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Stroke PatientsNCT06258538

Effects of Circuit Training Combining Different Types of Distal Robot-assisted and Task-oriented Therapy on Motor Control, Motor and Daily Functions, and Quality of Life After Stroke

A study testing Robots can aid in distal UE rehabilitation through exoskeleton (EXO), End-effector robot-assisted therapy (EE) and Unilateral task-oriented therapy in people with Stroke Patients, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study proposes a novel stroke rehabilitation approach for upper extremity training by firstly combining different types of distal robot-assisted and task-oriented therapy in a circuit training program. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Stroke Patients
What is being tested?
Robots can aid in distal UE rehabilitation through exoskeleton (EXO), End-effector robot-assisted therapy (EE) and Unilateral task-oriented therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
1 siteTaiwan
Study dates
1 Jun 2024to 31 Dec 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • unilateral stroke ≥ 3 months onset
  • Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score between 18 to 56, indicating different levels of motor impairments ;
  • without excessive spasticity in any of the UE joint (modified Ashworth scale ≤3 in proximal joints and modified Ashworth scale ≤2 in distal joints);
  • Mini Mental State Exam (MMSE) score > 24, indicating no serious cognitive impairment;
  • between the ages of 20 and 75 years -

Who cannot join

  • histories of other neurological diseases such as dementia, Parkinson's disease, and peripheral polyneuropathy;
  • difficulties in following and understanding instructions such as global aphasia;
  • enroll in other rehabilitation or drug studies simultaneously;
  • receiving Botulinum toxin injections within 3 months. -

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
  • Chang Gung Memotial Hospital

    Taoyuan, Taoyuan, 3333

    Yu-Wei Hsieh, ScD, +886-3-2118800 ext. 3820, ywhlab.ra@gmail.com

    Recruiting

Other trials in Taiwan

About this study

This study proposes a novel stroke rehabilitation approach for upper extremity training by firstly combining different types of distal robot-assisted and task-oriented therapy in a circuit training program. The program could enhance UE functions, improving daily function, decrease caregiver burden and lower medical expenses associated with long-term care. Professionals can use these findings to promote the application of clinically empirical research and better understand the effects and mechanisms of circuit training.

Conditions
Stroke Patients
Being tested
Robots can aid in distal UE rehabilitation through exoskeleton (EXO), End-effector robot-assisted therapy (EE), Unilateral task-oriented therapy, Bilateral task-oriented therapy
Keywords
Stroke rehabilitation, distal upper extremity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robots can aid in distal UE rehabilitation through exoskeleton (EXO)Device

    Exoskeleton robot-assisted therapy Each EXO robot-assisted therapy session consists of continuous passive motion (30 percent of duration), active-assisted training (30 percent of duration), and interactive training (40 percent of duration) using the Hand of Hope (HOH) robotic hand system . HOH is an exoskeleton type of robot that is worn on the dorsal side of the impaired hand with 2 surface EMG sensors attached to the extensor digitorum and flexor digitorum superficialis.

  • End-effector robot-assisted therapy (EE)Device

    Each EE robot-assisted therapy session consists of continuous passive motion (30 percent of duration), active-assisted training (30 percent of duration), and interactive training (40 percent of duration) using the Amadeo robotic system. Amadeo is an end-effector robot with 5 finger slides, which are attached to the fingertips and the thumb via magnetic finger pads. The integrated sensor for each finger allows the robot system to provide patients with real-time visual feedback of finger strengths and range of motion

  • Unilateral task-oriented therapyBehavioural

    The therapy will focus on task-oriented therapy with the affected UE and the training tasks involve proximal or distal UE movement, such as ringing a bell, picking up coins, grasping and releasing various cups, and other functional movements involved in daily activities. The level of challenge will be adapted according to patient ability and improvement during training.

  • Bilateral task-oriented therapyBehavioural

    The functional training tasks emphasize UE movements (gross or fine motor tasks) involved in daily activities but focus on both UEs moving synchronously, such as opening 2 closet doors, grasping and releasing 2 towels, wiping the table with 2 hands, and so on. The activities can also be graded in terms of difficulty and task requirements, according to the impairment level and the progression of the UE of each participant.

