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Cervico-vestibular Rehabilitation for Mild Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT03677661
Recruitment Status : Not yet recruiting
First Posted : September 19, 2018
Last Update Posted : September 20, 2018
Sponsor:
Collaborators:
Centre interdisciplinaire de recherche en réadaptation et intégration sociale
Université du Québec à Trois-Rivières
Information provided by (Responsible Party):
Pierre Langevin, Laval University

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.

Condition or disease Intervention/treatment Phase
Post-Concussion Syndrome Mild Traumatic Brain Injury Vestibular Disorder Whiplash Injuries Concussion, Brain Other: Conventional approach Other: Personalized rehabilitation program Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cervico-vestibular Rehabilitation for Mild Traumatic Brain Injury — A Randomized Clinical Trial
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Conventional approach
Graded aerobic exercise and advice for graded cognitive stimulation approach based on the 2016 Berlin consensus
Other: Conventional approach
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.

Experimental: Personalized rehabilitation program
Cervico-vestibular rehabilitation personalized patient-centered clinical program combined with the exercise and advice of the conventional approach
Other: Personalized rehabilitation program
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.




Primary Outcome Measures :
  1. Post-Concussion Symptoms Scale (PCSS) [ Time Frame: 6 week post-intervention ]
    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.


Secondary Outcome Measures :
  1. Clearance to return to function [ Time Frame: 6 week post-intervention ]
    The number of days between the initial evaluation and the full clearance to return to function will be measured. The clearance to return to function will be determined by the treating therapist and the neuropsychologist. The treating therapist will use the stepwise progression of the 5th International Consensus Statement on Sport Concussion. When the patient will achieve the last step of this progression which means that the patient can safely return to play, the neuropsychologist and the kinesiologist will confirm the decision with a structured interview (neuropsychologist) and an aerobic test (kinesiologist). The clearance will be determined by the day for which 1) the symptoms will have resolved 2) the neurological, cervical spine and vestibular exams will be deemed normal by the treating physiotherapist 3) the subject returned to his normal level of all functional activities.

  2. Numerical Pain Rating Scale (NPRS) [ Time Frame: 6 week post-intervention ]
    The level of neck pain and headache will be captured separately with NPRS. Using an 11-point scale, ranging from 0 (no pain) to 10 (worst pain imaginable), participants will be asked to answer the following question: "On a scale of 0 to 10, where 0 corresponds to no pain and 10 to the worst imaginable pain, evaluate the intensity of your neck pain at this moment". The same question will be asked for the headache. The NPRS is moderately reliable (ICC = 0.76) and has a clinically important difference of 13%.

  3. Neck Disability Index (NDI) [ Time Frame: 6 week post-intervention ]
    The NDI is a 10-item questionnaire that measures a patient's self-reported neck pain related disability. Questions include pain and activities of daily living. The questions are measured on a six-point scale from 0 (no disability) to 5 (full disability). The numeric response for each item is summed for a total score ranging from 0 to 50. The reliability (Intraclass Correlation Coefficient [ICC]: 0.73 to 0.98), construct validity, and responsiveness to change have all been demonstrated in various populations. The validated French version NDI will be used.

  4. Headache Disability Inventory (HDI) [ Time Frame: 6 week post-intervention ]
    The HDI is a 25-item questionnaire measuring the disability related to patient reported headache. Questions include activities of daily living and perceived disability as measured with an ordinal scale (yes (4 points), sometimes (2 points), no (0 point)). After adding every numerical score, the total score is on 100 for which 0 means no disability and 100 complete disability. The test-retest reliability (r=0,79 to 0,83) and the minimal detectable change (16 points) are known.

  5. Dizziness Handicap Inventory (DHI) [ Time Frame: 6 week post-intervention ]
    The DHI is a 25-items questionnaire. The items are sub grouped into three content domains representing functional, emotional, and physical aspects of dizziness and unsteadiness. The purpose of this scale is to identify difficulties that the patient may be experiencing because of dizziness or unsteadiness. The questionnaire demonstrated high Test-retest reliability (r = 0.92 to 0.97) and internal consistency (α = 0.72 to 0.89).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Over 18 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).

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677661


Contacts
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Contact: Pierre Langevin, pht, MClSc 418-955-7853 pierre.langevin@fmed.ulaval.ca
Contact: Philippe Fait, PhD 819-376-5011 ext 3768 philippe.fait@uqtr.ca

Locations
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Canada, Quebec
Clinique Cortex Not yet recruiting
Quebec city, Quebec, Canada, G1W 0C5
Contact: Pierre Langevin, pht, MClSc    418-955-7853    pierre.langevin@fmed.ulaval.ca   
Sponsors and Collaborators
Laval University
Centre interdisciplinaire de recherche en réadaptation et intégration sociale
Université du Québec à Trois-Rivières
Investigators
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Study Director: Jean-Sébastien Roy, pht, PhD Professor
Study Director: Pierre Frémont, MD PhD Professor

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Responsible Party: Pierre Langevin, Professeur de Clinique, Laval University
ClinicalTrials.gov Identifier: NCT03677661     History of Changes
Other Study ID Numbers: Quebec mTBI
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pierre Langevin, Laval University:
Concussion
Physical therapy
Vestibular rehabilitation
Mild traumatic brain injury

Additional relevant MeSH terms:
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Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Whiplash Injuries
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating
Neck Injuries
Post-Concussion Syndrome
Vestibular Diseases
Central Nervous System Diseases
Nervous System Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases