Chronic StrokeNCT06057584
Effect of Somatosensory Motor Intergration Training on Post-stroke Upper Limb Function.
A study testing somatosensory-motor integration training, pure somatosensory training and pure motor training in people with Chronic Stroke, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Background: Most patients suffer from post-stroke somatosensory and motor impairments, and 50% to 70% of patients in the chronic stage still have upper extremity impairments that severely limit their functional independence and quality of life. Somatosensory and motor functions are closely related to each other. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- somatosensory-motor integration training, pure somatosensory training and pure motor training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Oct 2023to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 20.
- Diagnosed with stroke.
- Stroke duration ≥ 6 months.
- Upper limb Brunnstrom stage III-V.
- No severe muscle spasticity (Modified Ashworth Scale ≤ 2) in all segments of the affected upper limb.
- Self-perceived or therapist-assessed somatosensory impairment.
Who cannot join
- Significant cognitive impairment (Montreal Cognitive Assessment < 20).
- Severe mental disorders (e.g., schizophrenia, major depression).
- Substance abuse or alcoholism.
- Claustrophobia.
- Severe aphasia affecting comprehension and clear expression of somatosensory information.
- Hemineglect.
- Other muscle or joint problems affecting upper limb function (e.g., contractures, rheumatoid arthritis, myositis ossificans).
- Concurrent participation in other somatosensory or motor therapy studies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan
I-Ping Hsueh, Professor, +886233668174, iping@ntu.edu.tw
About this study
Official title: The Neural Mechanism and Efficacy of Somatosensory Motor Intergration Training on the Upper Extremity Somatosensory Motor Function in Patients With Chronic Stroke.
Background: Most patients suffer from post-stroke somatosensory and motor impairments, and 50% to 70% of patients in the chronic stage still have upper extremity impairments that severely limit their functional independence and quality of life. Somatosensory and motor functions are closely related to each other. Previous evidence showed that somatosensory training or stimulation can modulate motor performance and enhance the efficacy of motor training, and motor training has the potential to promote the reorganization of the somatosensory cortex and enhance somatosensory-motor integration. Therefore, combining somatosensory and motor training may optimize the recovery of upper limb function. However, due to the small number of relevant empirical studies and the low quality of evidence, the effects and neural mechanisms of combined somatosensory and motor training compared with pure somatosensory training or pure motor training are still unknown or uncertain.
Purposes: This project will compare the immediate and long-term effects of somatosensory-motor integration training, pure motor training, and pure somatosensory training on the somatosensory and motor functions of patients with chronic stroke, and will investigate the neural mechanisms of somatosensory-motor recovery using neuroimaging and neurophysiological techniques.
Read more
Research methods: A single-blind (assessor-blinded) randomized controlled trial design will be used in this three-year project. A sample of 153 patients with chronic stroke will be recruited, and subjects who meet the selection criteria will undergo a baseline assessment and then be randomly assigned in stratified blocks to either the somatosensory-motor integration training group, pure somatosensory training group or pure motor training group. Subjects will receive three to five 60-minute sessions per week for a total of 15 sessions, followed by post-intervention (immediate effect) and three-month follow-up (long-term effect) assessments. Outcome measures will include neuroimaging (functional near-infrared spectroscopy.), and clinical scales (somatosensory function, motor function, upper extremity function, real life functional upper extremity performance., daily activities, and quality of life). The data will be analyzed using intention-to-treat analysis. The treatment effects within each group will be determined by paired t tests. The difference in effects among the three groups will be analyzed by analyses of covariate. Multiple linear regressions will also be used to explore the factors affecting the recovery of somatosensory and motor functions.
Expected results and contributions: The researchers expect that somatosensory-motor integration training, pure somatosensory training and pure motor training can all effectively improve the somatosensory and motor functions of patients with stroke. Among the three groups, somatosensory-motor integration training will show the greatest improvement in upper extremity function. The results of this project will provide empirical evidence on the effects and neural mechanisms of somatosensory-motor integration training, which will help clinicians select appropriate treatment strategies, facilitate clinical reasoning, and predict the recovery potential of somatosensory-motor function based on patient characteristics.
