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Early Team Based Neuro-rehabilitation After Traumatic Brain Injury - a Pilot Study

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ClinicalTrials.gov Identifier: NCT03771950
Recruitment Status : Not yet recruiting
First Posted : December 11, 2018
Last Update Posted : December 11, 2018
Sponsor:
Collaborators:
Alingsas hospital emergincy section
Narhalsan primary care rehabilitation
Narhalsan Reasearch and Development primary care Region Vastra Gotaland
Information provided by (Responsible Party):
Vastra Gotaland Region

Brief Summary:
The aim is to evaluate the study design, procedure and measurements in a randomised controlled pilot study.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Concussion, Brain Behavioral: Early team based neuro-rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Primary Purpose: Treatment
Official Title: Early Team Based Neuro-rehabilitation After Traumatic Brain Injury - a Pilot Study
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
Early team based neuro-rehabilitation after Traumatic Brain Injury
Behavioral: Early team based neuro-rehabilitation
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.

No Intervention: Control group
Treatment as usual.



Primary Outcome Measures :
  1. Numbers of patients who meet the inclusion criteria and accept participation in the study? [ Time Frame: 16 weeks after trauma ]
    Count how many of the patients want to participate in the study


Secondary Outcome Measures :
  1. Numbers of participants who respond to the included measurements? [ Time Frame: 16 weeks after trauma ]
    Count the number

  2. Numbers of participants who complete post-test? [ Time Frame: 16 weeks after trauma ]
    Count the number

  3. Rivermead post-concussion symtoms questionnaire (Swedish version) (RPQ) [ Time Frame: Effect size of change from baseline to 16 weeks after trauma ]
    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)

  4. Multidimensional Fatigue Inventory (MFI) [ Time Frame: Effect size of change from baseline to 16 weeks after trauma ]
    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.

  5. Activity level is measured with GAP in everyday activity. [ Time Frame: Effect size of change from baseline to 16 weeks after trauma ]
    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.

  6. Leisure Time Physical Activity Instrument (LTPI) (Swedish version) [ Time Frame: Effect size of change from baseline to 16 weeks after trauma ]
    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)

  7. Sleep quantity is measured by two questions: [ Time Frame: Effect size of change from baseline to 16 weeks after trauma ]
    "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

  8. RAND-36 [ Time Frame: Effect size of change from baseline to 16 weeks after trauma ]
    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

  9. Hospital Anxiety and Depression Scale (HADS Swedish version) [ Time Frame: Effect size of change from baseline to 16 weeks after trauma ]
    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.

  10. 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. ]
    Gender will be collected from the participant medical record at baseline

  11. 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. ]
    Number of head trauma will be collected from the participants medical record at baseline

  12. 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. ]
    Information about if trauma is caused by another person or not, will be collected from the participants medical record at baseline

  13. 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. ]
    Information about comorbidity will be collected in a structured interview at baseline

  14. 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. ]
    If Computer Tomografi (CT) assessment was used be collected from the participants medical record at baseline



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Head injury for the first time or repeated trauma.
  • Diagnosed with brain concussion (ICD10 S060, S0600) by a physician.
  • Persistent symptoms after mTBI or decreased activity level at time for inclusion.

Exclusions criteria:

  • No remaining symptoms after mTBI at time for inclusion.
  • Returned to previous activity daily living level as before trauma.
  • Other serious illness.
  • Unwillingness to participate in 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): NCT03771950


Locations
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Sweden
Narhalsan Sorhaga Rehabmottagning Not yet recruiting
Alingsas, Vasta Gotaland, Sweden, 44133
Sponsors and Collaborators
Vastra Gotaland Region
Alingsas hospital emergincy section
Narhalsan primary care rehabilitation
Narhalsan Reasearch and Development primary care Region Vastra Gotaland

Publications:
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.

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Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT03771950     History of Changes
Other Study ID Numbers: 470-18
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

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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 Vastra Gotaland Region:
rehabilitation

Additional relevant MeSH terms:
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Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases