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

NCT03771950 | Unknown

• 1 other identifier: 470-18
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Traumatic Brain Injury; Concussion, Brain

Keywords

rehabilitation

Outcome Measures

Primary Outcomes (1)

• Numbers of patients who meet the inclusion criteria and accept participation in the study?

  Count how many of the patients want to participate in the study

  16 weeks after trauma

Secondary Outcomes (14)

• Numbers of participants who respond to the included measurements?

  16 weeks after trauma

• Numbers of participants who complete post-test?

  16 weeks after trauma

• Rivermead post-concussion symtoms questionnaire (Swedish version) (RPQ)

  Effect size of change from baseline to 16 weeks after trauma

• Multidimensional Fatigue Inventory (MFI)

  Effect size of change from baseline to 16 weeks after trauma

• Activity level is measured with GAP in everyday activity.

  Effect size of change from baseline to 16 weeks after trauma

Study Arms (2)

Intervention group

EXPERIMENTAL

Early team based neuro-rehabilitation after Traumatic Brain Injury

Behavioral: Early team based neuro-rehabilitation

Control group

NO INTERVENTION

Treatment as usual.

Interventions

Early team based neuro-rehabilitation BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Head injury for the first time or repeated trauma.
• Diagnosed with brain concussion (ICD10 S060, S0600) by a physician.
• Returned to previous activity daily living level as before trauma.
• Other serious illness.
• Unwillingness to participate in the study.

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Alingsas hospital emergincy section: collaborator
• Narhalsan primary care rehabilitation: collaborator

Study Sites (1)

Narhalsan Sorhaga Rehabmottagning

Alingsås, Vasta Gotaland, 44133, Sweden

Location

Related Publications (14)

• 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.

  PMID: 19205957 BACKGROUND

• 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.

  PMID: 17060147 BACKGROUND

• 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.

  PMID: 19574545 BACKGROUND

• 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.

  PMID: 21410321 BACKGROUND

• 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.

  PMID: 1546534 BACKGROUND

• 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.

  PMID: 16719631 BACKGROUND

• 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.

  PMID: 24581902 BACKGROUND

• 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.

  PMID: 22031345 BACKGROUND

• 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.

  PMID: 7636775 BACKGROUND

• 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.

  PMID: 16012062 BACKGROUND

• 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.

  PMID: 12217447 BACKGROUND

• 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.

  PMID: 11491194 BACKGROUND

• 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.

  PMID: 9350957 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: December 11, 2018
• Study Start: January 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: December 11, 2018

Record last verified: 2018-12

Locations

SE (1)