- Conditions
- Chronic Stroke
- Being tested
- somatosensory-motor integration training, pure somatosensory training, pure motor training
- Keywords
- stroke, somatosensory-motor integration, somatosensory, motor, randomized controlled trial
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatosensory-motor integration trainingBehavioural
Participants will use both hands to perform functional tasks requiring somatosensory discrimination to provide different somatosensory stimuli to facilitate motor control. The experimental group will receive somatosensory-motor integration training, 3-5 sessions a week, for a total of 15 sessions.
pure somatosensory trainingBehavioural
Participants will use the affected hand to perform somatosensory discrimination tasks, including limb position discrimination and object discrimination.The experimental group will receive pure somatosensory integration training, 3-5 sessions a week, for a total of 15 sessions.
pure motor trainingBehavioural
Participants will conduct bilateral task-oriented training, but the training task does not require somatosensory discrimination. Each round only uses the same target and target position to repeatedly practice the functional task movements, but the target or target position is different in different rounds. The experimental group will receive pure motor integration training, 3-5 sessions a week, for a total of 15 sessions.
| Study group | Role | What they receive |
|---|---|---|
| somatosensory-motor integration training | Experimental | Not described Receives: Behavioral: somatosensory-motor integration training |
| pure somatosensory training | Active comparator | Not described Receives: Behavioral: pure somatosensory training |
| pure motor training | Active comparator | Not described Receives: Behavioral: pure motor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre- and 3-month change in cerebral hemodynamics evaluated by functional near-infrared spectroscopy (fNIRS)
fNIRS collects cerebral hemodynamic parameters in the bi-hemispheric sensory-motor cortices to estimate the changes in functional activation and functional connection of the corresponding brain areas before and after the intervention. The fNIRS system uses near-infrared light with two wavelengths of 760 nm and 850 nm, and 8 LED light sources and 8 sensors will be placed on the scalp of the sensory-action cortex of the left and right brain of the subject.
Measured: Pre- and post-test (up to 5 weeks) and three-month follow-up
Pre- and 3-month change in functional ability of the upper extremities assessed by Action Research Arm Test (ARAT)
The ARAT is an operant test that assesses functional ability of the upper extremities. It includes grasping, holding, pinching, and gross motor. Higher scores represent better upper body functional capacity.
Measured: Pre- and post-test (up to 5 weeks) and three-month follow-up
Pre- and 3-month change in motor function of the upper limbs assessed by Fugl-Meyer Assessment of Upper Extremity (FMA-UE)
The FMA-UE evaluates the motor function of the upper limbs. The higher the score, the better the motor function of the upper limbs.
Measured: Pre- and post-test (up to 5 weeks) and three-month follow-up
Pre- and 3-month change in sensation assessed by Revised Nottingham Sensory Assessment (rNSA)
The rNSA evaluates the tactile sense of the face, trunk and upper and lower extremities. The tactile sense includes light touch, temperature, pinprick, pressure, tactile localization and sensory extinction. Stereognosis and proprioception will also be evaluated. Higher scores represent better somatosensory function.
Measured: Pre- and post-test (up to 5 weeks) and three-month follow-up
Pre- and 3-month change in sensation assessed by Rivermead Assessment of Somatosensory Performance (RASP)
The RASP assesses sharp/dull discrimination, surface pressure touch, surface localization, temperature discrimination, sensory extinction, two-point discrimination, and proprioception. Higher scores represent better somatosensory function.
Measured: Pre- and post-test (up to 5 weeks) and three-month follow-up
Secondary outcomes (3)
Pre- and 3-month change in the frequency and movement quality in daily use of the affected upper limb assessed by Motor Activity Log (MAL)
The MAL evaluates the frequency and movement quality in daily use of the affected upper limb in patients with stroke or traumatic brain injury. The higher the score, the better the use frequency or movement quality of the affected upper limb.
Measured: Pre- and post-test (up to 5 weeks) and three-month follow-up
Pre- and 3-month change in the performance, self-perceived difficulty, and ability of basic activities of daily living (ADL) assessed by The Barthel Index-based Supplementary Scales (BI-SS)
The BI-SS and BI comprehensively evaluate the performance, self-perceived difficulty, and ability of basic activities of daily living (ADL) . Higher scores represent better ADL performance, greater ADL ability, and simpler perceptions of ADL.
Measured: Pre- and post-test (up to 5 weeks) and three-month follow-up
Pre- and 3-month change in the quality of life in patients assessed by Stroke Impact Scale 3.0 (ML-SIS)
The ML-SIS, a short version of the Stroke Impact Scale 3.0 based on machine learning methods, evaluates the quality of life in patients with stroke. It includes strength, memory, emotion, communication, activities of daily living, mobility, hand function and social participation. Higher scores represent better health-related quality of life.
