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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03215082
Acronym
SiMPlyRehab
Enrollment
400
Registered
2017-07-12
Start date
2018-01-01
Completion date
2020-12-31
Last updated
2019-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Traumatic Brain Injury; Concussion

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.

Interventions

OTHERVestibular-Visual Intervention

vestibular-visual exercises

BEHAVIORALstandard care

standard care

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Mild TBI or moderate-severe TBI will be included

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
PedsQL8 weeks post intervention initiationPediatric and adult Quality of Life
Head Thrust Test8 weeks post-intervention initiationVestibulo-Ocular Reflex

Countries

Canada, France, Israel

Contacts

Primary ContactIsabelle Gagnon, PhD
Isabelle.gagnon8@mcgill.ca514-412-4400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026