Cervico-vestibular Rehabilitation for Mild Traumatic Brain Injury
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|ClinicalTrials.gov Identifier: NCT03677661|
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : November 4, 2019
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Cervico-vestibular Rehabilitation for Mild Traumatic Brain Injury — A Randomized Clinical Trial|
|Actual Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||April 1, 2020|
|Estimated Study Completion Date :||December 1, 2020|
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.
- Post-Concussion Symptoms Scale (PCSS) [ Time Frame: 26 weeks 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.
- Clearance to return to function [ Time Frame: immediately 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.
- Numerical Pain Rating Scale (NPRS) [ Time Frame: 26 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%.
- Neck Disability Index (NDI) [ Time Frame: 26 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.
- Headache Disability Inventory (HDI) [ Time Frame: 26 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.
- Dizziness Handicap Inventory (DHI) [ Time Frame: 26 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).
- Recurrence episodes [ Time Frame: 26 week post-intervention ]number of recurrence episodes calculated as the number of episodes of symptoms with a duration of at least 48 hours following a trauma during the 26 weeks of the study
- Global Rating of Change [ Time Frame: 26 week post intervention ]GRC questions are designed to quantify a patient's perceived improvement or deterioration over time. Using a 15-point GRC scale, ranging from -7 (a very great deal worse) to 0 (about the same) to +7 (a very great deal better), participants will be asked to answer the following question: " Overall, has there been any change in your condition since the initial evaluation? Please indicate if there has been any change in your condition by choosing one of the following options." The validity, reliability (ICC = 0.90) and responsiveness of GRC scales have been established.
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
|Contact: Pierre Langevin, pht, MClScemail@example.com|
|Contact: Philippe Fait, PhD||819-376-5011 ext firstname.lastname@example.org|
|Quebec city, Quebec, Canada, G1W 0C5|
|Contact: Pierre Langevin, pht, MClSc 418-955-7853 email@example.com|
|Study Director:||Jean-Sébastien Roy, pht, PhD||Professor|
|Study Director:||Pierre Frémont, MD PhD||Professor|