Brain-behavior Associations of Sensorimotor Therapy Post Stroke

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: additional sensorimotor therapy for the upper limb; Other: additional motor therapy for the upper limb after stroke

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 Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • KU Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sensorimotor therapy; 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.	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.
Active Comparator: motor therapy; 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.	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Action Research Arm Test	grasp, grip, pinch and gross movement of the affected arm and hand	within 4 months post stroke

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Erasmus modified Nottingham Sensory Assessment	light touch, pressure, sharp, sharp-dull discrimination, position sense of the arm and hand	within 4 months post stroke
Perceptual Threshold of Touch	threshold of light touch determined with Transcutaneous Electric Nerve Stimulation at the index finger.	within 4 months post stroke
Nine Hole Peg test	manual dexterity	within 4 months post stroke
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
functional connectivity	resting-state fMRI functional connectivity between Regions of Interest of the sensorimotor network	within 4 months post stroke

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: KU Leuven; Research Foundation Flanders
• Investigators: Principal Investigator: Geert Verheyden, KU Leuven

Publications and helpful links

General Publications

• 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.
• De Bruyn N, Saenen L, Thijs L, Van Gils A, Ceulemans E, Essers B, Lafosse C, Michielsen M, Beyens H, Schillebeeckx F, Alaerts K, Verheyden G. Sensorimotor vs. Motor Upper Limb Therapy for Patients With Motor and Somatosensory Deficits: A Randomized Controlled Trial in the Early Rehabilitation Phase After Stroke. Front Neurol. 2020 Dec 4;11:597666. doi: 10.3389/fneur.2020.597666. eCollection 2020.
• De Bruyn N, Essers B, Thijs L, Van Gils A, Tedesco Triccas L, Meyer S, Alaerts K, Verheyden G. Does sensorimotor upper limb therapy post stroke alter behavior and brain connectivity differently compared to motor therapy? Protocol of a phase II randomized controlled trial. Trials. 2018 Apr 20;19(1):242. doi: 10.1186/s13063-018-2609-4.

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2017
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): January 6, 2020

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: July 31, 2017
• First Posted (Actual): August 1, 2017

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 16, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: upper limb; brain imaging; somatosensory impairments; motor impairments
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: s60278

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No