Robotic hand-assisted Transcranial Magnetic Stimulation therapy for rehabilitation from brain damage caused by stroke

Comparison of clinical outcomes of robotic hand exoskeleton assisted Transcranial Magnetic Stimulation therapy with dose-matched conventional upper limb rehabilitation: A Randomized Clinical Trial on patients with stroke

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN95291802

Enrollment

Registered

2020-10-23

Start date

2015-10-01

Completion date

Unknown

Last updated

2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Evaluation of clinical outcomes in response to the robotic hand-assisted Transcranial Magnetic Stimulation (TMS) therapy in patients with stroke Nervous System Diseases

Interventions

Patients with stroke are randomly divided into 4 groups: 1. Comparator Agent: Physiotherapy - Patient will be asked to do clinical physiotherapy as prescribed by the therapist 2. Intervention: Robotic

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.18 - 70 years of age 2. Single lesioned, Chronic (3 months - 24 months) stroke 3. Cortical/sub-cortical, Ischemic/Hemorrhagic stroke, 4. Modified Ashworth Scale (1,1+, 2), Brunnstrom stage (3-5), Medical Research Council Scale (2-4), 5. Should have motor cortex MEP >= 10uv in lesion hemisphere, 6. Should have wrist extension EMG activity, 7. Is able to give informed consent 8. Can follow the instruction to execute training task with Mini-Mental Scale (MMS 24 - 30)

Exclusion criteria

Exclusion criteria: 1. Contra-indications to TMS 2. Progressive neurological or cognitive disorders impinging with assessment scales

Design outcomes

Primary

Measure	Time frame
At baseline and 4 weeks: 1. Spasticity of wrist joint measured using the Modified Ashworth Scale (MAS) 2. Sequence of stages of recovery post-stroke measured using the Brunnstrom stage (BS) 3. Functional independence of patient in Activity of Daily Living (ADL) measured using the Barthel Index 4. Performance-based sensorimotor function index of whole arm measured using Fugl-Meyer Assessment (FMA) 5. Wrist-joint movement without assistance measured through Active Range of Motion on scale: 0 to 70 degrees 6. Disability measurement using the Modified Rankin Scale 7. Patient experience with the therapy sessions using self-designed subjective questionnaire feedback in terms of use, functionality, ease of use, potential of home-based use, user-friendly etc. 8. User-feedback on the usability, complexity and ease of use measured using an industry based System Usability Scale	—

Measure

Time frame

At baseline and 4 weeks: 1. Spasticity of wrist joint measured using the Modified Ashworth Scale (MAS) 2. Sequence of stages of recovery post-stroke measured using the Brunnstrom stage (BS) 3. Functional independence of patient in Activity of Daily Living (ADL) measured using the Barthel Index 4. Performance-based sensorimotor function index of whole arm measured using Fugl-Meyer Assessment (FMA) 5. Wrist-joint movement without assistance measured through Active Range of Motion on scale: 0 to 70 degrees 6. Disability measurement using the Modified Rankin Scale 7. Patient experience with the therapy sessions using self-designed subjective questionnaire feedback in terms of use, functionality, ease of use, potential of home-based use, user-friendly etc. 8. User-feedback on the usability, complexity and ease of use measured using an industry based System Usability Scale

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Secondary

Measure	Time frame
At baseline and 4 weeks: 1. Cortical Excitability measurements: 1.1. Peak to peak amplitude (in microvolts) of Motor Evoked Potential (MEP) response of cortex measured using Transcranial Magnetic Stimulation 1.2. Resting Motor Threshold Intensity (in %) to generate the MEP measured using Transcranial Magnetic Stimulation 1.3. Latency period of MEP (in milliseconds), measured using Transcranial Magnetic Stimulation 2. Functional Magnetic Resonance Imaging measures: 2.1. Number of active voxels in different regions of brain while performing the wrist extension task, measuring neuronal activity 2.2. Volume of activation of brain while performing the wrist extension task, measuring neuronal activity 2.3. Structural MRI, measuring any structural changes in brain	—

Measure

Time frame

At baseline and 4 weeks: 1. Cortical Excitability measurements: 1.1. Peak to peak amplitude (in microvolts) of Motor Evoked Potential (MEP) response of cortex measured using Transcranial Magnetic Stimulation 1.2. Resting Motor Threshold Intensity (in %) to generate the MEP measured using Transcranial Magnetic Stimulation 1.3. Latency period of MEP (in milliseconds), measured using Transcranial Magnetic Stimulation 2. Functional Magnetic Resonance Imaging measures: 2.1. Number of active voxels in different regions of brain while performing the wrist extension task, measuring neuronal activity 2.2. Volume of activation of brain while performing the wrist extension task, measuring neuronal activity 2.3. Structural MRI, measuring any structural changes in brain

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Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 23, 2026