Study groups in NCT06258538
Study groupRoleWhat they receive
distal robot-assisted and task-oriented therapyExperimentalParticipants in the Circuit group received interventions for 20-min exoskeleton(EXO) and 20-min end-effector(EE) robot-assisted therapy, followed by 20-min uni- and 20-min bi- task-oriented therapy/session, 3 sessions/week for 6 consecutive weeks.
Receives: Device: Robots can aid in distal UE rehabilitation through exoskeleton (EXO); Device: End-effector robot-assisted therapy (EE); Behavioral: Unilateral task-oriented therapy; Behavioral: Bilateral task-oriented therapy
distal robot-assisted therapy aloneExperimentalParticipants in the Robot group received interventions for 40-min exoskeleton(EXO) and 40-min end-effector(EE) robot-assisted therapy/session, 3 sessions/week for 6 consecutive weeks.
Receives: Device: Robots can aid in distal UE rehabilitation through exoskeleton (EXO); Device: End-effector robot-assisted therapy (EE)
task-oriented therapy aloneActive comparatorParticipants in the task-oriented therapy(TOT) group received interventions for 40-min uni- and 40-min bi- task-oriented therapy/session, 3 sessions/week for 6 consecutive weeks.
Receives: Behavioral: Unilateral task-oriented therapy; Behavioral: Bilateral task-oriented therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mini-Mental State Examination (MMSE)

    The MMSE is a 30-point questionnaire that is the most commonly used brief screening tool for detecting cognitive impairment. Higher values represent better cognitive functioning. The MMSE has good psychometric properties for identifying cognitive impairment

    Measured: baseline , after the completion of the 18-session intervention , and 3 month after intervention

  2. Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

    The upper-extremity subscale of FMA will be used to assess sensorimotor impairment. The FMA-UE includes 33 items assessing movements, reflexes, and coordination of upper limbs. Each item is measured on a 3-point ordinal scale and the total score ranges from 0 to 66 . A higher score indicates better motor function.

    The reliability and validity of the Fugl-Meyer Assessment are well established

    Measured: baseline , after the completion of the 18-session intervention , and 3 month after intervention

  3. Modified Ashworth scale of muscle spasticity (MAS)

    The MAS is a 6-point ordinal scale assessing muscle tone, where higher scores represent spasticity. The MAS scores of proximal and distal arm muscles will be examined. The MAS has good validity and reliability

    Measured: baseline , after the completion of the 18-session intervention , and 3 month after intervention

  4. Grip and pinch strength

    The Jamar dynamometer is a standard, accurate, adjustable-handle tool specifically for measuring grip and pinch strength .

    Participants are asked to perform tasks under unilateral and bilateral conditions. In the unilateral condition, participants are asked to exert only with their paretic hands; in the bilateral condition, participants are asked to exert with both hands. Three trials will be taken at each assessment, and the average of three trials will be documented.

    Measured: baseline , after the completion of the 18-session intervention , and 3 month after intervention

  5. Medical Research Council scale (MRC)

    The MRC is an ordinal scale assessing muscle strength. The scoring for each muscle ranges from 0 to 5, with a higher score indicates greater muscle strength. The reliability of MRC was good to excellent in stroke patients

    Measured: baseline , after the completion of the 18-session intervention , and 3 month after intervention

  6. Revised Nottingham Sensory Assessment (rNSA)

    The rNSA will be used to evaluate changes in sensation. It equips with various sensory modalities to assess tactile sensation, proprioception, and stereognosis of different segments of the body . Scoring of rNSA is based on a 3-point ordinal scale (0-2), with a lower score suggesting greater sensory impairment. The psychometric properties have been established in stroke patients

    Measured: baseline , after the completion of the 18-session intervention , and 3 month after intervention

