stroke
Conditions
Interventions
Conventional Rehabilitation Group (Positive Control Group):Participants in this group will receive conventional rehabilitation, including standard occupational therapy, serving as the reference treatm
Soft Exoskeleton + FES Group (Non-BCI Group):In addition to conventional rehabilitation, participants in this group will receive passive soft exoskeleton–assisted training combined with functional ele
BCI-Controlled Soft Exoskeleton + FES Group(Intervention Group):Based on conventional rehabilitation, participants in this group will receive motor imagery–based BCI–controlled soft exoskeleton traini
Sponsors
China Rehabilitation Research Center
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of stroke in accordance with the Diagnostic Criteria for Major Types of Cerebrovascular Diseases in China (2019), confirmed by CT or MRI; first-ever stroke with a disease duration of 1–3 months. 2. Aged 18–65 years, with no restriction on sex. 3. Right-sided hemiplegia, with the affected hand at Brunnstrom stage I–II, indicating moderate to severe motor impairment. 4. Mini-Mental State Examination (MMSE) score > 21, applicable to non-illiterate participants. 5. The patient or their legal guardian has provided written informed consent. 6. Kinesthetic and Visual Imagery Questionnaire (KVIQ-20) score >= 55
Exclusion criteria
Exclusion criteria: 1. Presence of dementia (MMSE score = 17 for illiterate participants), or severe hearing, visual, or speech impairments that prevent cooperation with training procedures. 2. Musculoskeletal or neurological conditions affecting the affected upper limb, such as fractures, severe arthritis, joint replacement, or other disorders that interfere with motor function. 3. A confirmed medical history of cognitive impairment caused by neurological diseases, such as Alzheimer’s disease or Parkinson’s disease. 4. Presence of contraindications to brain–computer interface (BCI), soft exoskeleton, functional electrical stimulation (FES), or functional near-infrared spectroscopy (fNIRS). 5. Intracranial metallic implants, metallic pacemakers, or incomplete cranial integrity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fugl-Meyer Upper Limb Motor Function Assessment Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Action ResearchArm Test, ARAT;modified Ashworth scale;Functional near-infrared spectroscopy;Hand Grip Strength;Active Range of Motion (AROM);Sensory evaluation;modified Barthel index, MBI;Montreal Cognitive Assessment,MoCA; | — |
Countries
China
Contacts
Public ContactJingya Liu
China Rehabilitation Research Center
Outcome results
None listed