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Brain-behavior Associations of Sensorimotor Therapy Post Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
additional sensorimotor therapy for the upper limb
additional motor therapy for the upper limb after stroke
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring upper limb, somatosensory impairments, motor impairments, brain imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • KU Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

sensorimotor therapy

motor therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Action Research Arm Test
grasp, grip, pinch and gross movement of the affected arm and hand

Secondary Outcome Measures

Fugl-Meyer motor Assessment-upper Extremity
overall motor impairment of the affected upper limb: shoulder, arm, wrist , hand and fingers
composite standardized somatosensory deficit index
composite standardized score consisting of fabric matching test, wrist position sense test and functional tactile object recognition test
Erasmus modified Nottingham Sensory Assessment
light touch, pressure, sharp, sharp-dull discrimination, position sense of the arm and hand
Perceptual Threshold of Touch
threshold of light touch determined with Transcutaneous Electric Nerve Stimulation at the index finger.
Nine Hole Peg test
manual dexterity
Stroke Upper Limb Capacity Scale
upper limb capacity by the means of ten functional and meaningful tasks related to daily live activities
functional connectivity
resting-state fMRI functional connectivity between Regions of Interest of the sensorimotor network

Full Information

First Posted
June 20, 2017
Last Updated
January 16, 2020
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Research Foundation Flanders, KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT03236376
Brief Title
Brain-behavior Associations of Sensorimotor Therapy Post Stroke
Official Title
Behavioral and Brain Connectivity Analysis of Upper Limb Sensorimotor Rehabilitation Post Stroke: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 21, 2017 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
January 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Research Foundation Flanders, KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
upper limb, somatosensory impairments, motor impairments, brain imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled Trial with two therapy groups ( experimental and control therapy) and one healthy control group
Masking
Outcomes Assessor
Masking Description
The assessor will be masked for treatment group
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sensorimotor therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
motor therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
additional sensorimotor therapy for the upper limb
Intervention Description
The intervention will consist of additional physiotherapy for the upper limb after stroke consisting of sensory discrimination training and sensorimotor training.
Intervention Type
Other
Intervention Name(s)
additional motor therapy for the upper limb after stroke
Intervention Description
The intervention will consist of additional physiotherapy for the upper limb after stroke consisting of cognitive-attention based training and motor training
Primary Outcome Measure Information:
Title
Action Research Arm Test
Description
grasp, grip, pinch and gross movement of the affected arm and hand
Time Frame
within 4 months post stroke
Secondary Outcome Measure Information:
Title
Fugl-Meyer motor Assessment-upper Extremity
Description
overall motor impairment of the affected upper limb: shoulder, arm, wrist , hand and fingers
Time Frame
within 4 months post stroke
Title
composite standardized somatosensory deficit index
Description
composite standardized score consisting of fabric matching test, wrist position sense test and functional tactile object recognition test
Time Frame
within 4 months post stroke
Title
Erasmus modified Nottingham Sensory Assessment
Description
light touch, pressure, sharp, sharp-dull discrimination, position sense of the arm and hand
Time Frame
within 4 months post stroke
Title
Perceptual Threshold of Touch
Description
threshold of light touch determined with Transcutaneous Electric Nerve Stimulation at the index finger.
Time Frame
within 4 months post stroke
Title
Nine Hole Peg test
Description
manual dexterity
Time Frame
within 4 months post stroke
Title
Stroke Upper Limb Capacity Scale
Description
upper limb capacity by the means of ten functional and meaningful tasks related to daily live activities
Time Frame
within 4 months post stroke
Title
functional connectivity
Description
resting-state fMRI functional connectivity between Regions of Interest of the sensorimotor network
Time Frame
within 4 months post stroke

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geert Verheyden
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
KU Leuven
City
Leuven
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21350049
Citation
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.
Results Reference
result
PubMed Identifier
33343498
Citation
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.
Results Reference
derived
PubMed Identifier
29678195
Citation
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.
Results Reference
derived

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Brain-behavior Associations of Sensorimotor Therapy Post Stroke

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