StrokeNCT07623512
fNIRS for Monitoring Cortical Activity in Stroke Recovery
A study testing Robot-assisted therapy (EE or EXO system) and functional training in people with Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This clinical trial aims to investigate the mechanisms of brain reorganization underlying motor recovery following end-effector (EE) and exoskeleton (Exo) robot-assisted hand training in individuals with stroke. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Robot-assisted therapy (EE or EXO system) and functional training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Nov 2025to 31 Dec 2028
- 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
- unilateral stroke onset ≥ 3 months
- Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score between 18 to 56 - modified Ashworth scale ≤ 3 in proximal joints and modified Ashworth scale ≤ 2 in distal joints
- able to follow 2-step instructions
- without excessive spasticity in any of the UE joints.
Who cannot join
- orthopedic conditions affecting the arm/hand or other neurological conditions
- severe pain that prevents movement in the affected arm and hand
- implanted cardiac pacemakers and cardioverter-defibrillators
- osteoporosis, fracture, or severe ataxia
- unstable medical status
- participating in other rehabilitation or drug studies simultaneously
Show all 10Show fewer
- receiving Botulinum toxin injections within 3 months
- Healthy participants
- have no neurological conditions
- have no musculoskeletal disorders affecting the UE
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
Chang Gung Memorial Hospital
Taoyuan, 333
Chieh-ling Yang, 03-2118800 ext. 3058, chieh-ling.yang@cgu.edu.tw
About this study
Official title: Functional Near-infrared Spectroscopy (fNIRS) is an Ideal Tool to Monitor Cortical Brain Activity and Understand the Mechanism Underlying Recovery Following Stroke
This clinical trial aims to investigate the mechanisms of brain reorganization underlying motor recovery following end-effector (EE) and exoskeleton (Exo) robot-assisted hand training in individuals with stroke. Using functional near-infrared spectroscopy (fNIRS), the study will (1) investigate brain activation patterns during EE and Exo robot-assisted hand movements in healthy adults and individuals with stroke and (2) examine longitudinal changes in brain activation and motor recovery over a 6-week intervention.
For Part 1, a cross-sectional observational study will be conducted to examine brain activation using fNIRS while participants perform EE and Exo robot-assisted movements. Healthy adults and individuals with stroke will each perform one session of each type of robot-assisted movement.
Read more
For Part 2, an evaluator-blinded randomized controlled design will be used. Participants will be stratified based on the level of motor impairment and the side of the brain lesion and then randomly assigned to either the EE or Exo robot-assisted training group. Both groups will receive training 3 times per week, with each session lasting 60 minutes, for a total of 6 weeks. Each session will include 40 minutes of robot-assisted therapy and 20 minutes of functional training.
Outcome assessments will be conducted at four time points: prior to the intervention (baseline), mid-intervention (during weeks 3-4 of the intervention), immediately after the intervention, and at the 3-month post-trial follow-up. These assessments will be used to evaluate motor recovery and longitudinal changes in brain function.
- Conditions
- Stroke
- Being tested
- Robot-assisted therapy (EE or EXO system) and functional training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted therapy (EE or EXO system) and functional trainingDevice
Each group will receive intervention 3 times per week, 60 minutes per session, for a total duration of 6 weeks. The intervention will consist of 40 minutes of robot-assisted therapy and 20 minutes of functional training. For the robot-assisted therapy, participants will receive training using either the EE or EXO system according to group allocation. The functional training component will be conducted without robotic assistance and will focus on task-oriented activities to facilitate the transfer of motor learning to functional performance.
| Study group | Role | What they receive |
|---|---|---|
| End-Effector (EE) robot-assisted training group | Experimental | Robot-assisted therapy (EE system) and functional training Receives: Device: Robot-assisted therapy (EE or EXO system) and functional training |
| Exoskeleton (EXO) robot-assisted training group. | Experimental | Robot-assisted therapy (EXO system) and functional training Receives: Device: Robot-assisted therapy (EE or EXO system) and functional training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Task-related changes in oxyhemoglobin (HbO) concentration measured using functional near-infrared spectroscopy (fNIRS)
Cortical activation will be quantified as task-related changes in oxyhemoglobin (HbO) measured using functional near-infrared spectroscopy (fNIRS) during robot-assisted movements and upper extremity functional tasks (e.g., shoulder abduction, finger extension, and grasping).
