<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03771950</url>
  </required_header>
  <id_info>
    <org_study_id>470-18</org_study_id>
    <nct_id>NCT03771950</nct_id>
  </id_info>
  <brief_title>Early Team Based Neuro-rehabilitation After Traumatic Brain Injury - a Pilot Study</brief_title>
  <official_title>Early Team Based Neuro-rehabilitation After Traumatic Brain Injury - a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vastra Gotaland Region</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alingsas hospital emergincy section</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Narhalsan primary care rehabilitation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Narhalsan Reasearch and Development primary care Region Vastra Gotaland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Vastra Gotaland Region</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim is to evaluate the study design, procedure and measurements in a randomised&#xD;
      controlled pilot study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite that mild traumatic brain injury (mTBI) is a common condition managed in various&#xD;
      healthcare settings, early team based neurorehabilitation (TbNR) in post-concussion syndrom&#xD;
      (PCS) is sparely investigated. Therefore we aim to design a high quality randomised&#xD;
      controlled study (RCT) investigating the effect of early TbNR in PCS. Prior this RCT a pilot&#xD;
      study will be conducted with the aim to evaluate the study design, procedure and&#xD;
      measurements.&#xD;
&#xD;
      Method:&#xD;
&#xD;
      Thirty consecutive patients visiting Alingsås hospital emergency department due to head&#xD;
      injury caused by fall, trauma to the head, traffic accident or abuse, and diagnosed with&#xD;
      brain concussion (ICD10 S060, S0600) for the first time or after repeated trauma, will be&#xD;
      asked to participate in the study. The patient will receive a written study information when&#xD;
      discharged, and asked if an occupational therapist can contact the patient by phone for&#xD;
      further information and screening questions 14 days after trauma. If the patient meet the&#xD;
      inclusion criteria and wish to participate in the study a written informed consent will be&#xD;
      obtained.&#xD;
&#xD;
      Test procedure:&#xD;
&#xD;
      A structured interview and the assessment described below will be performed at baseline 3-4&#xD;
      weeks after the trauma and after 16 weeks by an occupational therapist. Participant's&#xD;
      characteristics such as age, gender, work ability, education, social status, previous trauma&#xD;
      to the head and known comorbidity are collected. The classification of the mTBI will be&#xD;
      collected from the patients' medical journal, as well as the result and time of the CT&#xD;
      examination if it has been performed. Information about previous sick leave will be collected&#xD;
      from the Swedish health insurance office. The number of visits to the occupational therapist&#xD;
      (OT) and the physiotherapist (PT) will be recorded from the participant's medical journal.&#xD;
&#xD;
      Study protocol In this pilot study we plan to evaluate broadly as the persons with mTBI may&#xD;
      suffer from a complex symptomatology, and the causes of persisting symptoms are unclear.&#xD;
&#xD;
      The following data will be collected:&#xD;
&#xD;
        -  The number of patients who meet the inclusion criteria.&#xD;
&#xD;
        -  The number of patients consenting participation in the study.&#xD;
&#xD;
        -  The number of patients completing questionnaires at baseline and post-test.&#xD;
&#xD;
        -  The number of patients who participate in the intervention.&#xD;
&#xD;
      Randomisation:&#xD;
&#xD;
      After screening for eligibility, fulfilling inclusion criteria and consenting to&#xD;
      participation the baseline assessment will be conducted by an OT at enrolment. After this the&#xD;
      patients will be randomised either to the intervention or control group in using lots in&#xD;
      sealed envelopes based on a computer generated group allocation. The lots are kept in sealed&#xD;
      envelopes prepared by a person not involved in the study. An OT will open the envelope and&#xD;
      inform the patient about group allocation. All care providers will be blinded for baseline&#xD;
      and post-test outcomes. A research co-worker who are involved in data management will be&#xD;
      blinded for group allocation.&#xD;
&#xD;
      Interventions:&#xD;
&#xD;
      The patients randomised to the intervention group (n=15) will be treated by the PT and OT in&#xD;
      TbNR. At the first visits a medical history will be taken, there after a structured interview&#xD;
      will be made by the OT about activity level, and an examination of the patients bodily and&#xD;
      neurological symptoms will be made by the PT. Based on this result a TbNR a rehabilitation&#xD;
      plan is established consisting of the patient's goals, and the purpose that the patient shall&#xD;
      be as active as possible without triggering symptoms. An individual exercise program is&#xD;
      prescribed. Number of visits to TbNR will depend on the individual need for rehabilitation.&#xD;
&#xD;
      Between each appointment with TbNR, the patient will have personal tasks to accomplish with&#xD;
      the purpose of being active based on symptoms and the adaptation to the current level of&#xD;
      energy. Information about underlying causes of perceived symptoms will be present at the&#xD;
