KU Leuven
Leuven, Belgium
NCT Number: NCT03236376
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Leuven, Belgium
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, will conduct a Randomized Controlled Trial with three main objectives.
The first objective of this project is to investigate the effect of sensorimotor therapy on motor function of the upper limb. To achieve this objective, a sensorimotor program will be developed based on the SENSE therapy. Patients will be randomly allocated to either the sensorimotor therapy group or the pure motor therapy group; and will receive 16 hours of therapy. Motor and Somatosensory assessments will be performed at three time points: baseline(admission to rehabilitation center), immediately after the 16 hours of therapy and after 4 weeks of follow-up.
The second objective is to investigate therapy-induced brain-behavior associations with resting state functional connectivity. In order to achieve insights in brain-behavior associations, we will perform resting-state functional Magnetic Resonance Imaging (fMRI) scans at the same time points as the clinical assessments: baseline, immediately after the 16 hours of therapy, and four weeks after the end of the therapy. Both measurements, brain-imaging and clinical measurements will be combined to investigate the associations.
This project will lead to new insights in brain-behavior associations of sensorimotor function of the upper limb after stroke and will provide evidence for a new therapy in upper limb stroke rehabilitation.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention will consist of additional physiotherapy for the upper limb after stroke consisting of sensory discrimination training and sensorimotor training.
The intervention will consist of additional physiotherapy for the upper limb after stroke consisting of cognitive-attention based training and motor training
Time frame: within 4 months post stroke
grasp, grip, pinch and gross movement of the affected arm and hand
Time frame: within 4 months post stroke
overall motor impairment of the affected upper limb: shoulder, arm, wrist , hand and fingers
Time frame: within 4 months post stroke
composite standardized score consisting of fabric matching test, wrist position sense test and functional tactile object recognition test
Time frame: within 4 months post stroke
light touch, pressure, sharp, sharp-dull discrimination, position sense of the arm and hand
Time frame: within 4 months post stroke
threshold of light touch determined with Transcutaneous Electric Nerve Stimulation at the index finger.
Time frame: within 4 months post stroke
manual dexterity
Time frame: within 4 months post stroke
upper limb capacity by the means of ten functional and meaningful tasks related to daily live activities
Time frame: within 4 months post stroke
resting-state fMRI functional connectivity between Regions of Interest of the sensorimotor network
Universitaire Ziekenhuizen KU Leuven
Other
Behavioral and Brain Connectivity Analysis of Upper Limb Sensorimotor Rehabilitation Post Stroke: a Randomized Controlled Trial
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