Will patients with severe acquired brain injury develop abnormal joint positions and reduced mobility during hospitalisation at a neurorehabilitation department?
Not Applicable
Completed
- Conditions
- Severe aquired brain injuryInjury, Occupational Diseases, Poisoning
- Registration Number
- ISRCTN17910097
- Lead Sponsor
- Rigshospitalet
- Brief Summary
2019 results in https://pubmed.ncbi.nlm.nih.gov/31347406/ (added 25/11/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
Patients who must meet all of the following inclusion criteria:
1. >18 years
2. Patients with severe aquired brain injury who are admitted to rehabilitation at Department of Neurorehabilitation.
3. Patients with palsy or paralysis in at least one of the lower extremities.
Healthy controls:
1. Healthy adults >18 years
Exclusion Criteria
Patients:
1. Patients with fractures of the lower extremities
2. Patients with non-cooperative behavior
Controls:
1. Musculoskeletal disorders.
2. Diabetes Mellitus Type 2.
3. Use of muscle relaxation drugs or neuromuscular blocking agents.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Passive ankle joint stiffness during both slow and fast dorsiflexions is measured using a biomechanical, hand-held device. Patients with severe acquired brain injuries are measured once every week during hospitalization. One year after their injury date, patients will attend one test session. Healthy controls are measured once.<br> 2. Quantification of the occurrence of muscle contractures from measurements of range of motion is measured using a hand-held device containing a gyroscope”. Measurements are taken once every week during hospitalization and 1 year after the injury. Healthy controls are measured once during one test session.<br> 3. Quantification of the occurrence of spasticity during hospitalization and one year after the injury is measured using the hand-held device and is compared to the clinical measure of spasticity using the MAS test<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Changes in collagen types, actin and myosin involved in construction of muscle tissue are” measured from a blood sample taken from the patients at the first test session during hospitalization and in the beginning of the test session for the healthy controls. Blood samples are analyzed with the Next Generation Sequencing method.<br> 2. Clinical data is measured during hospitalization:<br> 2.1. Functional independence measure (FIM™)<br> 2.2. Early Functional Abilities (EFA)<br> 2.3. Glasgow Come Scale (GCS)<br> 2.4. Glasgow Outcome Scale-Extended (GOS-E)<br> 3. The amount of physiotherapy and any use spasticity reducing medication are registered in a database by the clinicians with information on date, type and amount of treatment. Information relevant to the study will then be extracted from the database.<br>