      visits, and the patient will be given help to analyze the tasks that has been performed&#xD;
      during the past week. The perceived symptoms will be logged in an activity log including&#xD;
      estimation of fatigue and headache. A week-schedule will be created in the purpose of helping&#xD;
      the patient to a balanced activity level in relation to their current capacity.&#xD;
&#xD;
      The PT assesses physical activity level and reactions to physical strain. Adaptations are&#xD;
      made to the exercise program and advice is given on physical activity and exercises. When&#xD;
      appropriate the OT advices about returning to work and adaptations concerning work.&#xD;
&#xD;
      Control:&#xD;
&#xD;
      Participants will be treated as usual, which is that they can search health care by themself.&#xD;
&#xD;
      Statistics:&#xD;
&#xD;
      Ratio and interval data are presented as mean ± 1 standard deviation (SD), ordinal data are&#xD;
      presented as median, and 25th and 75th percentile, nominal data are presented in absolute and&#xD;
      relative numbers.&#xD;
&#xD;
      Change between baseline and post-test will be analyzed for each outcome measure and between&#xD;
      the groups. Depending if the data are normal distributed or not parametric or non-parametric&#xD;
      tests will be used for differences between group.&#xD;
&#xD;
      Effect sizes and 95% confidence intervals will be calculated. Cohen's d will be used to&#xD;
      estimate the effect size using mean difference between groups and pooled standard deviation&#xD;
      of the mean differences. The magnitude of effect size will be considered small for d = 0.2 -&#xD;
      0.49, medium for d = 0.5-0.79, and large for d = 0.8-1.1 (16).&#xD;
&#xD;
      Odds ratio will be used to estimate effect size for binary dependent variable using logistic&#xD;
      regression. Linear regression analysis will be used for change of outcome measurements&#xD;
      adjusting for gender, number of head trauma and if the injury has been caused by another&#xD;
      person or not. The Statistical Package for Social Science (SPSS) for Windows, Version 22.0,&#xD;
      2013. IBM Corp, Armonk, NY: USA will be used for statistical analyses. A p-value &lt; 0.05 is&#xD;
      considered statistical significant.&#xD;
&#xD;
      Sample size:&#xD;
&#xD;
      In the planned pilot study 30 participants will be enrolled. This sample size is considered&#xD;
      to be sufficient to analyze effect size for the included outcome measurements which will be&#xD;
      used for planning the full-scale randomized controlled study involving more emergency&#xD;
      hospitals and neuro teams.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>After screening for eligibility, fulfilling inclusion criteria and consenting to participation the baseline assessment will be conducted by an OT at enrolment. After this the patients will be randomised either to the intervention or control group in using lots in sealed envelopes based on a computer generated group allocation. The lots are kept in sealed envelopes prepared by a person not involved in the study. An OT will open the envelope and inform the patient about group allocation. All care providers will be blinded for baseline and post-test outcomes. A research co-worker who are involved in data management will be blinded for group allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Numbers of patients who meet the inclusion criteria and accept participation in the study?</measure>
    <time_frame>16 weeks after trauma</time_frame>
    <description>Count how many of the patients want to participate in the study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Numbers of participants who respond to the included measurements?</measure>
    <time_frame>16 weeks after trauma</time_frame>
    <description>Count the number</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numbers of participants who complete post-test?</measure>
    <time_frame>16 weeks after trauma</time_frame>
    <description>Count the number</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rivermead post-concussion symtoms questionnaire (Swedish version) (RPQ)</measure>
    <time_frame>Effect size of change from baseline to 16 weeks after trauma</time_frame>
    <description>A valid, reliable and established measurement of self-perceived symptoms after brain concussion. The measurement consists of 16 items concerning perceived headache, vertigo, nausea, sensitivity to sound, sleeping disorders, fatigue, irritability, depression, frustration, poor memory, poor concentration, longer time to think, blurred vision, sensitivity to light, double vision and restlessness the past 24 hours compared to before the head injury. The symptoms are assessed on a 5-pointscale: never had symptom (category 0), had symptoms but they resolved (category 1), had moderate problems with symptom (category 2), having moderate problems with symptom (category 3), having severe problem with symptom (category 4)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multidimensional Fatigue Inventory (MFI)</measure>
    <time_frame>Effect size of change from baseline to 16 weeks after trauma</time_frame>
    <description>A valid and reliable measurement consisting of 20 items to measure fatigue. Various dimensions are estimated such as general fatigue, physical fatigue, decreased activity, reduced motivation and mental fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity level is measured with GAP in everyday activity.</measure>
    <time_frame>Effect size of change from baseline to 16 weeks after trauma</time_frame>
