StrokeNCT06113380
Using Upper Limb Rehabilitation Robot in Stroke Patient Rehabilitation
A study testing NTUH-ii, am upper limb rehabilitation robot arm and Traditional upper limb physical therapy in people with Stroke and Rehabilitation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
A robot arm for upper limb rehabilitation is intended to achieve rehabilitation effects through the study of robot control theory and the integration of sensors such as sEMG. The goal is to reduce the workload of rehabilitation therapists. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Stroke, Rehabilitation
- What is being tested?
- NTUH-ii, am upper limb rehabilitation robot arm and Traditional upper limb physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Oct 2023to 30 Jul 2026
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First-time stroke, occurring between 2 weeks and 2 years after onset, resulting in unilateral hemiplegia.
- Able to understand and follow simple instructions.
- Able to maintain a sitting posture balance.
- Rank on the Brunnstrom Scale is between two and five.
- Both ischemic and hemorrhagic strokes are included.
Who cannot join
- Not yet fully conscious.
- Suffering from a psychiatric disorder or post-stroke psychiatric abnormalities.
- Cognitive or behavioral impairments that affect the ability to comprehend or execute the experimental tasks.
- Severe aphasia preventing compliance with researchers' instructions for this study.
- Medical conditions in internal medicine that jeopardize patient safety, such as severe heart or lung diseases, or patients requiring bed rest.
- Patients with a severe systemic illness requiring bed rest.
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- Patients with shoulder joint pathology unable to undergo exercise therapy.
- Patients with severe osteoporosis who have concerns about fractures during physical activity.
- Patients with arrhythmia and implanted cardiac pacemakers.
- Severe uncontrolled seizures that cannot be improved with medication, physical therapy, botulinum toxin injections, or phenol block procedures.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Meng Ting Lin, M.D., +886-2312-3456 ext 67048, mntinglin@ntuh.gov.tw
About this study
Official title: Effect on Upper Limb Training Using Rehabilitation Robot With Human-Computer Interaction Game Interface for Stroke Patients
A robot arm for upper limb rehabilitation is intended to achieve rehabilitation effects through the study of robot control theory and the integration of sensors such as sEMG. The goal is to reduce the workload of rehabilitation therapists.
Read the detailed description
NTUH-ii is an upper limb rehabilitation robot. The aim of this robot is to reduce the workload of rehabilitation therapists and make the rehabilitation process more effective.
The robot can complete rehabilitation tasks, such as elbow flexion/extension, shoulder flexion/extension, and shoulder horizontal abduction/adduction, etc. By giving the desired trajectory, the robot can lead patients to do the tasks in passive mode or active mode.
However, curative rehabilitation should include the motion intention of patients. This study aimed to investigate the efficacy of rehabilitation effect by combining the sensors (such as sEMG, IMU) to obtain the motion intention of patients and give the assistive movement.
- Conditions
- Stroke, Rehabilitation
- Being tested
- NTUH-ii, am upper limb rehabilitation robot arm, Traditional upper limb physical therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTUH-ii, am upper limb rehabilitation robot armDevice
Rehabilitation programs are planned based on the subject's capabilities, and the differences between assisted rehabilitation with a robot and traditional rehabilitation are compared.
Traditional upper limb physical therapyOther
Traditional upper limb physical therapy is performed by the therapist.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation by rehabilitation robot | Experimental | Rehabilitation therapists will determine the training mode based on the subject's movement ability.
Passive training mode Active-assistive training mode Receives: Device: NTUH-ii, am upper limb rehabilitation robot arm |
| Traditional rehabilitation | Active comparator | Traditional upper limb physical therapy is performed by the therapist. Receives: Other: Traditional upper limb physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment
Fugl-Meyer assessment upper extremity, higher scores indicate a better outcome.
Measured: 1 month
Secondary outcomes (6)
Fugl-Meyer Assessment
Fugl-Meyer assessment upper extremity, higher scores indicate a better outcome.
Measured: Before the task and right away the experiment, 3 months, 6 months post intervention.
sEMG analyzation
using sEMG sensors to obtain the sEMG signal and applying 3×2 ANOVA to analyze.
Measured: Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.
Modified Ashworth Scale
To measure the increase of muscle tone, score from 0 to 4, higher scores indicate the higher muscle tone.