Measured: Pre- and post-test (up to 5 weeks) and three-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start11 Oct 2023
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057584
- Sponsor's protocol ID
- 202302039RINB
- Status last verified
- Feb 2026
- First submitted
- 8 Sep 2023
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neural Mechanism and Efficacy of Somatosensory Motor Intergration Training on the Upper Extremity Somatosensory Motor Function in Patients With Chronic Stroke.
- ClinicalTrials.gov ID
- NCT06057584
- Acronym / sponsor ID
- 202302039RINB
- Conditions
- Chronic Stroke
- Keywords
- stroke, somatosensory-motor integration, somatosensory, motor, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 28 Sep 2023 (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.
Background: Most patients suffer from post-stroke somatosensory and motor impairments, and 50% to 70% of patients in the chronic stage still have upper extremity impairments that severely limit their functional independence and quality of life. Somatosensory and motor functions are closely related to each other. Previous evidence showed that somatosensory training or stimulation can modulate motor performance and enhance the efficacy of motor training, and motor training has the potential to promote the reorganization of the somatosensory cortex and enhance somatosensory-motor integration. Therefore, combining somatosensory and motor training may optimize the recovery of upper limb function. However, due to the small number of relevant empirical studies and the low quality of evidence, the effects and neural mechanisms of combined somatosensory and motor training compared with pure somatosensory training or pure motor training are still unknown or uncertain.
Purposes: This project will compare the immediate and long-term effects of somatosensory-motor integration training, pure motor training, and pure somatosensory training on the somatosensory and motor functions of patients with chronic stroke, and will investigate the neural mechanisms of somatosensory-motor recovery using neuroimaging and neurophysiological techniques.
Research methods: A single-blind (assessor-blinded) randomized controlled trial design will be used in this three-year project. A sample of 153 patients with chronic stroke will be recruited, and subjects who meet the selection criteria will undergo a baseline assessment and then be randomly assigned in stratified blocks to either the somatosensory-motor integration training group, pure somatosensory training group or pure motor training group. Subjects will receive three to five 60-minute sessions per week for a total of 15 sessions, followed by post-intervention (immediate effect) and three-month follow-up (long-term effect) assessments. Outcome measures will include neuroimaging (functional near-infrared spectroscopy.), and clinical scales (somatosensory function, motor function, upper extremity function, real life functional upper extremity performance., daily activities, and quality of life). The data will be analyzed using intention-to-treat analysis. The treatment effects within each group will be determined by paired t tests. The difference in effects among the three groups will be analyzed by analyses of covariate. Multiple linear regressions will also be used to explore the factors affecting the recovery of somatosensory and motor functions.
Expected results and contributions: The researchers expect that somatosensory-motor integration training, pure somatosensory training and pure motor training can all effectively improve the somatosensory and motor functions of patients with stroke. Among the three groups, somatosensory-motor integration training will show the greatest improvement in upper extremity function. The results of this project will provide empirical evidence on the effects and neural mechanisms of somatosensory-motor integration training, which will help clinicians select appropriate treatment strategies, facilitate clinical reasoning, and predict the recovery potential of somatosensory-motor function based on patient characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| somatosensory-motor integration training | Experimental | Behavioral: somatosensory-motor integration training |
| pure somatosensory training | Active comparator | Behavioral: pure somatosensory training |
| pure motor training | Active comparator | Behavioral: pure motor training |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 20.
- Diagnosed with stroke.
- Stroke duration ≥ 6 months.
- Upper limb Brunnstrom stage III-V.
- No severe muscle spasticity (Modified Ashworth Scale ≤ 2) in all segments of the affected upper limb.
Key exclusion criteria (8 listed)
- Significant cognitive impairment (Montreal Cognitive Assessment < 20).
- Severe mental disorders (e.g., schizophrenia, major depression).
- Substance abuse or alcoholism.
- Claustrophobia.
- Severe aphasia affecting comprehension and clear expression of somatosensory information.
