Stroke Clinical Trial
Official title:
Behavioral and Brain Connectivity Analysis of Upper Limb Sensorimotor Rehabilitation Post Stroke: a Randomized Controlled Trial
Verified date | January 2020 |
Source | Universitaire Ziekenhuizen Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Stroke survivors often encounter impairments in the upper limb after stroke. Sensorimotor impairments are present in 67% of the stroke patients, resulting in problems with independency and performance of activities of daily life. In addition, the pattern of recovery in the brain is still a matter of ongoing debate. Although the importance of somatosensory function on motor performance is well described, evidence for somatosensory or sensorimotor therapy and brain-related changes is scares. Therefore, we aim to explore the effect of a sensorimotor therapy compared to pure motor therapy on motor function of the upper limb. A second objective is to investigate therapy-induced brain-behavior associations using resting state functional Magnetic Resonance Imaging of the brain.
Status | Completed |
Enrollment | 59 |
Est. completion date | January 6, 2020 |
Est. primary completion date | December 1, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - first ever stroke as defined by the WHO (world health organisation) criteria - assessed and included within 8 weeks after stroke onset - unilateral motor impairment in the upper limb (ARAT <52/56) - unilateral somatosensory impairment in the upper limb (SSD <0.00) - minimally 18 years old - substantially cooperation to perform the assessments and therapy - written informed consent Exclusion Criteria: - musculoskeletal and/or other neurological disorders such as previous stroke, head injuries, multiple sclerosis of Parkinson's disease - a subdural hematoma, tumor, encephalitis or trauma that lead to similar symptoms as a stroke - severe communication deficits - severe cognitive deficits - the presence of contra-indications for proceeding an MRI scan such as defibrillator, pacemaker or metal prosthesis ( as defined in the MRI checklist of Radiology UZ Leuven) |
Country | Name | City | State |
---|---|---|---|
Belgium | KU Leuven | Leuven |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen Leuven | KU Leuven, Research Foundation Flanders |
Belgium,
Carey L, Macdonell R, Matyas TA. SENSe: Study of the Effectiveness of Neurorehabilitation on Sensation: a randomized controlled trial. Neurorehabil Neural Repair. 2011 May;25(4):304-13. doi: 10.1177/1545968310397705. Epub 2011 Feb 24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Action Research Arm Test | grasp, grip, pinch and gross movement of the affected arm and hand | within 4 months post stroke | |
Secondary | Fugl-Meyer motor Assessment-upper Extremity | overall motor impairment of the affected upper limb: shoulder, arm, wrist , hand and fingers | within 4 months post stroke | |
Secondary | composite standardized somatosensory deficit index | composite standardized score consisting of fabric matching test, wrist position sense test and functional tactile object recognition test | within 4 months post stroke | |
Secondary | Erasmus modified Nottingham Sensory Assessment | light touch, pressure, sharp, sharp-dull discrimination, position sense of the arm and hand | within 4 months post stroke | |
Secondary | Perceptual Threshold of Touch | threshold of light touch determined with Transcutaneous Electric Nerve Stimulation at the index finger. | within 4 months post stroke | |
Secondary | Nine Hole Peg test | manual dexterity | within 4 months post stroke | |
Secondary | Stroke Upper Limb Capacity Scale | upper limb capacity by the means of ten functional and meaningful tasks related to daily live activities | within 4 months post stroke | |
Secondary | functional connectivity | resting-state fMRI functional connectivity between Regions of Interest of the sensorimotor network | within 4 months post stroke |
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