To Understand Whether Increasing the Willingness to Exercise Can Improve Rehabilitation Outcomes (Upper Limb Motor Activation)NCT07398131
Voice-Induced Motor Intention to Enhance Upper Limb Rehabilitation Efficacy of Exoskeleton Robots for Stroke Patients
A study testing single-joint robot (Passive Mode) in people with To Understand Whether Increasing the Willingness to Exercise Can Improve Rehabilitation Outcomes (Upper Limb Motor Activation) and for Patient With Stroke, run by Taipei Hospital, Ministry of Health and Welfare.
Trial summary
This study aims to investigate whether combining "motor imagery" (the mental visualization of movement) with robotic exoskeleton therapy can improve upper limb recovery in stroke patients. Conventional robotic therapy often involves passive movement driven by the machine. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- To Understand Whether Increasing the Willingness to Exercise Can Improve Rehabilitation Outcomes (Upper Limb Motor Activation), for Patient With Stroke
- What is being tested?
- single-joint robot (Passive Mode)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Oct 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic or hemorrhagic stroke diagnosed by CT or MRI
- Stroke onset occurred at least 1 month prior to enrollment
- Aged 20 to 80 years
- Moderate to severe upper limb impairment (Fugl-Meyer Assessment-Upper Extremity score between 13 and 47)
- Cognitive function sufficient to follow instructions (MMSE score > 20)
- Stable medical condition with no severe pain in the affected upper limb
Who cannot join
- Severe spasticity of the affected upper limb (Modified Ashworth Scale score > 2)
- History of other neurological diseases (e.g., Parkinson's disease, brain tumor)
- Serious orthopedic conditions or skin lesions on the affected upper limb that prevent robot use
- Unstable epilepsy or severe psychiatric disorders
- Pregnancy
About this study
This study aims to investigate whether combining "motor imagery" (the mental visualization of movement) with robotic exoskeleton therapy can improve upper limb recovery in stroke patients. Conventional robotic therapy often involves passive movement driven by the machine. In this study, patients in the experimental group will use their own voice to trigger the robot (e.g., saying "bend arm") while simultaneously imagining the movement. The research will compare this voice-enhanced "active" approach with traditional passive robotic training to see if it better promotes brain-to-muscle signal recovery and improves overall arm function .
Read the detailed description
Background and Rationale: Stroke is a leading cause of adult disability, and the "golden period" for rehabilitation requires intensive therapy to trigger muscle movement. Recent theories suggest that combining motor imagery with physical activity-known as Brain-Computer Interface (BCI) concepts-may be more effective than passive movement alone. However, complex EEG-based BCI is difficult to implement clinically. This study proposes a simplified "voice-controlled" interface to simulate the motor intent-to-action loop.
Study Design: This is a randomized, assessor-blinded, parallel-group clinical trial involving 32 subacute or chronic stroke patients. Participants will be randomly assigned to one of two groups for a 4-week intervention (5 sessions per week, 30 minutes per session).
Interventions:
Experimental Group (Voice + Exoskeleton): Patients will use the Nimbo single-joint robot. Before each movement, they will focus on imagining the target action for 2 seconds, then issue a standardized voice command (e.g., "bend hand") to trigger the robotic assistance.
Control Group (Passive Exoskeleton): Patients will receive conventional robotic-assisted training where the Nimbo exoskeleton moves the limb through a preset path without voice prompts or intentional imagery requirements.
Outcome Measures: Evaluations will be conducted at baseline (T0), week 2 (T1), and week 4 (T2).
Primary Outcome: Upper limb motor function measured by the Fugl-Meyer Assessment - Upper Extremity (FMA-UE).
Secondary Outcomes: Brunnstrom stage (recovery phase), KVIQ-10 (subjective imagery), Laterality Judgment Task (objective imagery processing), Sense of Agency (SoA) questionnaire, and System Usability Scale (SUS).
Safety and Monitoring: Safety checks, including pain (NRS), fatigue (RPE), and skin inspections, will be performed after every session. Any adverse events will be reported to the Institutional Review Board (IRB) and data safety monitoring personnel .
- Conditions
- To Understand Whether Increasing the Willingness to Exercise Can Improve Rehabilitation Outcomes (Upper Limb Motor Activation), for Patient With Stroke
- Being tested
- single-joint robot (Active Voice-Controlled Mode), single-joint robot (Passive Mode)
- Keywords
- upper limb motor activation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single-joint robot (Active Voice-Controlled Mode)Device
A robotic exoskeleton used with a voice-trigger interface. Patients perform motor imagery for 2 seconds followed by a voice command to activate the device.
single-joint robot (Passive Mode)Device
The same robotic exoskeleton used in a traditional passive rehabilitation mode where the device moves the limb automatically according to preset parameters.
