Skip to main content
OpenTrials
Completed

NCT Number: NCT03236376

Brain-behavior Associations of Sensorimotor Therapy Post Stroke

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KU Leuven

Leuven, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

additional sensorimotor therapy for the upper limb

Other

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

Other

The intervention will consist of additional physiotherapy for the upper limb after stroke consisting of cognitive-attention based training and motor training

Primary outcomes

  1. Action Research Arm Test

    Time frame: within 4 months post stroke

    grasp, grip, pinch and gross movement of the affected arm and hand

Secondary outcomes

  1. Fugl-Meyer motor Assessment-upper Extremity

    Time frame: within 4 months post stroke

    overall motor impairment of the affected upper limb: shoulder, arm, wrist , hand and fingers

  2. composite standardized somatosensory deficit index

    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

  3. Erasmus modified Nottingham Sensory Assessment

    Time frame: within 4 months post stroke

    light touch, pressure, sharp, sharp-dull discrimination, position sense of the arm and hand

  4. Perceptual Threshold of Touch

    Time frame: within 4 months post stroke

    threshold of light touch determined with Transcutaneous Electric Nerve Stimulation at the index finger.

  5. Nine Hole Peg test

    Time frame: within 4 months post stroke

    manual dexterity

  6. Stroke Upper Limb Capacity Scale

    Time frame: within 4 months post stroke

    upper limb capacity by the means of ten functional and meaningful tasks related to daily live activities

  7. functional connectivity

    Time frame: within 4 months post stroke

    resting-state fMRI functional connectivity between Regions of Interest of the sensorimotor network

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • KU Leuven
  • Research Foundation Flanders

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2020
First posted
Aug 1, 2017
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.