    <description>GAP measures participation by capturing the difference between what the patient wants to perform and actually performs. The measure consists of 30 items and the participant answers yes or no if the person performs the activity, and yes or no if the person wants to perform it.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leisure Time Physical Activity Instrument (LTPI) (Swedish version)</measure>
    <time_frame>Effect size of change from baseline to 16 weeks after trauma</time_frame>
    <description>Captures the participant physical activity level: sedentary, light activity (does not increase respiratory rate), moderate activity (increased respiratory rate and increased body temperature), high activity level (significantly increases respiratory rate and body temperature)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quantity is measured by two questions:</measure>
    <time_frame>Effect size of change from baseline to 16 weeks after trauma</time_frame>
    <description>&quot;Do you think that you get enough sleep?&quot;. Sleep quality is measured by the question: &quot;Considering all, how do you think that you sleep?&quot; The participants answers the questions on a four-grade-scale: the higher number-the better</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RAND-36</measure>
    <time_frame>Effect size of change from baseline to 16 weeks after trauma</time_frame>
    <description>Consists of 36 items that measure health-related quality of life comprising eight subscales ranging from 0-100. The subscales are physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS Swedish version)</measure>
    <time_frame>Effect size of change from baseline to 16 weeks after trauma</time_frame>
    <description>A self-evaluation measure of anxiety and depression in patients in somatic health care. HADS consists of 14 statements (0-21) for each part: HADS-anxiety and HADS-depression. Higher score indicate more server anxiety and depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gender, male and female</measure>
    <time_frame>Relation between gender and change from baseline to 16 weeks after trauma in the outcomes measurements RPQ, MFI, LTPAI,GAP, Sleep, HADS.</time_frame>
    <description>Gender will be collected from the participant medical record at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of head trauma</measure>
    <time_frame>Relation between number of head trauma and change from baseline to 16 weeks after trauma in the outcomes measurements RPQ, MFI, LTPAI,GAP, Sleep, HADS.</time_frame>
    <description>Number of head trauma will be collected from the participants medical record at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trauma caused by another person or not (yes/no)</measure>
    <time_frame>Relation between trauma caused by another person or not and change from baseline to 16 weeks after trauma in the outcomes measurements RPQ, MFI, LTPAI,GAP, Sleep, HADS.</time_frame>
    <description>Information about if trauma is caused by another person or not, will be collected from the participants medical record at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported comorbidity</measure>
    <time_frame>Relation between self-reported comorbidity and change from baseline to 16 weeks after trauma in the outcomes measurements RPQ, MFI, LTPAI,GAP, Sleep, HADS.</time_frame>
    <description>Information about comorbidity will be collected in a structured interview at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Computer Tomografi (CT) assessment</measure>
    <time_frame>Relation between CT assessment and change from baseline to 16 weeks after trauma in the outcomes measurements RPQ, MFI, LTPAI,GAP, Sleep, HADS.</time_frame>
    <description>If Computer Tomografi (CT) assessment was used be collected from the participants medical record at baseline</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <condition>Concussion, Brain</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Early team based neuro-rehabilitation after Traumatic Brain Injury</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Treatment as usual.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Early team based neuro-rehabilitation</intervention_name>
    <description>A structured interview will be made by OT about activity level, and an examination of the patients bodily and neurological symptoms will be made by PT. Based on this result a rehabilitation plan is established consisting of the patient's goals, and the purpose that the patient shall be as active as possible without triggering symptoms. An individual exercise program is prescribed. Between each appointment the patient will have personal tasks to accomplish with the purpose of being active based on symptoms and the adaptation to the current level of energy. The perceived symptoms will be logged. A week-schedule will be created in the purpose of helping the patient to a balanced activity level in relation to their current capacity. The PT assesses physical activity level and reactions to physical strain. Adaptations are made to the exercise program and advice is given on physical activity and exercises. When appropriate OT advices about returning to work and adaptations concerning work.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Head injury for the first time or repeated trauma.&#xD;
&#xD;
          -  Diagnosed with brain concussion (ICD10 S060, S0600) by a physician.&#xD;
&#xD;
          -  Persistent symptoms after mTBI or decreased activity level at time for inclusion.&#xD;
&#xD;
        Exclusions criteria:&#xD;
&#xD;