Measured: Assessments will be conducted at baseline, mid-intervention (during weeks 3-4 of the intervention), immediately after the intervention, and at the 3-month post-trial follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start28 Nov 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chieh-ling Yang, Chang Gung Memorial Hospital
- Investigators
- Chieh-ling Yang, Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623512
- Sponsor's protocol ID
- 202400386B0
- Status last verified
- Jun 2026
- First submitted
- 21 May 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Near-infrared Spectroscopy (fNIRS) is an Ideal Tool to Monitor Cortical Brain Activity and Understand the Mechanism Underlying Recovery Following Stroke
- ClinicalTrials.gov ID
- NCT07623512
- Acronym / sponsor ID
- 202400386B0
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 28 Nov 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Jun 2026 (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.
This clinical trial aims to investigate the mechanisms of brain reorganization underlying motor recovery following end-effector (EE) and exoskeleton (Exo) robot-assisted hand training in individuals with stroke. Using functional near-infrared spectroscopy (fNIRS), the study will (1) investigate brain activation patterns during EE and Exo robot-assisted hand movements in healthy adults and individuals with stroke and (2) examine longitudinal changes in brain activation and motor recovery over a 6-week intervention.
For Part 1, a cross-sectional observational study will be conducted to examine brain activation using fNIRS while participants perform EE and Exo robot-assisted movements. Healthy adults and individuals with stroke will each perform one session of each type of robot-assisted movement.
For Part 2, an evaluator-blinded randomized controlled design will be used. Participants will be stratified based on the level of motor impairment and the side of the brain lesion and then randomly assigned to either the EE or Exo robot-assisted training group. Both groups will receive training 3 times per week, with each session lasting 60 minutes, for a total of 6 weeks. Each session will include 40 minutes of robot-assisted therapy and 20 minutes of functional training.
Outcome assessments will be conducted at four time points: prior to the intervention (baseline), mid-intervention (during weeks 3-4 of the intervention), immediately after the intervention, and at the 3-month post-trial follow-up. These assessments will be used to evaluate motor recovery and longitudinal changes in brain function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| End-Effector (EE) robot-assisted training group | Experimental | Device: Robot-assisted therapy (EE or EXO system) and functional trainingRobot-assisted therapy (EE system) and functional training |
| Exoskeleton (EXO) robot-assisted training group. | Experimental | Device: Robot-assisted therapy (EE or EXO system) and functional trainingRobot-assisted therapy (EXO system) and functional training |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- unilateral stroke onset ≥ 3 months
- Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score between 18 to 56 - modified Ashworth scale ≤ 3 in proximal joints and modified Ashworth scale ≤ 2 in distal joints
- able to follow 2-step instructions
- without excessive spasticity in any of the UE joints.
Key exclusion criteria (10 listed)
- orthopedic conditions affecting the arm/hand or other neurological conditions
- severe pain that prevents movement in the affected arm and hand
- implanted cardiac pacemakers and cardioverter-defibrillators
- osteoporosis, fracture, or severe ataxia
- unstable medical status
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 |
|---|---|---|
| Robot-assisted therapy (EE or EXO system) and functional trainingEach group will receive intervention 3 times per week, 60 minutes per session, for a total duration of 6 weeks. The intervention will consist of 40 minutes of robot-assisted therapy and 20 minutes of functional training. For the robot-assisted therapy, participants will receive training using either the EE or EXO system according to group allocation. The functional training component will be conducted without robotic assistance and will focus on task-oriented activities to facilitate the transfer of motor learning to functional performance. | Device | End-Effector (EE) robot-assisted training group, Exoskeleton (EXO) robot-assisted training group. |
Primary outcome
Task-related changes in oxyhemoglobin (HbO) concentration measured using functional near-infrared spectroscopy (fNIRS)
Time frame: Assessments will be conducted at baseline, mid-intervention (during weeks 3-4 of the intervention), immediately after the intervention, and at the 3-month post-trial follow-up.
Cortical activation will be quantified as task-related changes in oxyhemoglobin (HbO) measured using functional near-infrared spectroscopy (fNIRS) during robot-assisted movements and upper extremity functional tasks (e.g., shoulder abduction, finger extension, and grasping).
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 16 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Chieh-ling Yang principal investigator
Chang Gung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted therapy (EE or EXO system) and functional training in people with Stroke, run by Chang Gung Memorial 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 4 inclusion and 10 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 16 Jun 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 Chieh_ling Yang (03-2118800 ext. 3058, chieh-ling.yang@cgu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Task-related changes in oxyhemoglobin (HbO) concentration measured using functional near-infrared spectroscopy (fNIRS) (time frame: Assessments will be conducted at baseline, mid-intervention (during weeks 3-4 of the intervention), immediately after the intervention, and at the 3-month post-trial follow-up.). 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 16 Jun 2026.