Cervico-vestibular Rehabilitation for Mild Traumatic Brain Injury

NCT03677661 | Completed

• 1 other identifier: Quebec mTBI
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Neck pain, dizziness and headache are common symptoms following mild traumatic brain injury (mTBI). The efficacy of cervical spine and vestibular-ocular system impairments intervention need to be determined. In this randomized clinical trial, a 6-week personalized clinical rehabilitation program on subacute mTBI will be compare to a conventional approach. The rehabilitation program will include cervical spine exercise combined with manual therapy as well as vestibular-ocular rehabilitation. Overall symptoms will be measured by the Post-Concussion Symptoms Scale (PCSS). Disability and symptoms severity related with neck pain, headache and dizziness will also be evaluated after the treatment period and at 6-week post-treatment.

Conditions

Post-Concussion Syndrome; Mild Traumatic Brain Injury; Vestibular Disorder; Whiplash Injuries; Concussion, Brain

Keywords

Concussion; Physical therapy; Vestibular rehabilitation; Mild traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• Post-Concussion Symptoms Scale (PCSS)

  The severity and impact of symptoms will be measured by a self-reported scale, the PCSS. This scale is a list of 22 symptoms for which participant rate each symptom for severity on a 0 (none) to 6 (severe) numerical scale. The maximum possible score is 132 (22 x 6 = 132). This valid and reliable scale has a minimal detectable change (90% confidence interval) of 12.3 PCSS points. Normative values have been established. The symptoms list can be divided in four main sub-groups (physical, cognitive, emotional and sleep disorders) and analysed accordingly.

  26 weeks post-intervention

Secondary Outcomes (10)

• Numerical Pain Rating Scale (NPRS)

  26 week post-intervention

• Neck Disability Index (NDI)

  26 week post-intervention

• Headache Disability Inventory (HDI)

  26 week post-intervention

• Dizziness Handicap Inventory (DHI)

  26 week post-intervention

• Global Rating of Change

  26 week post intervention

Study Arms (2)

Conventional approach

ACTIVE COMPARATOR

Graded aerobic exercise and advice for graded cognitive stimulation approach based on the 2016 Berlin consensus

Other: Conventional approach

Personalized rehabilitation program

EXPERIMENTAL

Cervico-vestibular rehabilitation personalized patient-centered clinical program combined with the exercise and advice of the conventional approach

Other: Personalized rehabilitation program

Interventions

Conventional approach OTHER

The intervention will consist of light cognitive and physical activity with no symptoms exacerbation followed by graded exertion. Participant will be evaluated by a neuropsychologist. The neuropsychological intervention will consist of advice relative to cognitive rest in line with the clinical evaluation results followed by an individualized step-by-step graded exposition to cognitive stimulus according to symptoms evolution. A kinesiologist will also evaluate the symptoms response to cardio-vascular exertion. According to the result of this clinical evaluation, a graded physical exercise program will be given to the participants. 8 in-clinic cardio-vascular exercise sessions in a 6-week period supervised by the kinesiologist (30 to 45 minutes each session) will be provided.

Conventional approach

Personalized rehabilitation program OTHER

The same advice and exercise program than the active comparator group will be provided. However, 2 physiotherapists will provide 8 treatment session ( 30 to 45 minutes). One physiotherapist will initially evaluate the physical dysfunctions associated to mTBI with a standardized evaluation to build the treatment plan. He will provide cervical manual therapy and therapeutic exercises based on the best current clinical approach and according to the impairment specifically found initially. A vestibular physiotherapist will provide treatment of canalith repositioning manoeuvre, vestibular adaptation, ocular motor exercises, balance and/or habituation exercises. This treatment will be adapted to the individual patient. No more than 8 sessions will be delivered.

Personalized rehabilitation program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 18 and 65 years of age;
• Sustained a mTBI in the past 3 to 12 weeks;
• Having ongoing post-concussion symptoms from the list in the PCSS that started 72 hours or less after an impact;
• Having felt at least one or more cognitive symptoms that started 72 hours or less after an impact;
• Having abnormalities on one of the following test : the cervical physical examination (eg, tenderness/spasm on segmental testing, or reduced motion), the vestibular evaluation (eg, Dix hallpike test, vestibulo-ocular reflex test, or head thrust test) or the ocular motor evaluation (eg, convergence, smooth visual pursuits, or saccades).

You may not qualify if:

• Patients with more than 30 minutes of loss of consciousness for the current episode;
• Patients with more than 24 hours of post-traumatic amnesia;
• Glasgow Coma Scale score lower than 14 at the time of injury;
• Patients with radiographic evidence of subdural hemorrhage, epidural hemorrhage, intraparenchymal hemorrhage, and cerebral or cerebellar contusion;
• Post-injury hospitalization for more than 48 hours;
• Fracture (head, neck and spine);
• Having a neurological condition, other than the actual mTBI;
• Having a cognitive or behavioural impairment with participation in the study;
• Have had general anesthesia during the three-month period prior to the study;
• Having received physiotherapy tretament for the currwnt episode.

Sponsors & Collaborators

• Laval University: lead
• Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale: collaborator
• Université du Québec à Trois-Rivières: collaborator

Study Sites (1)

Clinique Cortex

Québec, Quebec, G1W 0C5, Canada

Location

Related Publications (2)

• Langevin P, Fremont P, Fait P, Dube MO, Roy JS. Moving from the clinic to telehealth during the COVID-19 pandemic - a pilot clinical trial comparing in-clinic rehabilitation versus telerehabilitation for persisting symptoms following a mild Traumatic brain injury. Disabil Rehabil. 2024 Jun;46(13):2880-2889. doi: 10.1080/09638288.2023.2236016. Epub 2023 Jul 19.

  PMID: 37466379 DERIVED

• Langevin P, Fait P, Fremont P, Roy JS. Cervicovestibular rehabilitation in adult with mild traumatic brain injury: a randomised controlled trial protocol. BMC Sports Sci Med Rehabil. 2019 Nov 11;11:25. doi: 10.1186/s13102-019-0139-3. eCollection 2019.

  PMID: 31737275 DERIVED

MeSH Terms

Conditions

Post-Concussion Syndrome; Brain Concussion; Vestibular Diseases; Whiplash Injuries

Condition Hierarchy (Ancestors)

Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neck Injuries

Study Officials

• Jean-Sébastien Roy, pht, PhD

  Professor

  STUDY DIRECTOR

• Pierre Frémont, MD PhD

  Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professeur de Clinique

Study Record Dates

• First Submitted: September 15, 2018
• First Posted: September 19, 2018
• Study Start: April 1, 2019
• Primary Completion: April 1, 2021
• Study Completion: December 31, 2021
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Available
• Access Criteria: https://pubmed.ncbi.nlm.nih.gov/31737275/ https://pubmed.ncbi.nlm.nih.gov/35102743/

Locations

CA (1)