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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorChang Gung Memorial Hospital

About this trial

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?

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conventional occupation therapy

    Other intervention

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

  • stretching exercise

    Other intervention

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

  • rTMS

    Other intervention

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

  • bimanual therapy

    Device

    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

Treatment groups

54 Participants
are divided into 3 treatment groups
Group A: Control groupSham comparator 2 interventions
Group B: rTMS-only groupActive comparator 2 interventions
Group C: rTMS combined with bimanual therapy groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

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.

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.

Secondary outcomes

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.

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.
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.

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.
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.

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.
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.

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.

Other outcomes

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