NCT03215082

Brief Summary

The aim of this research program is to 1) Evaluate potential problems with vision, inner ear-eye reflexes and deficits of processing eye information that occur following TBI; and 2) Evaluate treatment programs for individuals with eye and inner ear problems that persist for greater than 10 days following injury. This study will include 465 youth and young adults (aged 6-30 years old) who sustain a TBI of any severity. An initial evaluative phase using the best available technology to evaluate eye and inner ear function will be performed, and compared with typical tests that are used in the clinic. If symptoms and functional problems remain 10 days after injury, participants will be randomly placed into a treatment group (including eye movement, inner ear-eye reflex and attention exercises as per our pilot studies) or a control group (typical rehabilitation). Success will be measured in terms of return to sport (mild TBI), achievement of goals (moderate and severe TBI) and quality of life. It is expected that this program will inform clinical practice and future research leading to a treatment program in TBI that includes multiple components.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
3 countries

4 active sites

Status
unknown

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

July 9, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 5, 2019

Status Verified

April 1, 2019

Enrollment Period

2.8 years

First QC Date

July 9, 2017

Last Update Submit

April 3, 2019

Conditions

Mild Traumatic Brain Injury; Concussion

Outcome Measures

Primary Outcomes (2)

  • PedsQL

    Pediatric and adult Quality of Life

    8 weeks post intervention initiation

  • Head Thrust Test

    Vestibulo-Ocular Reflex

    8 weeks post-intervention initiation

Study Arms (2)

Experimental

EXPERIMENTAL

The intervention will be an individualized impairment-based program based on a pre-determined sequence. A minimal intervention for all participants randomized to the intervention group at all sites will include general oculomotor and gaze stabilization retraining as tolerated. Intervention activities will be recorded and described in detail in a treatment log.

Other: Vestibular-Visual Intervention

Control

ACTIVE COMPARATOR

Standard care for mild TBI consists mainly of general education, energy conservation, academic adaptations, and restricting children and adolescents from participation in vigorous physical activities as well as complex cognitive activities until complete symptom resolution. It is the usual approach promoted by various associations and consensus groups. In addition, in all participating centers, children and teens requiring musculoskeletal approaches to address neck pain/dysfunction will receive it as indicated, based on the clinical judgment of the local team. Participants with moderate and severe TBI will also receive rehabilitation activities as planned in their respective centers. The standard care intervention will be recorded and described in detail in a treatment log.

Behavioral: standard care

Interventions

Vestibular-Visual InterventionOTHER

vestibular-visual exercises

Experimental
standard careBEHAVIORAL

standard care

Control

Eligibility Criteria

Age6 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Mild TBI or moderate-severe TBI will be included

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Sport Injury Prevention Research Centre, Faculty of Kinesiology, University of Calgary,

Calgary, Alberta, T2N 1N4, Canada

RECRUITING

Montreal Children's Hospital, MUHC

Montreal, Quebec, H4A3J1, Canada

RECRUITING

Service de Rééducation des Pathologies Neurologiques de l'Enfant - Pôle de Rééducation et Réadaptation de l'Enfant Hôpitaux de Saint Maurice

Saint-Maurice, 94410, France

RECRUITING

Department of Physical Therapy, School of Health Professions, Sackler Faculty of Medicine

Tel Aviv, Israel

RECRUITING

Related Publications (3)

  • Sorek G, Shaklai S, Gagnon I, Schneider K, Chevignard M, Stern N, Fadida Y, Kalderon L, Katz-Leurer M. Impact of Subarachnoid Hemorrhage on the Cardiac Autonomic Function During Rehabilitation in Children After Severe Traumatic Brain Injury. Neurotrauma Rep. 2023 Jul 14;4(1):458-462. doi: 10.1089/neur.2023.0032. eCollection 2023.

    PMID: 37475976DERIVED

  • Sorek G, Gagnon I, Schneider K, Chevignard M, Stern N, Fadida Y, Kalderon L, Shaklai S, Katz-Leurer M. The Cardiac Autonomic Response Recovery to the Modified Tilt Test in Children Post Moderate-Severe Traumatic Brain Injury. Brain Inj. 2022 Jul 3;36(8):1033-1038. doi: 10.1080/02699052.2022.2110942. Epub 2022 Aug 15.

    PMID: 35971307DERIVED

  • Sorek G, Gagnon I, Schneider K, Chevignard M, Stern N, Fadida Y, Kalderon L, Shaklai S, Katz-Leurer M. The integrated functions of the cardiac autonomic and vestibular/oculomotor systems in adolescents following severe traumatic brain injury and typically developing controls. Brain Inj. 2020 Sep 18;34(11):1480-1488. doi: 10.1080/02699052.2020.1807055. Epub 2020 Aug 18.

    PMID: 32809873DERIVED

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

Central Study Contacts

Isabelle Gagnon, PhD

CONTACT

514-412-4400Isabelle.gagnon8@mcgill.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Scientist

Study Record Dates

First Submitted

July 9, 2017

First Posted

July 12, 2017

Study Start

January 1, 2018

Primary Completion

October 1, 2020

Study Completion

December 1, 2020

Last Updated

April 5, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)FR(1)IL(1)