          -  No remaining symptoms after mTBI at time for inclusion.&#xD;
&#xD;
          -  Returned to previous activity daily living level as before trauma.&#xD;
&#xD;
          -  Other serious illness.&#xD;
&#xD;
          -  Unwillingness to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Narhalsan Sorhaga Rehabmottagning</name>
      <address>
        <city>Alingsas</city>
        <state>Vasta Gotaland</state>
        <zip>44133</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>Lannsjo M, af Geijerstam JL, Johansson U, Bring J, Borg J. Prevalence and structure of symptoms at 3 months after mild traumatic brain injury in a national cohort. Brain Inj. 2009 Mar;23(3):213-9. doi: 10.1080/02699050902748356.</citation>
    <PMID>19205957</PMID>
  </reference>
  <reference>
    <citation>Lundin A, de Boussard C, Edman G, Borg J. Symptoms and disability until 3 months after mild TBI. Brain Inj. 2006 Jul;20(8):799-806. doi: 10.1080/02699050600744327.</citation>
    <PMID>17060147</PMID>
  </reference>
  <reference>
    <citation>Belmont A, Agar N, Azouvi P. Subjective fatigue, mental effort, and attention deficits after severe traumatic brain injury. Neurorehabil Neural Repair. 2009 Nov;23(9):939-44. doi: 10.1177/1545968309340327. Epub 2009 Jul 2.</citation>
    <PMID>19574545</PMID>
  </reference>
  <reference>
    <citation>Ponsford J, Cameron P, Fitzgerald M, Grant M, Mikocka-Walus A. Long-term outcomes after uncomplicated mild traumatic brain injury: a comparison with trauma controls. J Neurotrauma. 2011 Jun;28(6):937-46. doi: 10.1089/neu.2010.1516. Epub 2011 May 25.</citation>
    <PMID>21410321</PMID>
  </reference>
  <reference>
    <citation>Middleboe T, Andersen HS, Birket-Smith M, Friis ML. Minor head injury: impact on general health after 1 year. A prospective follow-up study. Acta Neurol Scand. 1992 Jan;85(1):5-9.</citation>
    <PMID>1546534</PMID>
  </reference>
  <reference>
    <citation>Ziino C, Ponsford J. Selective attention deficits and subjective fatigue following traumatic brain injury. Neuropsychology. 2006 May;20(3):383-90. doi: 10.1037/0894-4105.20.3.383.</citation>
    <PMID>16719631</PMID>
  </reference>
  <reference>
    <citation>Cassidy JD, Cancelliere C, Carroll LJ, Cote P, Hincapie CA, Holm LW, Hartvigsen J, Donovan J, Nygren-de Boussard C, Kristman VL, Borg J. Systematic review of self-reported prognosis in adults after mild traumatic brain injury: results of the International Collaboration on Mild Traumatic Brain Injury Prognosis. Arch Phys Med Rehabil. 2014 Mar;95(3 Suppl):S132-51. doi: 10.1016/j.apmr.2013.08.299.</citation>
    <PMID>24581902</PMID>
  </reference>
  <reference>
    <citation>Lannsjo M, Borg J, Bjorklund G, Af Geijerstam JL, Lundgren-Nilsson A. Internal construct validity of the Rivermead Post-Concussion Symptoms Questionnaire. J Rehabil Med. 2011 Nov;43(11):997-1002. doi: 10.2340/16501977-0875.</citation>
    <PMID>22031345</PMID>
  </reference>
  <reference>
    <citation>Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995 Apr;39(3):315-25. doi: 10.1016/0022-3999(94)00125-o.</citation>
    <PMID>7636775</PMID>
  </reference>
  <reference>
    <citation>Mannerkorpi K, Hernelid C. Leisure Time Physical Activity Instrument and Physical Activity at Home and Work Instrument. Development, face validity, construct validity and test-retest reliability for subjects with fibromyalgia. Disabil Rehabil. 2005 Jun 17;27(12):695-701. doi: 10.1080/09638280400009063.</citation>
    <PMID>16012062</PMID>
  </reference>
  <reference>
    <citation>Akerstedt T, Knutsson A, Westerholm P, Theorell T, Alfredsson L, Kecklund G. Sleep disturbances, work stress and work hours: a cross-sectional study. J Psychosom Res. 2002 Sep;53(3):741-8. doi: 10.1016/s0022-3999(02)00333-1.</citation>
    <PMID>12217447</PMID>
  </reference>
  <reference>
    <citation>Hays RD, Morales LS. The RAND-36 measure of health-related quality of life. Ann Med. 2001 Jul;33(5):350-7. doi: 10.3109/07853890109002089.</citation>
    <PMID>11491194</PMID>
  </reference>
  <reference>
    <citation>Lisspers J, Nygren A, Soderman E. Hospital Anxiety and Depression Scale (HAD): some psychometric data for a Swedish sample. Acta Psychiatr Scand. 1997 Oct;96(4):281-6. doi: 10.1111/j.1600-0447.1997.tb10164.x.</citation>
    <PMID>9350957</PMID>
  </reference>
  <reference>
    <citation>Sawilowsky S. New Effect Size Rules of Thumb. Journal of Modern Applied Statistical Methods [Internet]. 2009 Nov 1;8(2). Available from: http://digitalcommons.wayne.edu/jmasm/vol8/iss2/26 OCH Cohen J. Statistical power analysis for the behavioral sciences. Second edition. Hillsdale: Routlegde; 1988.</citation>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 9, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>December 9, 2018</last_update_submitted>
  <last_update_submitted_qc>December 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Brain Concussion</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03771950
org study id: 470-18
nct id: NCT03771950
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim is to evaluate the study design, procedure and measurements in a randomised
      controlled pilot study.
Despite that mild traumatic brain injury (mTBI) is a common condition managed in various
      healthcare settings, early team based neurorehabilitation (TbNR) in post-concussion syndrom
      (PCS) is sparely investigated. Therefore we aim to design a high quality randomised
      controlled study (RCT) investigating the effect of early TbNR in PCS. Prior this RCT a pilot
      study will be conducted with the aim to evaluate the study design, procedure and
      measurements.

