Cervico-vestibular Rehabilitation for Mild Traumatic Brain Injury
Condition: Post-Concussion Syndrome; Mild Traumatic Brain Injury; Vestibular Disorder; Whiplash Injuries; Concussion, Brain
MeSH terms: Vestibular Diseases; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Post-Concussion Syndrome; Wounds and Injuries; Whiplash Injuries
Study type: Interventional

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.
    

Detailed description: 
      BACKGROUND

      Mild traumatic brain injury (mTBI) is an acknowledged public health problem. It is estimated
      that between 1.6 to 3.8 million brain injuries occur annually in the United States, with up
      to 75% classified as mild. The majority of mTBI resolves within 10 to 14 days. However, up to
      31% of pediatric cases and 25% of adult cases present post concussive syndrome (PCS), which
      is a persistence of somatic (for example: headache, neck pain, dizziness, nausea, balance
      dysfunction), cognitive (for example: memory loss and slowed reaction time), and/or
      psychological (for example: depression and anxiety) symptoms. Among these symptoms, headache
      and dizziness are the most commonly reported, followed by nausea and neck pain. Many of these
      PCS symptoms could be explained by injuries to structures near or in the head, other than the
      brain itself. For example, following a trauma, structures such as the cervical spine, the
      vestibular ocular system and the temporomandibular joint can be injured. The energy needed to
      produce an mTBI can be transferred to the neck and produce an injury mechanism similar to the
      one observed in whiplash associated disorders (WAD). Neck pain, headaches, dizziness and
      balance dysfunction are common symptoms associated with both mTBI and WAD. Specific
      interventions for these injuries are therefore needed when present.

      For individuals presenting persistent post-concussion symptoms, the most recent international
      consensus statement (2017 Berlin consensus on concussion in sport) recommends the addition of
      an individualized rehabilitation approach to the usual rest and sub-symptoms gradual
      activation strategies. However, this new recommendation is based on weak evidence as well as
      expert recommendations. Therefore, the effects of adding individualized rehabilitation
      interventions for the treatment of potential impairments of body function associated with
      neck pain, headache and dizziness, needs to be evaluated in individuals with mTBI. The
      treatment of neck pain, cervicogenic headache, dizziness and balance dysfunction with
      multimodal rehabilitation interventions or vestibular rehabilitation has been demonstrated
      effective in several systematic and Cochrane reviews; however none of the randomized control
      trials (RCT) included in these reviews included individuals with mTBI. Two RCTs have
      partially looked at the effects of rehabilitation interventions in some subgroups of mTBI
      patients. One RCT (n=31) has demonstrated that patients with sport-related concussion treated
      with a standardized combination of vestibular and cervical physiotherapy were quicker to be
      medically cleared to return to sport than a control group who was resting and gradually
      returning to activities. However, the intervention used in that study was not individualized
      to the specific impairments of the participants. Another RCT recruited 41 sport-related
      concussion patients with dizziness as the main symptom and found that a rehabilitation
      treatment targeting dizziness was more effective in terms of time to medical clearance than a
      minimal intervention (subtherapeutic and non-progressive therapeutic techniques). However, as
      a most likely multifactorial condition, mTBI treatments arguably need to be individualized to
      the patient's clinical presentation and the outcomes need to encompass all types of symptoms.
      In that context, there is a need for further RCTs evaluating the effect of a personalized
      patient-centered rehabilitation approach (based on the Berlin consensus) on mTBI.

      Objectives and hypothesis: The primary objective of the current RCT is to compare the
      addition of a 6-week personalized patient-centered clinical rehabilitation program to a
      conventional approach in adults with subacute (> than 3 weeks post TBI) headache, neck pain
      and /or dizziness-related to mTBI on the severity and impact of symptoms as measured by the
      Post-Concussion Symptoms Scale (PCSS). The secondary outcomes will be: clearance to return to
      usual activities, number of recurrence episode, functional level, neck pain, headache and
      dizziness. Our hypothesis is that the personalized patient-centered clinical rehabilitation
      program will improve overall symptoms, time to return to activities as well as function
      faster than the conventional approach and between group differences will be observed at week
      6, 12 and 26.

