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Post-stroke Upper Limb HemiparesisNCT07054424

Repetitive Transcranial Magnetic Stimulation Combined With Bimanual Therapy for Upper Limb Stroke Rehabilitation

A study testing Conventional occupation therapy, stretching exercise and rTMS in people with Post-stroke Upper Limb Hemiparesis and Repetitive Transcranial Magnetic Stimulation (rTMS), 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
Search all trials

Trial summary

The goal of this clinical trial is to evaluate whether combining repetitive transcranial magnetic stimulation (rTMS) with machine-assisted bimanual therapy (BT) can improve upper limb function in stroke patients. Read more about this study

Who is it for?
Ages 40 to 80 years
What is being tested?
Conventional occupation therapy, stretching exercise and rTMS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
1 siteTaiwan
Study dates
5 Jun 2025to 31 Jul 2027
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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 40-80 years;
  • First-onset stroke patients;
  • Patients diagnosed with cerebral infarction or hemorrhage through CT or MRI;
  • Signed informed consent form by the patient and their family;
  • Stable physiological parameters;
  • Stroke occurred within the last 12 months;
Show all 9Show fewer
  • Patients with unilateral hand function impairment caused by the stroke;
  • Upper limb muscle tone (Modified Ashworth Scale, MAS) less than 3 points;
  • Able to follow two-step commands.

Who cannot join

  • A history of epilepsy or family history of epilepsy;
  • Presence of suicidal tendencies;
  • Currently using medications that lower the seizure threshold;
  • Pregnant or planning to become pregnant;
  • Co-existing neurological diseases (such as multiple sclerosis, other neurodegenerative diseases, meningitis, brain abscess, or meningioma);
  • Subjects with uncontrollable migraines caused by elevated intracranial pressure;
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  • Subjects taking antidepressants who cannot discontinue the medication;
  • Subjects with sleep disorders during rTMS treatment;
  • Subjects with cerebellar stroke or brainstem stroke;
  • Cerebral ischemic disorders resulting from traumatic brain injury;
  • Transient ischemic attacks (TIAs);
  • History of bleeding tendency and other conditions affecting upper limb function, such as myasthenia gravis, systemic immune neuropathy, severe epilepsy, endocrine system disorders, wearers of external or internal cardiac pacemakers, individuals with metallic implants or orthopedic devices;
  • Co-existing severe heart, liver, kidney dysfunction, or other serious physical illnesses;
  • Subjects with impaired consciousness who cannot cooperate with examinations or treatments, such as those with mental disorders, or those with intellectual or cognitive impairments, severe dementia;
  • Presence of implanted electronic devices in the body;
  • Co-existing severe liver, kidney, or hematological disorders;
  • Special vulnerable populations;
  • Skin disease (e.g., pressure ulcers, trauma, cellulitis, etc.).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yu-Cheng Pei, MD, PhD contact

+886 3 3281200 ext. 3846

yspeii@gmail.com

Taiwan1 site, 1 recruiting
  • Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital at Linkou, Taoyuan 333, Taiwan

    Taoyuan

    Yu-Cheng Pei, MD, PhD, +886 3 3281200 ext. 3846, yspeii@gmail.com

    Recruiting

Other trials in Taiwan

About this study

Official title: Development of Repetitive Transcranial Magnetic Stimulation (rTMS) Combined With Machine-assisted Bimanual Therapy (BT) in Upper Limb Rehabilitation

The goal of this clinical trial is to evaluate whether combining repetitive transcranial magnetic stimulation (rTMS) with machine-assisted bimanual therapy (BT) can improve upper limb function in stroke patients. The participants will be individuals aged 40-80 years who have experienced a first-time ischemic or hemorrhagic stroke. The main questions it aims to answer are:

  • Does the combined therapy enhance motor recovery compared to traditional rehabilitation methods?
  • Are changes in brain activity associated with improvements in upper limb function?
Read more

Participants will be randomly assigned to different groups and will:

  • Receive rTMS stimulation on specific areas of the brain to modulate neural activity,
  • Perform machine-assisted bimanual exercises to promote motor skills, and
  • Undergo assessments before, immediately after, and during follow-up periods to measure functional improvements.
Being tested
Conventional occupation therapy, stretching exercise, rTMS, bimanual therapy
Keywords
Stroke, neurorehabilitation, rTMS, bimanual therapy, neuromodulation, upper limb function, theta burst stimulation, brain plasticity
Medical subject headings
Stroke

What participants receive

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

  • Conventional occupation therapyOther

    Standard occupational therapy focused on improving daily functional skills through task-specific training and adaptive techniques.

  • stretching exerciseOther

    Techniques involving passive or active stretching of muscles to enhance flexibility, reduce spasticity, and prevent contractures.

  • rTMSOther

    Non-invasive brain stimulation method using magnetic pulses to modulate cortical excitability and promote neural plasticity.

