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The key technology development of a multimodal intelligent hand rehabilitation robot based on central-peripheral closed-loop regulation Study 2: The therapeutic effect of sequential treatment combining rTMS and soft robotic hand rehabilitation on hand function recovery in stroke patients

The key technology development of a multimodal intelligent hand rehabilitation robot based on central-peripheral closed-loop regulation Study 2: The therapeutic effect of sequential treatment combining rTMS and soft robotic hand rehabilitation on hand function recovery in stroke patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097290
Enrollment
Unknown
Registered
2025-02-17
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-02-24

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

Conditions

"Cerebrovascular Disease"

Interventions

Experimental Group A:rTMS (10 Hz) was applied to the affected M1 area for 20 minutes, followed by 20 minutes of soft robotic glove training, for a total of 40 minutes.The treatment was conducted once
Experimental Group B:rTMS (10 Hz) was applied to the affected M1 area for 5 minutes, followed by 5 minutes of soft robotic training. This was repeated 4 times, for a total of 40 minutes. The treatment
Experimental Group C:The rTMS intervention was applied using a sham stimulation coil, with all other stimulation parameters consistent with those of experimental group A. All patients received convent

Sponsors

Zhongda Hospital, Affiliated to Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with cerebral infarction by CT scan and/or MRI; 2. First episode, unilateral onset, or previous episodes without residual neurological deficits; 3. Stable vital signs and clear consciousness; 4. Age between 40 and 70 years; 5. Disease duration of 1 week to 3 months; 6. Hand function at Brunnstrom stages 1 to 3; 7. No cognitive dysfunction; 8. Informed consent signed by the participant or their family members.

Exclusion criteria

Exclusion criteria: 1. History of epilepsy, history of idiopathic epilepsy in first-degree relatives, or use of proconvulsant medications; 2. Severe cognitive or communication impairments that prevent cooperation with assessment and treatment; 3. Posterior circulation cerebral infarction; 4. Presence of a pacemaker or metallic implants in the skull; 5. Severe cervical spine pathology, including severe cervical spinal stenosis or cervical spine instability; 6. Complete occlusion of the internal carotid artery; 7. Direct damage to the stimulation area or skull defects; 8. Pregnant women.

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer(FMA-UE);

Secondary

MeasureTime frame
Hong Kong Version of the Upper Limb Function Test for Hemiplegia.; Modified Ashworth Scale (MAS);International Classification of Functioning, Disability and Health - Upper Limb Function;

Countries

China

Contacts

Public ContactWenli Chen

Southeast University Affiliated Zhongda Hospital

banlilizhi@163.com+86 139 5161 6588

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026