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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03236376
Other study ID # s60278
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 21, 2017
Est. completion date January 6, 2020

Study information

Verified date January 2020
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
additional sensorimotor therapy for the upper limb
The intervention will consist of additional physiotherapy for the upper limb after stroke consisting of sensory discrimination training and sensorimotor training.
additional motor therapy for the upper limb after stroke
The intervention will consist of additional physiotherapy for the upper limb after stroke consisting of cognitive-attention based training and motor training

Locations

Country Name City State
Belgium KU Leuven Leuven

Sponsors (3)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven KU Leuven, Research Foundation Flanders

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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

Outcome

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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