  • bimanual therapyDevice

    A training approach that involves simultaneous use of both hands to enhance coordination and functional hand movements through guided exercises, including device-assisted and robot-assisted therapy

Study groups in NCT07054424
Study groupRoleWhat they receive
Control groupSham comparator15 mins self-initiated stretching exercise + 50 mins conventional occupational therapy
Receives: Other: Conventional occupation therapy; Other: stretching exercise
rTMS-only groupActive comparator15 mins rTMS and 50 mins conventional occupational therapy
Receives: Other: Conventional occupation therapy; Other: rTMS
rTMS combined with bimanual therapy groupExperimental15 mins therapy (rTMS + bimanual therapy) and 50 mins conventional occupational therapy
Receives: Other: Conventional occupation therapy; Other: rTMS; Device: bimanual therapy

What is being measured

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

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

    This assessment captures motor recovery across four specific domains: Part A (proximal upper limb-shoulder, elbow, and forearm), Part B (wrist), Part C (hand), and Part D (coordination and speed). The full scale ranges from 0 to 66 and the higher scores represent the better outcome.

    Measured: Evaluated at before and after (immediately following the final sessions) the intervention. Additionally, follow-up assessments are conducted at 1 month and 3 months post-treatment to evaluate sustained effects.

Secondary outcomes (7)
  1. Modified Ashworth Scale (MAS)

    This scale is used to evaluate spasticity in muscles by assessing resistance during passive soft-tissue stretching. Scores range from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension), with higher scores indicating greater spasticity.

    Measured: Evaluated at before and after (immediately following the final sessions) the intervention. Additionally, follow-up assessments are conducted at 1 month and 3 months post-treatment to evaluate sustained effects.

  2. Upper Extremities Muscle Strength

    Manual muscle testing (MMT) is used to assess the strength of major upper limb muscle groups, including the shoulder abductors, elbow flexors/extensors, wrist extensors, and finger flexors/extensors. The scoring is based on the standard 0-5 MMT grading scale, where higher scores indicate greater muscle strength.

    Measured: Evaluated at before and after (immediately following the final sessions) the intervention. Additionally, follow-up assessments are conducted at 1 month and 3 months post-treatment to evaluate sustained effects.

  3. Action Reach Arm Test (ARAT)

    The ARAT is a standardized observational assessment that evaluates upper limb function through 19 items across four domains: grasp, grip, pinch, and gross movement. The total score ranges from 0 to 57, with higher scores indicating better upper extremity function.

    Measured: Evaluated at before and after (immediately following the final sessions) the intervention. Additionally, follow-up assessments are conducted at 1 month and 3 months post-treatment to evaluate sustained effects.

  4. Brunnstrom Recovery Stage

    This classification system assesses motor recovery following stroke and categorizes the patient's progress into six stages for the upper extremity, hand, and lower extremity. Stage I represents flaccidity, and Stage VI represents near-normal movement.

    Measured: Evaluated at before and after (immediately following the final sessions) the intervention. Additionally, follow-up assessments are conducted at 1 month and 3 months post-treatment to evaluate sustained effects.

  5. Instrumental Activities of Daily Living Scale (IADLs)

    The IADLs assess functional independence in more complex daily tasks, including using the telephone, shopping, food preparation, housekeeping, laundry, mode of transportation, responsibility for own medications, and ability to handle finances. The scores vary by gender: for females, the full 8 items are scored (0-8); for males, traditional scoring omits food preparation, housekeeping, and laundry, resulting in a 5-point scale (0-5). Higher scores indicate greater functional independence.

    Measured: Evaluated at before and after (immediately following the final sessions) the intervention. Additionally, follow-up assessments are conducted at 1 month and 3 months post-treatment to evaluate sustained effects.

  6. System Usability Scale (SUS)

    The usability of the device and intervention was evaluated using the System Usability Scale (SUS), which captures user experience from both patients and caregivers. The SUS comprises ten Likert-scale items, alternating between positive and negative statements to minimize response bias. Each item is rated from 1 (strongly disagree) to 5 (strongly agree). The total SUS score is calculated and converted to a scale of 0 to 100, with scores above 68 generally indicating acceptable usability.

    Measured: Administered once immediately after the final intervention session to capture the participant's impressions of the device's usability.

  7. Satisfaction Questionnaire

    A custom satisfaction questionnaire was administered to evaluate participants' overall satisfaction with the rehabilitation process. It uses a 5-point Likert-type scale ranging from 1 (very poor) to 5 (very good) to assess domains such as comfort, perceived effectiveness, motivation, and willingness to continue. Higher scores reflect more favorable responses and higher levels of satisfaction.

    Measured: Administered once immediately after the final intervention session to assess participants' subjective satisfaction with the intervention.