  7. Wolf Motor Function Test (WMFT)

    The WMFT assesses upper extremity motor ability by measuring the performance time (WMFT-Time) and functional ability rating scale (WMFT-FAS) in required task. Participants were timed and rated by using a 6-point ordinal scale. The WMFT is valid and reliable on assessing motor function in stroke patients

    Measured: baseline , after the completion of the 18-session intervention , and 3 month after intervention

  8. Motor Activity Log (MAL)

    The MAL falls within the activity and participation domains of ICF framework. It is a semi-structured interview for stroke patients to assess the amount of use (MAL-AOU) and quality of movement (MAL-QOM) of their affected arm and hand during 30 activities of daily living. The score of each activity ranges from 0 to 5, and higher scores represent more frequently used or higher quality of movement. The MAL has good validity, reliability, and responsiveness in patients with stroke

    Measured: baseline , after the completion of the 18-session intervention , and 3 month after intervention

  9. Nottingham Extended Activities of Daily Living Scale (NEADL):

    The NEADL is a measure of independence in 4 areas of daily life, including mobility, kitchen, domestic, and leisure activities. It includes 22 items, and each item is measured on a 4-point scale. The total score ranges from 0 to 66 and a higher score indicates better daily functional ability. The psychometric properties of the NEADL have been well established.

    Measured: baseline , after the completion of the 18-session intervention , and 3 month after intervention

  10. Stroke Impact Scale Version 3.0 (SIS 3.0)

    The SIS 3.0 is a stroke-specific health-related quality of life instrument. It consists of 59 items grouped into 8 domains (strength, hand function, ADL/instrumental ADL, mobility, communication, emotion, memory and thinking, and participation/role function). The participants will be asked to rate each item on a 5-point Likert scale for the perceived difficulty in completing the task. An extra question will be asked to evaluate the participant's self-perceived overall recovery from stroke. The SIS 3.0 has satisfactory psychometric properties in stroke patients

    Measured: baseline , after the completion of the 18-session intervention , and 3 month after intervention

  11. The stroke self-efficacy questionnaires (SSEQ):

    The SSEQ measures an individual's confidence in relation to functional performance and self-management after stroke. It includes 13 items, and each item is rated on a 10-point scale from 0 (not at all confident) to 10 (very confident). The reliability and validity of the SSEQ are well established

    Measured: baseline , after the completion of the 18-session intervention , and 3 month after intervention

  12. Daily Living Self-Efficacy Scale (DLSES):

    The DLSES measures self-efficacy of daily functioning, including psychosocial functioning and activities of daily living. The scale consists of 12 items, and each item is measured on a 100-point scale with 10-unit intervals (0 = cannot do at all, 100 = highly certain can do). A higher score indicates a higher level of self-efficacy. The DLSES is a psychometrically sound measure of self-efficacy in stroke survivors

    Measured: baseline , after the completion of the 18-session intervention , and 3 month after intervention

  13. Functional Abilities Confidence Scale (FACS):

    The FACS measures the degree of selfefficacy and confidence when the participants perform various movements and postures. It consists of 15 questions scoring from 0% (not confidence at all) to 100% (fully confidence). A higher score indicates higher confidence in performing the movements. The psychometric properties are good

    Measured: baseline , after the completion of the 18-session intervention , and 3 month after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2024
  2. Study start1 Jun 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Participant
Enrolment
87 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06258538
Sponsor's protocol ID
202301367B0
Status last verified
Mar 2026
First submitted
6 Feb 2024
Last updated
20 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Robots can aid in distal UE rehabilitation through exoskeleton (EXO), End-effector robot-assisted therapy (EE) and Unilateral task-oriented therapy in people with Stroke Patients, 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 5 inclusion and 4 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 20 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 Yu-Wei Hsieh, ScD (Phone: #886 886-3-2118800 ext. 3820, ywhlab.ra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mini-Mental State Examination (MMSE) (time frame: baseline , after the completion of the 18-session intervention , and 3 month after intervention). The study lists 13 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 20 Mar 2026.

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