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Brain-behavior Associations of Sensorimotor Therapy Post Stroke

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03236376
Enrollment
59
Registered
2017-08-01
Start date
2017-09-21
Completion date
2020-01-06
Last updated
2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

upper limb, somatosensory impairments, motor impairments, brain imaging

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.

Interventions

OTHERadditional 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.

OTHERadditional 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

Sponsors

Research Foundation Flanders
CollaboratorOTHER
KU Leuven
CollaboratorOTHER
Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The assessor will be masked for treatment group

Intervention model description

Randomized controlled Trial with two therapy groups ( experimental and control therapy) and one healthy control group

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Action Research Arm Testwithin 4 months post strokegrasp, grip, pinch and gross movement of the affected arm and hand

Secondary

MeasureTime frameDescription
composite standardized somatosensory deficit indexwithin 4 months post strokecomposite standardized score consisting of fabric matching test, wrist position sense test and functional tactile object recognition test
Erasmus modified Nottingham Sensory Assessmentwithin 4 months post strokelight touch, pressure, sharp, sharp-dull discrimination, position sense of the arm and hand
Perceptual Threshold of Touchwithin 4 months post strokethreshold of light touch determined with Transcutaneous Electric Nerve Stimulation at the index finger.
Fugl-Meyer motor Assessment-upper Extremitywithin 4 months post strokeoverall motor impairment of the affected upper limb: shoulder, arm, wrist , hand and fingers
Stroke Upper Limb Capacity Scalewithin 4 months post strokeupper limb capacity by the means of ten functional and meaningful tasks related to daily live activities
functional connectivitywithin 4 months post strokeresting-state fMRI functional connectivity between Regions of Interest of the sensorimotor network
Nine Hole Peg testwithin 4 months post strokemanual dexterity

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026