      Method:

      Thirty consecutive patients visiting Alingsås hospital emergency department due to head
      injury caused by fall, trauma to the head, traffic accident or abuse, and diagnosed with
      brain concussion (ICD10 S060, S0600) for the first time or after repeated trauma, will be
      asked to participate in the study. The patient will receive a written study information when
      discharged, and asked if an occupational therapist can contact the patient by phone for
      further information and screening questions 14 days after trauma. If the patient meet the
      inclusion criteria and wish to participate in the study a written informed consent will be
      obtained.

      Test procedure:

      A structured interview and the assessment described below will be performed at baseline 3-4
      weeks after the trauma and after 16 weeks by an occupational therapist. Participant's
      characteristics such as age, gender, work ability, education, social status, previous trauma
      to the head and known comorbidity are collected. The classification of the mTBI will be
      collected from the patients' medical journal, as well as the result and time of the CT
      examination if it has been performed. Information about previous sick leave will be collected
      from the Swedish health insurance office. The number of visits to the occupational therapist
      (OT) and the physiotherapist (PT) will be recorded from the participant's medical journal.

      Study protocol In this pilot study we plan to evaluate broadly as the persons with mTBI may
      suffer from a complex symptomatology, and the causes of persisting symptoms are unclear.

      The following data will be collected:

        -  The number of patients who meet the inclusion criteria.

        -  The number of patients consenting participation in the study.

        -  The number of patients completing questionnaires at baseline and post-test.

        -  The number of patients who participate in the intervention.

      Randomisation:

      After screening for eligibility, fulfilling inclusion criteria and consenting to
      participation the baseline assessment will be conducted by an OT at enrolment. After this the
      patients will be randomised either to the intervention or control group in using lots in
      sealed envelopes based on a computer generated group allocation. The lots are kept in sealed
      envelopes prepared by a person not involved in the study. An OT will open the envelope and
      inform the patient about group allocation. All care providers will be blinded for baseline
      and post-test outcomes. A research co-worker who are involved in data management will be
      blinded for group allocation.

