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Seeing-Moving-Playing: Early Rehabilitation Utilizing Visual and Vestibular Technology Following Traumatic Brain Injury (SiMPlyRehab)

Primary Purpose

Mild Traumatic Brain Injury; Concussion

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Vestibular-Visual Intervention
standard care
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Traumatic Brain Injury; Concussion

Eligibility Criteria

6 Years - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Mild TBI or moderate-severe TBI will be included

Exclusion Criteria:

-

Sites / Locations

  • Sport Injury Prevention Research Centre, Faculty of Kinesiology, University of Calgary,Recruiting
  • Montreal Children's Hospital, MUHCRecruiting
  • Service de Rééducation des Pathologies Neurologiques de l'Enfant - Pôle de Rééducation et Réadaptation de l'Enfant Hôpitaux de Saint MauriceRecruiting
  • Department of Physical Therapy, School of Health Professions, Sackler Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

PedsQL
Pediatric and adult Quality of Life
Head Thrust Test
Vestibulo-Ocular Reflex

Secondary Outcome Measures

Full Information

First Posted
July 9, 2017
Last Updated
April 3, 2019
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03215082
Brief Title
Seeing-Moving-Playing: Early Rehabilitation Utilizing Visual and Vestibular Technology Following Traumatic Brain Injury
Acronym
SiMPlyRehab
Official Title
Seeing-Moving-Playing: Early Rehabilitation Utilizing Visual and Vestibular Technology Following Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury; Concussion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Vestibular-Visual Intervention
Intervention Description
vestibular-visual exercises
Intervention Type
Behavioral
Intervention Name(s)
standard care
Intervention Description
standard care
Primary Outcome Measure Information:
Title
PedsQL
Description
Pediatric and adult Quality of Life
Time Frame
8 weeks post intervention initiation
Title
Head Thrust Test
Description
Vestibulo-Ocular Reflex
Time Frame
8 weeks post-intervention initiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Mild TBI or moderate-severe TBI will be included Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle Gagnon, PhD
Phone
514-412-4400
Ext
23896
Email
Isabelle.gagnon8@mcgill.ca
Facility Information:
Facility Name
Sport Injury Prevention Research Centre, Faculty of Kinesiology, University of Calgary,
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn Schneider, PhD
Phone
403-210-8951
Email
kjschnei@ucalgary.ca
Facility Name
Montreal Children's Hospital, MUHC
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Gagnon, PhD
Phone
514-412-4400
Ext
23896
Email
isabelle.gagnon8@mcgill.ca
Facility Name
Service de Rééducation des Pathologies Neurologiques de l'Enfant - Pôle de Rééducation et Réadaptation de l'Enfant Hôpitaux de Saint Maurice
City
Saint-Maurice
ZIP/Postal Code
94410
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathilde Chevignard, PhD
Phone
01 43 96 63 40
Email
m.chevignard@hopitaux-stmaurice.fr
Facility Name
Department of Physical Therapy, School of Health Professions, Sackler Faculty of Medicine
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michal Katz-Leurer, PhD
Phone
97236405432
Email
michalkz@post.tau.ac.il

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35971307
Citation
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.
Results Reference
derived
PubMed Identifier
32809873
Citation
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.
Results Reference
derived

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Seeing-Moving-Playing: Early Rehabilitation Utilizing Visual and Vestibular Technology Following Traumatic Brain Injury

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