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 |
|---|---|---|
| somatosensory-motor integration trainingParticipants will use both hands to perform functional tasks requiring somatosensory discrimination to provide different somatosensory stimuli to facilitate motor control. The experimental group will receive somatosensory-motor integration training, 3-5 sessions a week, for a total of 15 sessions. | Behavioural | somatosensory-motor integration training |
| pure somatosensory trainingParticipants will use the affected hand to perform somatosensory discrimination tasks, including limb position discrimination and object discrimination.The experimental group will receive pure somatosensory integration training, 3-5 sessions a week, for a total of 15 sessions. | Behavioural | pure somatosensory training |
| pure motor trainingParticipants will conduct bilateral task-oriented training, but the training task does not require somatosensory discrimination. Each round only uses the same target and target position to repeatedly practice the functional task movements, but the target or target position is different in different rounds. The experimental group will receive pure motor integration training, 3-5 sessions a week, for a total of 15 sessions. | Behavioural | pure motor training |
Primary outcome
Pre- and 3-month change in cerebral hemodynamics evaluated by functional near-infrared spectroscopy (fNIRS)
Time frame: Pre- and post-test (up to 5 weeks) and three-month follow-up
fNIRS collects cerebral hemodynamic parameters in the bi-hemispheric sensory-motor cortices to estimate the changes in functional activation and functional connection of the corresponding brain areas before and after the intervention. The fNIRS system uses near-infrared light with two wavelengths of 760 nm and 850 nm, and 8 LED light sources and 8 sensors will be placed on the scalp of the sensory-action cortex of the left and right brain of the subject.
Pre- and 3-month change in functional ability of the upper extremities assessed by Action Research Arm Test (ARAT)
Time frame: Pre- and post-test (up to 5 weeks) and three-month follow-up
The ARAT is an operant test that assesses functional ability of the upper extremities. It includes grasping, holding, pinching, and gross motor. Higher scores represent better upper body functional capacity.
Pre- and 3-month change in motor function of the upper limbs assessed by Fugl-Meyer Assessment of Upper Extremity (FMA-UE)
Time frame: Pre- and post-test (up to 5 weeks) and three-month follow-up
The FMA-UE evaluates the motor function of the upper limbs. The higher the score, the better the motor function of the upper limbs.
Pre- and 3-month change in sensation assessed by Revised Nottingham Sensory Assessment (rNSA)
Time frame: Pre- and post-test (up to 5 weeks) and three-month follow-up
The rNSA evaluates the tactile sense of the face, trunk and upper and lower extremities. The tactile sense includes light touch, temperature, pinprick, pressure, tactile localization and sensory extinction. Stereognosis and proprioception will also be evaluated. Higher scores represent better somatosensory function.
Pre- and 3-month change in sensation assessed by Rivermead Assessment of Somatosensory Performance (RASP)
Time frame: Pre- and post-test (up to 5 weeks) and three-month follow-up
The RASP assesses sharp/dull discrimination, surface pressure touch, surface localization, temperature discrimination, sensory extinction, two-point discrimination, and proprioception. Higher scores represent better somatosensory function.
3 secondary outcomes
Pre- and 3-month change in the frequency and movement quality in daily use of the affected upper limb assessed by Motor Activity Log (MAL)
Time frame: Pre- and post-test (up to 5 weeks) and three-month follow-up
Pre- and 3-month change in the performance, self-perceived difficulty, and ability of basic activities of daily living (ADL) assessed by The Barthel Index-based Supplementary Scales (BI-SS)
Time frame: Pre- and post-test (up to 5 weeks) and three-month follow-up
Pre- and 3-month change in the quality of life in patients assessed by Stroke Impact Scale 3.0 (ML-SIS)
Time frame: Pre- and post-test (up to 5 weeks) and three-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
Related trials for Chronic Stroke
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Recruiting
Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke
Stroke, Ischemic, Chronic Stroke
RecruitingPhase 3
A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)
Atherosclerosis Cardiovascular Disease, Chronic Kidney Disease
Not yet recruiting
Proof-of-concept for Use of Transcutaneous Spinal Stimulation (TSS) With the ExaStim® Stimulation System in Adults With Chronic Ischemic Stroke
Chronic Stroke, Ischemic Stroke
Recruiting
Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke
Stroke, Hemiplegia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing somatosensory-motor integration training, pure somatosensory training and pure motor training in people with Chronic Stroke, run by National Taiwan University Hospital at 1 site in Taiwan.
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 3 Mar 2026. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi-jing Huang, Assistant professor (+886-2-33668166, yijinghuang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre- and 3-month change in cerebral hemodynamics evaluated by functional near-infrared spectroscopy (fNIRS) (time frame: Pre- and post-test (up to 5 weeks) and three-month follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2026.