Brain-behavior Associations of Sensorimotor Therapy Post Stroke

NCT ID: NCT03236376

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-21
• Study Completion Date: 2020-01-06

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

additional sensorimotor therapy for the upper limb

Intervention Type: OTHER

The intervention will consist of additional physiotherapy for the upper limb after stroke consisting of sensory discrimination training and sensorimotor training.

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.

Group Type: ACTIVE_COMPARATOR

additional motor therapy for the upper limb after stroke

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Research Foundation Flanders

OTHER

Sponsor Role: collaborator

KU Leuven

OTHER

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Geert Verheyden

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Geert Verheyden

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

KU Leuven

Leuven, , Belgium

Countries

Belgium

References

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.

Reference Type: RESULT

PMID: 21350049 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33343498 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29678195 (View on PubMed)

Other Identifiers

s60278

Identifier Type: -

Identifier Source: org_study_id