Timeline

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

  1. First posted8 Jul 2025
  2. Study start5 Jun 2025
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jul 2027 (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
Model description
An investigator reviewed the inclusion and exclusion criteria and assigned participants to one of the study groups. Participants were randomly allocated to either the rTMS combined with bimanual therapy group, the rTMS only group, or the control group receiving standard rehabilitation. Randomization and group assignment were performed by a research assistant using a computer-generated randomization sequence to ensure unbiased allocation. Each intervention was conducted over a 4-week period, consisting of 10 sessions, during which participants received intervention according to their assigned group.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07054424
Sponsor's protocol ID
202400379A0C6001
Status last verified
Jun 2026
First submitted
8 Jun 2025
Last updated
11 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Kim WS, Paik NJ. Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. Brain Neurorehabil. 2021 Mar 18;14(1):e6. doi: 10.12786/bn.2021.14.e6. eCollection 2021 Mar.

    PubMed 36742107
  • Oberman L, Edwards D, Eldaief M, Pascual-Leone A. Safety of theta burst transcranial magnetic stimulation: a systematic review of the literature. J Clin Neurophysiol. 2011 Feb;28(1):67-74. doi: 10.1097/WNP.0b013e318205135f.

    PubMed 21221011
  • Liu C, Li L, Li B, Liu Z, Xing W, Zhu K, Jin W, Lin S, Tan W, Ren L, Zhang Q. Efficacy and Safety of Theta Burst Versus Repetitive Transcranial Magnetic Stimulation for the Treatment of Depression: A Meta-Analysis of Randomized Controlled Trials. Neuromodulation. 2024 Jun;27(4):701-710. doi: 10.1016/j.neurom.2023.08.009. Epub 2023 Oct 12.

    PubMed 37831019
  • Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033.

    PubMed 15664172
  • Li X, Lin YL, Cunningham DA, Wolf SL, Sakaie K, Conforto AB, Machado AG, Mohan A, O'Laughlin K, Wang X, Widina M, Plow EB. Repetitive Transcranial Magnetic Stimulation of the Contralesional Dorsal Premotor Cortex for Upper Extremity Motor Improvement in Severe Stroke: Study Protocol for a Pilot Randomized Clinical Trial. Cerebrovasc Dis. 2022;51(5):557-564. doi: 10.1159/000521514. Epub 2022 Jan 20.

    PubMed 35051941
  • Chen YM, Lai SS, Pei YC, Hsieh CJ, Chang WH. Development of a Novel Task-oriented Rehabilitation Program using a Bimanual Exoskeleton Robotic Hand. J Vis Exp. 2020 May 20;(159). doi: 10.3791/61057.

    PubMed 32510515
  • Huang JJ, Pei YC, Chen YY, Tseng SS, Hung JW. Bilateral Sensorimotor Cortical Communication Modulated by Multiple Hand Training in Stroke Participants: A Single Training Session Pilot Study. Bioengineering (Basel). 2022 Nov 24;9(12):727. doi: 10.3390/bioengineering9120727.

    PubMed 36550934
  • Chen JL, Ros T, Gruzelier JH. Dynamic changes of ICA-derived EEG functional connectivity in the resting state. Hum Brain Mapp. 2013 Apr;34(4):852-68. doi: 10.1002/hbm.21475. Epub 2012 Feb 17.

    PubMed 22344782
  • Lyle RC. A performance test for assessment of upper limb function in physical rehabilitation treatment and research. Int J Rehabil Res. 1981;4(4):483-92. doi: 10.1097/00004356-198112000-00001. No abstract available.

    PubMed 7333761
  • De Weerdt WJG, Harrison MA. "Measuring recovery of arm-hand function in stroke patients: a comparison of the Brunnstrom-Fugl-Meyer test and the Action Research Arm test. Physiotherapy Canada. 1985; 37:65-70.

  • Crow JL, Lincoln NB, Nouri FM, De Weerdt W. The effectiveness of EMG biofeedback in the treatment of arm function after stroke. Int Disabil Stud. 1989 Oct-Dec;11(4):155-60. doi: 10.3109/03790798909166667.

    PubMed 2701823
  • CARROLL D. A QUANTITATIVE TEST OF UPPER EXTREMITY FUNCTION. J Chronic Dis. 1965 May;18:479-91. doi: 10.1016/0021-9681(65)90030-5. No abstract available.

    PubMed 14293031
  • Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985 Jun;39(6):386-91. doi: 10.5014/ajot.39.6.386.

    PubMed 3160243
  • Fugl-Meyer AR. Post-stroke hemiplegia assessment of physical properties. Scand J Rehabil Med Suppl. 1980;7:85-93. No abstract available.

    PubMed 6932734
  • Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.

    PubMed 1135616

Questions about this trial

What is this clinical trial studying?

A study testing Conventional occupation therapy, stretching exercise and rTMS in people with Post-stroke Upper Limb Hemiparesis and Repetitive Transcranial Magnetic Stimulation (rTMS), 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 9 inclusion and 18 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 11 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. Some participants in this study may receive a placebo. 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-Cheng Pei, MD, PhD (+886 3 3281200 ext. 3846, yspeii@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fugl-Meyer Assessment for Upper Extremity (FMA-UE) (time frame: Evaluated at before and after (immediately following the final sessions) the intervention. Additionally, follow-up assessments are conducted at 1 month and 3 months post-treatment to evaluate sustained effects.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07054424, which also lists 15 linked publications.

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 11 Jun 2026.

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