Brain-behavior Associations of Sensorimotor Therapy Post Stroke

NCT03236376 | Completed

• 1 other identifier: s60278
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

upper limb; somatosensory impairments; motor impairments; brain imaging

Outcome Measures

Primary Outcomes (1)

• Action Research Arm Test

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

  within 4 months post stroke

Secondary Outcomes (7)

• Fugl-Meyer motor Assessment-upper Extremity

  within 4 months post stroke

• composite standardized somatosensory deficit index

  within 4 months post stroke

• Erasmus modified Nottingham Sensory Assessment

  within 4 months post stroke

• Perceptual Threshold of Touch

  within 4 months post stroke

• Nine Hole Peg test

  within 4 months post stroke

Study Arms (2)

sensorimotor therapy

EXPERIMENTAL

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

motor therapy

ACTIVE COMPARATOR

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

Interventions

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.

sensorimotor therapy

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

motor therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Research Foundation Flanders: collaborator
• KU Leuven: collaborator

Study Sites (1)

KU Leuven

Leuven, Belgium

Location

Related Publications (3)

• 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.

  PMID: 21350049 RESULT

• 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.

  PMID: 33343498 DERIVED

• 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.

  PMID: 29678195 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Geert Verheyden

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor will be masked for treatment group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: August 1, 2017
• Study Start: September 21, 2017
• Primary Completion: December 1, 2017
• Study Completion: January 6, 2020
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

BE (1)