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Efficacy and neural mechanisms of a soft robotic glove based on brain-computer interface on hand function in stroke patients

Efficacy and neural mechanisms of a soft robotic glove based on brain-computer interface on hand function in stroke patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082786
Enrollment
Unknown
Registered
2024-04-08
Start date
2024-04-22
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Stroke

Interventions

Experimental group:Soft robotic glove based on brain-computer interface
Control group:Soft robotic glove

Sponsors

Wuxi Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Diagnosis of stroke according to the 10th edition of the International Classification of Diseases (ICD); 2) First-time, unilateral onset or previous seizures without residual neurological deficits; 3) Stable vital signs and clear consciousness; 4) Age: 30-80 years old; 5) Site of lesion: right hemispheric subcortical injury; duration of disease: within 2 weeks-3 months; 6) Persistent hemiparesis resulting in hand dysfunction, Brunnstrom's hand II-IV, and the rest of motor function to any of the following: a. Partial functional movement of the upper limb with an ARAT "Gross Movement" score of =3; b. Presence of partial active movement of the upper extremities.Manual muscle test (MMT) score =2 on shoulder flexion and elbow flexion or extension. c. Removal of gravity with at least 50% active range of shoulder flexion or abduction and any of the following active activities: elbow flexion, elbow extension, wrist flexion, wrist extension; 7) Near normal passive mobility of all joints of the upper extremity on the hemiplegic side; 8) MMSE(Mini-Mental State Examination) score>20; The participant can understand and cooperate with the assessment and training; 9) The enrollee himself/herself or his/her family signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Combined peripheral nerve injury, Parkinson's, multiple sclerosis, and other neurologic disorders; 2) Decreased or failed function of vital organs such as heart, lungs, liver and kidneys; 3) Patients with cognitive impairment, aphasia, etc. who are unable to understand the therapist's instructions; 4) Posterior circulation infarction; 5) Severe spasticity of the upper extremities (Modified Ashworth Scale = 3) or contractures of the wrist-hand joints; 6) Having severe cervical spine pathology including severe cervical stenosis and cervical instability; 7) Complete occlusion of the internal carotid artery on the side of cerebral infarction; 8) Skin injury, infection, pain sensitization; 9) Women during pregnancy.

Design outcomes

Primary

MeasureTime frame
Action Research Arm Test;

Secondary

MeasureTime frame
ICF core set hand function part;Fugl-Meyer Assessment Upper Extremity Scale, FMA-UE;Motricity Index, MI;Modified Barthel Index, MBI;Functional near - infrared spectroscopy, fNIRS;

Countries

China

Contacts

Public ContactJi Xiang

Wuxi Mental Health Center/Wuxi Central Rehabilitation Hospital

522927214@qq.com+86 188 6154 5024

Outcome results

None listed

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