      METHODS

      Study Design: This single-blind, parallel-group RCT will include 8 supervised treatments
      during a 6-week rehabilitation program (2 sessions/week the first 2 weeks, then 1
      session/week for the last 4 week) and four evaluation sessions over 26 weeks (baseline, week
      6 [immediately after the rehabilitation program], week 12 [6 week after the end of the
      rehabilitation program] and week 26). All participants will take part in the baseline
      evaluation. After giving an informed consent, they will first complete a questionnaire on
      sociodemographic (age, gender, type of sport or physical activities, number of years playing
      sport and/or other activities), symptomatology (mechanism of injury, history of previous
      mTBI, history of dizziness, headache, neck pain and unsteadiness) and comorbidity, as well as
      self-administered questionnaires that evaluate symptoms and functional limitations, including
      the PCSS (primary outcome). Once baseline data collected, participants will be randomly
      assigned to the control or intervention group. The control group will receive a the 6-week
      conventional intervention based on sub-symptoms gradual cardio-vascular exercise program. The
      experimental group will receive a 6-week personalized patient-centered clinical
      rehabilitation program in addition to the same intervention as the control group. Between
      week 6 and week 12, participants will be asked to continue their exercises and follow the
      advice given at the last meeting with the health professional. Six, 12 and 26 weeks after
      randomization, all the outcomes will be revaluated. The evaluation sessions will be carried
      out at the Centre interdisciplinaire de recherche en réadaptation et en intégration sociale
      (CIRRIS) by a research assistant blinded to group assignment, while the interventions will be
      given at Clinique Cortex by experienced physiotherapists, neuropsychologists and
      kinesiologists.

      Population: 46 adults presenting to the Clinique Cortex (Concussion clinic) with a diagnosis
      of mTBI (based on the definition of the Berlin 2016 international consensus statement) and
      persistent symptoms of dizziness, neck pain and/or headaches (reported on the PCSS)17 lasting
      for more than 3 weeks will be recruited. The reported symptoms must 1) have started in the
      first 72 hours following an impact, 2) include one or more cognitive symptom(s), as found in
      the PCSS).

      Sample size calculation is based on changes evidenced by the PCSS for individuals with mTBI.
      According to sample size calculation (G*Power 3.1.9.2; α=0.05, effect size=0.8, power
      [1-β]=0.80, Standard Deviation(SD)=20.0 PCSS points, Minimal Detectable Change (MDC)=12.3
      PCSS points, 10% attrition), a minimum of 23 patients are needed in each group. Therefore, 46
      participants with mTBI will be recruited.

      Inclusion and exclusion criteria are described elsewhere in the form.

      Randomisation/Blinding: A randomisation list will be generated by an independent research
      assistant (not involved in data collection) prior to the initiation of the study using a
      random number generator. Allocation will be concealed in sealed and opaque envelopes that
      will be sequentially numbered. A blocked randomisation will be used to make sure that two
      equal groups of 23 participants are obtained. Stratification will be done according to sex to
      ensure women and men are equally represented in each group as it has been shown that women
      tend to recover more slowly than man from a mTBI. Given that it is not possible to blind the
      treating physiotherapist and the participants, a single-blind design will be used as only the
      evaluator will be blinded. One of the Principal Investigator (PI) will open the randomisation
      envelope indicating the participant's assignment and will send the information to the
      treating therapist. The physiotherapists, neuropsychologists and the kinesiologists will be
      blinded to the baseline evaluation results. To evaluate the effectiveness of blinding, the
      evaluator will complete a question related to her/his opinion of the allocation. Participants
      will be unaware of the treatment provided to other participants. Participants will be
      instructed not to reveal or discuss treatment with the evaluator. To assess blinding
      effectiveness, the evaluator will answer the following question at the week-6 evaluation: "In
      your opinion, which intervention this participant received?" The possible answers are: 1)
      conventional (comparison group); 2) intervention testing the personalized patient-centered
      clinical rehabilitation program (experimental group); 3) I have no idea.

      The outcome measures are well described elsewhere in the form.

      Statistical Analyses: Descriptive statistics will be used for all outcome measures at each
      measurement time to summarize results. Baseline demographic data will be compared
      (independent t-test and Chi-squared tests) to establish the comparability of groups. All data
      will be tested to check the distributional assumptions for the inferential statistical
      analyses. An intention-to-treat analysis will be used in which all participants will be
      analysed in the group to which they were originally assigned. Per protocol analysis will also
      be performed. All dropouts and the reason for dropping out of the study will be reported. Any
      harm or unintended effects during the programs will be recorded. A 2-way ANOVA (2 Groups
      [Group 1 or 2] x 4 Time [week 0, 6, 12, 26]) will be used to analyse the effects of the
      rehabilitation programs on the primary outcome and on most of the secondary outcomes (SPSS
      22, proc GENLIN). We expect no group effects, as the groups should be equal at baseline. A
      time effect should be observed, as both groups should improve given they will both receive an
      interventions. Finally, we expect a significant Time x Group interaction since the groups
      should react differently over time, with a faster recovery for the Experimental group seen at
      week 6 and 12. This will be statistically detailed with post-hoc tests (Bonferroni
      correction). An independent t-test will be used to analyse the effects of the rehabilitation
      programs on clearance to return to function.
    

Intervention name(s): Conventional approach; Personalized rehabilitation program
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Concussion; Physical therapy; Vestibular rehabilitation; Mild traumatic brain injury