221-5. doi: 10.1016/j.jpeds.2015.01.039. Epub 2015 Mar 5.

Reference Type: BACKGROUND

PMID: 25748568 (View on PubMed)

Lau BC, Kontos AP, Collins MW, Mucha A, Lovell MR. Which on-field signs/symptoms predict protracted recovery from sport-related concussion among high school football players? Am J Sports Med. 2011 Nov;39(11):2311-8. doi: 10.1177/0363546511410655. Epub 2011 Jun 28.

Reference Type: BACKGROUND

PMID: 21712482 (View on PubMed)

Alsalaheen BA, Mucha A, Morris LO, Whitney SL, Furman JM, Camiolo-Reddy CE, Collins MW, Lovell MR, Sparto PJ. Vestibular rehabilitation for dizziness and balance disorders after concussion. J Neurol Phys Ther. 2010 Jun;34(2):87-93. doi: 10.1097/NPT.0b013e3181dde568.

Reference Type: BACKGROUND

PMID: 20588094 (View on PubMed)

Schneider KJ, Meeuwisse WH, Nettel-Aguirre A, Barlow K, Boyd L, Kang J, Emery CA. Cervicovestibular rehabilitation in sport-related concussion: a randomised controlled trial. Br J Sports Med. 2014 Sep;48(17):1294-8. doi: 10.1136/bjsports-2013-093267. Epub 2014 May 22.

Reference Type: BACKGROUND

PMID: 24855132 (View on PubMed)

Other Identifiers

HUM00109407

Identifier Type: -

Identifier Source: org_study_id