| Study group | Role | What they receive |
|---|---|---|
| Voice-Enhanced Motor Imagery Group | Experimental | Participants in this group receive upper limb rehabilitation using the Nimbo single-joint robot combined with an "Active Imagery" protocol. Before each movement, patients focus on imagining the target action for 2 seconds and then issue a standardized voice command (e.g., "bend hand") to trigger the robotic assistance. The training is conducted for 30 minutes per session, 5 sessions per week, for a total of 4 weeks. Receives: Device: single-joint robot (Passive Mode) |
| Passive Robotic Training Group | Active comparator | Participants in this group receive conventional passive robotic-assisted rehabilitation using the Nimbo single-joint robot. The robot moves the patient's limb through a preset range of motion automatically. There is no requirement for synchronized motor imagery or voice commands during the session. The training frequency and duration are identical to the experimental group: 30 minutes per session, 5 sessions per week, for 4 weeks. Receives: Device: single-joint robot (Active Voice-Controlled Mode) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
A quantitative measure of upper limb motor recovery. The scale includes 33 items assessing reflexes, movement patterns, and coordination. Scores range from 0 to 66, with higher scores indicating better motor function.
Measured: Baseline (T0), 2 weeks (T1), and 4 weeks (T2).
Secondary outcomes (5)
Brunnstrom Recovery Stage (Upper Limb)
A 6-stage classification system used to categorize the degree of motor recovery in post-stroke hemiplegia, ranging from Stage I (flaccidity) to Stage VI (normal motor function).
Measured: Baseline (T0), 2 weeks (T1), and 4 weeks (T2).
Kinesthetic and Visual Imagery Questionnaire (KVIQ-10)
Evaluates the clarity of visual imagery and intensity of kinesthetic imagery on a 5-point scale. Scores range from 10 to 50; higher scores indicate better imagery ability.
Measured: Baseline (T0), 2 weeks (T1), and 4 weeks (T2).
Laterality Judgment Task (LJT) - Accuracy and Reaction Time
Measures the mental rotation ability by identifying the laterality (left/right) of hand images. Accuracy (percentage) and reaction time (seconds) are recorded.
Measured: Baseline (T0), 2 weeks (T1), and 4 weeks (T2).
Sense of Agency (SoA) Questionnaire
This questionnaire assesses the patient's subjective feeling of control over the robotic movement. It consists of 4 items scored on a 7-point Likert scale, ranging from -3 (strongly disagree) to +3 (strongly agree). The total score is the sum of all items, ranging from -12 to +12. Higher scores indicate a stronger sense of agency (a greater feeling of being the cause of the robotic movement).
Measured: Baseline (T0), 2 weeks (T1), and 4 weeks (T2).
System Usability Scale (SUS)
The System Usability Scale (SUS) is a 10-item instrument for evaluating the usability of the voice-controlled robotic interface. Each item is scored on a 5-point scale from 0 (strongly disagree) to 4 (strongly agree). The final score is calculated by multiplying the sum of the item scores by 2.5, resulting in a total score ranging from 0 to 100. Higher scores indicate better usability and higher user satisfaction.
Measured: 4 weeks (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Understand Whether Increasing the Willingness to Exercise Can Improve Rehabilitation Outcomes (Upper Limb Motor Activation)Studies of the same condition, open and under way.
- 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Hospital, Ministry of Health and Welfare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398131
- Sponsor's protocol ID
- TYGH114109
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voice-Induced Motor Intention to Enhance Upper Limb Rehabilitation Efficacy of Exoskeleton Robots for Stroke Patients
- ClinicalTrials.gov ID
- NCT07398131
- Acronym / sponsor ID
- TYGH114109
- Conditions
- To Understand Whether Increasing the Willingness to Exercise Can Improve Rehabilitation Outcomes (Upper Limb Motor Activation), for Patient With Stroke
- Keywords
- upper limb motor activation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Taipei Hospital, Ministry of Health and WelfareUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 9 Feb 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 study aims to investigate whether combining "motor imagery" (the mental visualization of movement) with robotic exoskeleton therapy can improve upper limb recovery in stroke patients. Conventional robotic therapy often involves passive movement driven by the machine. In this study, patients in the experimental group will use their own voice to trigger the robot (e.g., saying "bend arm") while simultaneously imagining the movement. The research will compare this voice-enhanced "active" approach with traditional passive robotic training to see if it better promotes brain-to-muscle signal recovery and improves overall arm function .
Detailed description
Background and Rationale: Stroke is a leading cause of adult disability, and the "golden period" for rehabilitation requires intensive therapy to trigger muscle movement. Recent theories suggest that combining motor imagery with physical activity-known as Brain-Computer Interface (BCI) concepts-may be more effective than passive movement alone. However, complex EEG-based BCI is difficult to implement clinically. This study proposes a simplified "voice-controlled" interface to simulate the motor intent-to-action loop.
