Brain-behavior Associations of Sensorimotor Therapy Post Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: additional motor therapy for the upper limb after stroke; Other: additional sensorimotor therapy for the upper limb

• Registration Number: NCT03236376
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-07-31
• Study First Posted: 2017-08-01
• Study Start: 2017-09-21
• Primary Completion: 2017-12-01
• Status Verified: 2020-01
• Study Completion: 2020-01-06
• Last Update Submitted: 2020-01-16
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
motor therapy	additional motor therapy for the upper limb after stroke	The motor therapy consists of 30 minutes of cognitive and attention-based table top games and 30 minutes of motor training per session. The cognitive-attention-based therapy consists of table top games such as chess, rush hour, or other smart games. Individually tailored motor therapy consists of a unilateral motor exercise program for the upper limb, while seated at a table, under supervision of a therapist to match the therapy and intensity provided in the other sensorimotor therapy group. This 30 minutes of motor arm training is based on a set of standardized exercises which comprise task-related practice for gross movements and dexterity including different grips and selective finger movements, and training in daily life activities, however without any attention to sensory discrimination training.
sensorimotor therapy	additional sensorimotor therapy for the upper limb	sensorimotor therapy will consist of 30minutes of sensory discrimination training and 30 minutes of sensorimotor training per session. The sensory discrimination training is based on on the SENSe training of Carey et all. The sensorimotor training is the same individually tailored motor therapy as described below, but with integration of sensory discrimination training aspects.

Primary Outcome Measures

Name	Time	Method
Action Research Arm Test	within 4 months post stroke	grasp, grip, pinch and gross movement of the affected arm and hand

Secondary Outcome Measures

Name	Time	Method
Fugl-Meyer motor Assessment-upper Extremity	within 4 months post stroke	overall motor impairment of the affected upper limb: shoulder, arm, wrist , hand and fingers
composite standardized somatosensory deficit index	within 4 months post stroke	composite standardized score consisting of fabric matching test, wrist position sense test and functional tactile object recognition test
Erasmus modified Nottingham Sensory Assessment	within 4 months post stroke	light touch, pressure, sharp, sharp-dull discrimination, position sense of the arm and hand
Perceptual Threshold of Touch	within 4 months post stroke	threshold of light touch determined with Transcutaneous Electric Nerve Stimulation at the index finger.
Nine Hole Peg test	within 4 months post stroke	manual dexterity
Stroke Upper Limb Capacity Scale	within 4 months post stroke	upper limb capacity by the means of ten functional and meaningful tasks related to daily live activities
functional connectivity	within 4 months post stroke	resting-state fMRI functional connectivity between Regions of Interest of the sensorimotor network

Trial Locations

Locations (1)

KU Leuven; 🇧🇪 Leuven, Belgium