Brain-behavior Associations of Sensorimotor Therapy Post Stroke

Stroke Clinical Trial

Official title:

Behavioral and Brain Connectivity Analysis of Upper Limb Sensorimotor Rehabilitation Post Stroke: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03236376
• Other study ID #: s60278
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Stroke

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