Study Design: This is a randomized, assessor-blinded, parallel-group clinical trial involving 32 subacute or chronic stroke patients. Participants will be randomly assigned to one of two groups for a 4-week intervention (5 sessions per week, 30 minutes per session).
Interventions:
Experimental Group (Voice + Exoskeleton): Patients will use the Nimbo single-joint robot. Before each movement, they will focus on imagining the target action for 2 seconds, then issue a standardized voice command (e.g., "bend hand") to trigger the robotic assistance.
Control Group (Passive Exoskeleton): Patients will receive conventional robotic-assisted training where the Nimbo exoskeleton moves the limb through a preset path without voice prompts or intentional imagery requirements.
Outcome Measures: Evaluations will be conducted at baseline (T0), week 2 (T1), and week 4 (T2).
Primary Outcome: Upper limb motor function measured by the Fugl-Meyer Assessment - Upper Extremity (FMA-UE).
Secondary Outcomes: Brunnstrom stage (recovery phase), KVIQ-10 (subjective imagery), Laterality Judgment Task (objective imagery processing), Sense of Agency (SoA) questionnaire, and System Usability Scale (SUS).
Safety and Monitoring: Safety checks, including pain (NRS), fatigue (RPE), and skin inspections, will be performed after every session. Any adverse events will be reported to the Institutional Review Board (IRB) and data safety monitoring personnel .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Voice-Enhanced Motor Imagery Group | Experimental | Device: single-joint robot (Passive Mode)Participants in this group receive upper limb rehabilitation using the Nimbo single-joint robot combined with an "Active Imagery" protocol. Before each movement, patients focus on imagining the target action for 2 seconds and then issue a standardized voice command (e.g., "bend hand") to trigger the robotic assistance. The training is conducted for 30 minutes per session, 5 sessions per week, for a total of 4 weeks. |
| Passive Robotic Training Group | Active comparator | Device: single-joint robot (Active Voice-Controlled Mode)Participants in this group receive conventional passive robotic-assisted rehabilitation using the Nimbo single-joint robot. The robot moves the patient's limb through a preset range of motion automatically. There is no requirement for synchronized motor imagery or voice commands during the session. The training frequency and duration are identical to the experimental group: 30 minutes per session, 5 sessions per week, for 4 weeks. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ischemic or hemorrhagic stroke diagnosed by CT or MRI
- Stroke onset occurred at least 1 month prior to enrollment
- Aged 20 to 80 years
- Moderate to severe upper limb impairment (Fugl-Meyer Assessment-Upper Extremity score between 13 and 47)
- Cognitive function sufficient to follow instructions (MMSE score > 20)
Key exclusion criteria (5 listed)
- Severe spasticity of the affected upper limb (Modified Ashworth Scale score > 2)
- History of other neurological diseases (e.g., Parkinson's disease, brain tumor)
- Serious orthopedic conditions or skin lesions on the affected upper limb that prevent robot use
- Unstable epilepsy or severe psychiatric disorders
- Pregnancy
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 |
|---|---|---|
| single-joint robot (Active Voice-Controlled Mode)A robotic exoskeleton used with a voice-trigger interface. Patients perform motor imagery for 2 seconds followed by a voice command to activate the device. | Device | Passive Robotic Training Group |
| single-joint robot (Passive Mode)The same robotic exoskeleton used in a traditional passive rehabilitation mode where the device moves the limb automatically according to preset parameters. | Device | Voice-Enhanced Motor Imagery Group |
Primary outcome
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
Time frame: Baseline (T0), 2 weeks (T1), and 4 weeks (T2).
A quantitative measure of upper limb motor recovery. The scale includes 33 items assessing reflexes, movement patterns, and coordination. Scores range from 0 to 66, with higher scores indicating better motor function.
5 secondary outcomes
Brunnstrom Recovery Stage (Upper Limb)
Time frame: Baseline (T0), 2 weeks (T1), and 4 weeks (T2).
Kinesthetic and Visual Imagery Questionnaire (KVIQ-10)
Time frame: Baseline (T0), 2 weeks (T1), and 4 weeks (T2).
Laterality Judgment Task (LJT) - Accuracy and Reaction Time
Time frame: Baseline (T0), 2 weeks (T1), and 4 weeks (T2).
Sense of Agency (SoA) Questionnaire
Time frame: Baseline (T0), 2 weeks (T1), and 4 weeks (T2).
System Usability Scale (SUS)
Time frame: 4 weeks (T2).
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 12 Feb 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing single-joint robot (Passive Mode) in people with To Understand Whether Increasing the Willingness to Exercise Can Improve Rehabilitation Outcomes (Upper Limb Motor Activation) and for Patient With Stroke, run by Taipei Hospital, Ministry of Health and Welfare.
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 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: opening soon, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Fugl-Meyer Assessment - Upper Extremity (FMA-UE) (time frame: Baseline (T0), 2 weeks (T1), and 4 weeks (T2).). 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 12 Feb 2026.