Early Team Based Neuro-rehabilitation After Traumatic Brain Injury - a Pilot Study
NCT ID: NCT03771950
Last Updated: 2018-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
30 participants
INTERVENTIONAL
2019-01-01
2021-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention group
Early team based neuro-rehabilitation after Traumatic Brain Injury
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.
Control group
Treatment as usual.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Alingsas hospital emergincy section
UNKNOWN
Narhalsan primary care rehabilitation
UNKNOWN
Vastra Gotaland Region
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Narhalsan Sorhaga Rehabmottagning
Alingsås, Vasta Gotaland, Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
470-18
Identifier Type: -
Identifier Source: org_study_id