      Interventions:

      The patients randomised to the intervention group (n=15) will be treated by the PT and OT in
      TbNR. At the first visits a medical history will be taken, there after a structured interview
      will be made by the OT about activity level, and an examination of the patients bodily and
      neurological symptoms will be made by the PT. Based on this result a TbNR a rehabilitation
      plan is established consisting of the patient's goals, and the purpose that the patient shall
      be as active as possible without triggering symptoms. An individual exercise program is
      prescribed. Number of visits to TbNR will depend on the individual need for rehabilitation.

      Between each appointment with TbNR, the patient will have personal tasks to accomplish with
      the purpose of being active based on symptoms and the adaptation to the current level of
      energy. Information about underlying causes of perceived symptoms will be present at the
      visits, and the patient will be given help to analyze the tasks that has been performed
      during the past week. The perceived symptoms will be logged in an activity log including
      estimation of fatigue and headache. A week-schedule will be created in the purpose of helping
      the patient to a balanced activity level in relation to their current capacity.

      The PT assesses physical activity level and reactions to physical strain. Adaptations are
      made to the exercise program and advice is given on physical activity and exercises. When
      appropriate the OT advices about returning to work and adaptations concerning work.

      Control:

      Participants will be treated as usual, which is that they can search health care by themself.

      Statistics:

      Ratio and interval data are presented as mean ± 1 standard deviation (SD), ordinal data are
      presented as median, and 25th and 75th percentile, nominal data are presented in absolute and
      relative numbers.

      Change between baseline and post-test will be analyzed for each outcome measure and between
      the groups. Depending if the data are normal distributed or not parametric or non-parametric
      tests will be used for differences between group.

      Effect sizes and 95% confidence intervals will be calculated. Cohen's d will be used to
      estimate the effect size using mean difference between groups and pooled standard deviation
      of the mean differences. The magnitude of effect size will be considered small for d = 0.2 -
      0.49, medium for d = 0.5-0.79, and large for d = 0.8-1.1 (16).

      Odds ratio will be used to estimate effect size for binary dependent variable using logistic
      regression. Linear regression analysis will be used for change of outcome measurements
      adjusting for gender, number of head trauma and if the injury has been caused by another
      person or not. The Statistical Package for Social Science (SPSS) for Windows, Version 22.0,
      2013. IBM Corp, Armonk, NY: USA will be used for statistical analyses. A p-value < 0.05 is
      considered statistical significant.

      Sample size:

      In the planned pilot study 30 participants will be enrolled. This sample size is considered
      to be sufficient to analyze effect size for the included outcome measurements which will be
      used for planning the full-scale randomized controlled study involving more emergency
      hospitals and neuro teams.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: After screening for eligibility, fulfilling inclusion criteria and consenting to participation the baseline assessment will be conducted by an OT at enrolment. After this the patients will be randomised either to the intervention or control group in using lots in sealed envelopes based on a computer generated group allocation. The lots are kept in sealed envelopes prepared by a person not involved in the study. An OT will open the envelope and inform the patient about group allocation. All care providers will be blinded for baseline and post-test outcomes. A research co-worker who are involved in data management will be blinded for group allocation.
measure: Numbers of patients who meet the inclusion criteria and accept participation in the study?
time frame: 16 weeks after trauma
description: Count how many of the patients want to participate in the study
measure: Numbers of participants who respond to the included measurements?
time frame: 16 weeks after trauma
description: Count the number
measure: Numbers of participants who complete post-test?
time frame: 16 weeks after trauma
description: Count the number
measure: Rivermead post-concussion symtoms questionnaire (Swedish version) (RPQ)
time frame: Effect size of change from baseline to 16 weeks after trauma
description: A valid, reliable and established measurement of self-perceived symptoms after brain concussion. The measurement consists of 16 items concerning perceived headache, vertigo, nausea, sensitivity to sound, sleeping disorders, fatigue, irritability, depression, frustration, poor memory, poor concentration, longer time to think, blurred vision, sensitivity to light, double vision and restlessness the past 24 hours compared to before the head injury. The symptoms are assessed on a 5-pointscale: never had symptom (category 0), had symptoms but they resolved (category 1), had moderate problems with symptom (category 2), having moderate problems with symptom (category 3), having severe problem with symptom (category 4)
measure: Multidimensional Fatigue Inventory (MFI)
time frame: Effect size of change from baseline to 16 weeks after trauma
description: A valid and reliable measurement consisting of 20 items to measure fatigue. Various dimensions are estimated such as general fatigue, physical fatigue, decreased activity, reduced motivation and mental fatigue.
measure: Activity level is measured with GAP in everyday activity.
time frame: Effect size of change from baseline to 16 weeks after trauma
description: GAP measures participation by capturing the difference between what the patient wants to perform and actually performs. The measure consists of 30 items and the participant answers yes or no if the person performs the activity, and yes or no if the person wants to perform it.
measure: Leisure Time Physical Activity Instrument (LTPI) (Swedish version)
time frame: Effect size of change from baseline to 16 weeks after trauma
description: Captures the participant physical activity level: sedentary, light activity (does not increase respiratory rate), moderate activity (increased respiratory rate and increased body temperature), high activity level (significantly increases respiratory rate and body temperature)
measure: Sleep quantity is measured by two questions:
time frame: Effect size of change from baseline to 16 weeks after trauma
description: "Do you think that you get enough sleep?". Sleep quality is measured by the question: "Considering all, how do you think that you sleep?" The participants answers the questions on a four-grade-scale: the higher number-the better
measure: RAND-36
time frame: Effect size of change from baseline to 16 weeks after trauma
description: Consists of 36 items that measure health-related quality of life comprising eight subscales ranging from 0-100. The subscales are physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health
measure: Hospital Anxiety and Depression Scale (HADS Swedish version)
time frame: Effect size of change from baseline to 16 weeks after trauma
description: A self-evaluation measure of anxiety and depression in patients in somatic health care. HADS consists of 14 statements (0-21) for each part: HADS-anxiety and HADS-depression. Higher score indicate more server anxiety and depression.
measure: Gender, male and female
time frame: Relation between gender and change from baseline to 16 weeks after trauma in the outcomes measurements RPQ, MFI, LTPAI,GAP, Sleep, HADS.
description: Gender will be collected from the participant medical record at baseline
measure: Number of head trauma
time frame: Relation between number of head trauma and change from baseline to 16 weeks after trauma in the outcomes measurements RPQ, MFI, LTPAI,GAP, Sleep, HADS.
description: Number of head trauma will be collected from the participants medical record at baseline
measure: Trauma caused by another person or not (yes/no)
time frame: Relation between trauma caused by another person or not and change from baseline to 16 weeks after trauma in the outcomes measurements RPQ, MFI, LTPAI,GAP, Sleep, HADS.
description: Information about if trauma is caused by another person or not, will be collected from the participants medical record at baseline
measure: Self-reported comorbidity
time frame: Relation between self-reported comorbidity and change from baseline to 16 weeks after trauma in the outcomes measurements RPQ, MFI, LTPAI,GAP, Sleep, HADS.
description: Information about comorbidity will be collected in a structured interview at baseline
measure: Computer Tomografi (CT) assessment
time frame: Relation between CT assessment and change from baseline to 16 weeks after trauma in the outcomes measurements RPQ, MFI, LTPAI,GAP, Sleep, HADS.
description: If Computer Tomografi (CT) assessment was used be collected from the participants medical record at baseline
arm group label: Intervention group
arm group type: Experimental
description: Early team based neuro-rehabilitation after Traumatic Brain Injury
arm group label: Control group
arm group type: No Intervention
description: Treatment as usual.
intervention type: Behavioral
intervention name: Early team based neuro-rehabilitation
description: A structured interview will be made by OT about activity level, and an examination of the patients bodily and neurological symptoms will be made by PT. Based on this result a rehabilitation plan is established consisting of the patient's goals, and the purpose that the patient shall be as active as possible without triggering symptoms. An individual exercise program is prescribed. Between each appointment the patient will have personal tasks to accomplish with the purpose of being active based on symptoms and the adaptation to the current level of energy. The perceived symptoms will be logged. A week-schedule will be created in the purpose of helping the patient to a balanced activity level in relation to their current capacity. The PT assesses physical activity level and reactions to physical strain. Adaptations are made to the exercise program and advice is given on physical activity and exercises. When appropriate OT advices about returning to work and adaptations concerning work.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Sweden
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responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Brain Concussion
mesh term: Wounds and Injuries