NCT02945605

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

March 9, 2017

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2017

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

12 days

First QC Date

October 24, 2016

Last Update Submit

May 25, 2018

Conditions

Brain Concussion

Outcome Measures

Primary Outcomes (1)

  • Change in Sports Concussion Assessment Tool (SCATIII) Symptom Inventory

    The change is calculated by subtracting the score obtained at a designated time point from the initial score.

    At every 7 days since concussion and the end of the study (up to 5 weeks, or after full resolution of symptoms, whichever occurs first)

Secondary Outcomes (9)

  • Change in Dizziness Handicap Inventory (DHI)

    At every 7 days since concussion and the end of the study (up to 5 weeks, or after full resolution of symptoms, whichever occurs first)

  • Global Rating of Change (GRC)

    At every 7 days since concussion and the end of the study (up to 5 weeks, or after full resolution of symptoms, whichever occurs first)

  • Change in Vestibular Ocular Motor Screening (VOMS)

    Up to 5 weeks, or after full resolution of symptoms, whichever occurs first

  • Change in Functional Gait Assessment (FGA)

    Up to 5 weeks, or after full resolution of symptoms, whichever occurs first

  • Change in Original and Cognitive Timed Up & Go (TUG)

    Up to 5 weeks, or after full resolution of symptoms, whichever occurs first

  • +4 more secondary outcomes

Study Arms (2)

Early Vestibular Rehabilitation

EXPERIMENTAL

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.

Other: Early Vestibular RehabilitationOther: Standard of Care

Standard of Care

ACTIVE COMPARATOR

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

Other: Standard of Care

Interventions

Early Vestibular RehabilitationOTHER

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

Early Vestibular Rehabilitation
Standard of CareOTHER

Standard care as directed by a physician.

Early Vestibular RehabilitationStandard of Care

Eligibility Criteria

Age14 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Dizziness or balance problems within 10 days of concussion

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (6)

  • 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.

    PMID: 24601910BACKGROUND

  • 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.

    PMID: 25820582BACKGROUND

  • 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.

    PMID: 25748568BACKGROUND

  • 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.

    PMID: 21712482BACKGROUND

  • 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.

    PMID: 20588094BACKGROUND

  • 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.

    PMID: 24855132BACKGROUND

MeSH Terms

Conditions

Brain Concussion

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Bara Alsalaheen, PT, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 24, 2016

First Posted

October 26, 2016

Study Start

March 9, 2017

Primary Completion

March 21, 2017

Study Completion

March 21, 2017

Last Updated

May 30, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)