StrokeNCT03236376
Brain-behavior Associations of Sensorimotor Therapy Post Stroke
A study testing additional sensorimotor therapy for the upper limb and additional motor therapy for the upper limb after stroke in people with Stroke, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- additional sensorimotor therapy for the upper limb and additional motor therapy for the upper limb after stroke
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Sep 2017to 6 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- additional sensorimotor therapy for the upper limb, additional motor therapy for the upper limb after stroke
- Keywords
- upper limb, somatosensory impairments, motor impairments, brain imaging
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
additional sensorimotor therapy for the upper limbOther
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 strokeOther
The intervention will consist of additional physiotherapy for the upper limb after stroke consisting of cognitive-attention based training and motor training
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: additional motor therapy for the upper limb after stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test
grasp, grip, pinch and gross movement of the affected arm and hand
Measured: within 4 months post stroke
Secondary outcomes (7)
Fugl-Meyer motor Assessment-upper Extremity
overall motor impairment of the affected upper limb: shoulder, arm, wrist , hand and fingers
Measured: 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
Measured: within 4 months post stroke
Erasmus modified Nottingham Sensory Assessment
light touch, pressure, sharp, sharp-dull discrimination, position sense of the arm and hand
Measured: within 4 months post stroke
Perceptual Threshold of Touch
threshold of light touch determined with Transcutaneous Electric Nerve Stimulation at the index finger.
Measured: within 4 months post stroke
Nine Hole Peg test
manual dexterity
Measured: 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
Measured: within 4 months post stroke
functional connectivity
resting-state fMRI functional connectivity between Regions of Interest of the sensorimotor network
Measured: within 4 months post stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start21 Sep 2017
- Primary completion1 Dec 2017
- Study completion6 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled Trial with two therapy groups ( experimental and control therapy) and one healthy control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders, KU Leuven
- Responsible party
- Principal investigator, Geert Verheyden, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Geert Verheyden, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236376
- Sponsor's protocol ID
- s60278
- Status last verified
- Jan 2020
- First submitted
- 20 Jun 2017
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 21350049De 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.
PubMed 33343498De 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.
PubMed 29678195
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral and Brain Connectivity Analysis of Upper Limb Sensorimotor Rehabilitation Post Stroke: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03236376
- Acronym / sponsor ID
- s60278
- Conditions
- Stroke
- Keywords
- upper limb, somatosensory impairments, motor impairments, brain imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Research Foundation Flanders, KU Leuven
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 6 Jan 2020 (actual)
- First posted
- 1 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled Trial with two therapy groups ( experimental and control therapy) and one healthy control group
| Arm | Type | Receives |
|---|---|---|
| sensorimotor therapy | Experimental | Other: additional sensorimotor therapy for the upper limbsensorimotor 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. |
| motor therapy | Active comparator | Other: additional motor therapy for the upper limb after strokeThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| additional sensorimotor therapy for the upper limbThe intervention will consist of additional physiotherapy for the upper limb after stroke consisting of sensory discrimination training and sensorimotor training. | Other | sensorimotor therapy |
| additional motor therapy for the upper limb after strokeThe intervention will consist of additional physiotherapy for the upper limb after stroke consisting of cognitive-attention based training and motor training | Other | motor therapy |
Primary outcome
Action Research Arm Test
Time frame: within 4 months post stroke
grasp, grip, pinch and gross movement of the affected arm and hand
7 secondary outcomes
Fugl-Meyer motor Assessment-upper Extremity
Time frame: within 4 months post stroke
composite standardized somatosensory deficit index
Time frame: within 4 months post stroke
Erasmus modified Nottingham Sensory Assessment
Time frame: within 4 months post stroke
Perceptual Threshold of Touch
Time frame: within 4 months post stroke
Nine Hole Peg test
Time frame: within 4 months post stroke
Stroke Upper Limb Capacity Scale
Time frame: within 4 months post stroke
functional connectivity
Time frame: within 4 months post stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Results publication: PubMed 21350049Carey 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.
- Derived from this study: PubMed 33343498De 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.
- Derived from this study: PubMed 29678195De 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geert Verheyden principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing additional sensorimotor therapy for the upper limb and additional motor therapy for the upper limb after stroke in people with Stroke, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Action Research Arm Test (time frame: within 4 months post stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03236376, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.