Measured: Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.
Wolf Motor Function Test
To quantify upper extremity movement ability through timed single- or multiple-joint motions .and functional tasks.
Measured: Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.
Stroke Impact Scale
A self-report questionnaire that evaluates disability and health-related quality of life after stroke. Score from 0 to 100, Higher scores indicate a better outcome.
Measured: Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.
Motor evoked potential
action potential elicited by noninvasive stimulation of the motor cortex
Measured: Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start25 Oct 2023
- Primary completion22 Dec 2025 (estimated)
- Study completion30 Jul 2026 (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 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
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113380
- Sponsor's protocol ID
- 201905073DINC
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2023
- Last updated
- 4 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Upper Limb Training Using Rehabilitation Robot With Human-Computer Interaction Game Interface for Stroke Patients
- ClinicalTrials.gov ID
- NCT06113380
- Acronym / sponsor ID
- 201905073DINC
- Conditions
- Stroke, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 22 Dec 2025 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 2 Nov 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.
A robot arm for upper limb rehabilitation is intended to achieve rehabilitation effects through the study of robot control theory and the integration of sensors such as sEMG. The goal is to reduce the workload of rehabilitation therapists.
Detailed description
NTUH-ii is an upper limb rehabilitation robot. The aim of this robot is to reduce the workload of rehabilitation therapists and make the rehabilitation process more effective.
The robot can complete rehabilitation tasks, such as elbow flexion/extension, shoulder flexion/extension, and shoulder horizontal abduction/adduction, etc. By giving the desired trajectory, the robot can lead patients to do the tasks in passive mode or active mode.
However, curative rehabilitation should include the motion intention of patients. This study aimed to investigate the efficacy of rehabilitation effect by combining the sensors (such as sEMG, IMU) to obtain the motion intention of patients and give the assistive movement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation by rehabilitation robot | Experimental | Device: NTUH-ii, am upper limb rehabilitation robot armRehabilitation therapists will determine the training mode based on the subject's movement ability. Passive training mode Active-assistive training mode |
| Traditional rehabilitation | Active comparator | Other: Traditional upper limb physical therapyTraditional upper limb physical therapy is performed by the therapist. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- First-time stroke, occurring between 2 weeks and 2 years after onset, resulting in unilateral hemiplegia.
- Able to understand and follow simple instructions.
- Able to maintain a sitting posture balance.
- Rank on the Brunnstrom Scale is between two and five.
- Both ischemic and hemorrhagic strokes are included.
Key exclusion criteria (10 listed)
- Not yet fully conscious.
- Suffering from a psychiatric disorder or post-stroke psychiatric abnormalities.
- Cognitive or behavioral impairments that affect the ability to comprehend or execute the experimental tasks.
- Severe aphasia preventing compliance with researchers' instructions for this study.
- Medical conditions in internal medicine that jeopardize patient safety, such as severe heart or lung diseases, or patients requiring bed rest.
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 |
|---|---|---|
| NTUH-ii, am upper limb rehabilitation robot armRehabilitation programs are planned based on the subject's capabilities, and the differences between assisted rehabilitation with a robot and traditional rehabilitation are compared. | Device | Rehabilitation by rehabilitation robot |
| Traditional upper limb physical therapyTraditional upper limb physical therapy is performed by the therapist. | Other | Traditional rehabilitation |
Primary outcome
Fugl-Meyer Assessment
Time frame: 1 month
Fugl-Meyer assessment upper extremity, higher scores indicate a better outcome.
6 secondary outcomes
Fugl-Meyer Assessment
Time frame: Before the task and right away the experiment, 3 months, 6 months post intervention.
sEMG analyzation
Time frame: Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.
Modified Ashworth Scale
Time frame: Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.
Wolf Motor Function Test
Time frame: Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.
Stroke Impact Scale
Time frame: Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.
Motor evoked potential
Time frame: Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Stroke
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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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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NTUH-ii, am upper limb rehabilitation robot arm and Traditional upper limb physical therapy in people with Stroke and Rehabilitation, 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 5 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: status not confirmed, as of the sponsor's last update on 4 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meng Ting Lin, M.D. (+886-2312-3456 ext 67048, mntinglin@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment (time frame: 1 month). 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 4 Mar 2024.