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Effectiveness and Safety of Cognition-Motor Mutual Enhancement Hand Rehabilitation Robot for Treating Post-Stroke Cognitive and Motor Dual Impairments: A Prospective, Assessor-Blinded, Randomized Controlled Trial

Subproject of research on key technologies and platform for intelligent stroke diagnosis, treatment, and rehabilitation intervention driven by large models: Study on the effectiveness and safety of a cognitive-motor mutually enhancing hand rehabilitation robot

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120454
Enrollment
Unknown
Registered
2026-03-16
Start date
2026-03-16
Completion date
Unknown
Last updated
2026-03-23

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

Conditions

Stroke

Interventions

Experimental group:Undergo 'conventional rehabilitation (45 minutes) and gamified robot training (30 minutes)' once daily for 15 consecutive days
Control group:Receive 'conventional rehabilitation (75 minutes)' once daily for 15 consecutive days

Sponsors

First Affiliated Hospital of Xinjiang Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age: 18-75 years old (inclusive), no gender restriction 2.Diagnostic criteria: Meet the diagnostic criteria for stroke, confirmed by cranial CT or MRI, first-time stroke or previous stroke without significant sequelae (modified Rankin Scale, mRS =13 7.Vital signs stable: blood pressure, heart rate, and other vital signs are stable 8.Informed consent: patient or legal representative signs a written informed consent form

Exclusion criteria

Exclusion criteria: 1.Cognitive function-related: Severe cognitive impairment (MoCA =26), no cognitive training needed; history of dementia or neurodegenerative diseases (Alzheimer's disease, Parkinson's disease, etc.). 2.Aphasia (including transcortical motor aphasia, sensory aphasia, mixed aphasia). 3.Upper limb function-related: Severe shoulder dislocation or subluxation (requiring reduction treatment); stage II-III shoulder-hand syndrome (severe pain and swelling); severe contracture deformity of the affected upper limb (passive joint range of motion =24 or Anxiety Scale HAMA >=29); schizophrenia or other severe mental disorders; history of drug or alcohol abuse. 7.Other diseases: Malignant tumors or expected life expectancy 3 times the upper limit of normal, creatinine >2 times the upper limit of normal); uncontrolled diabetes (fasting blood glucose >10 mmol/L or 2-hour postprandial blood glucose >16 mmol/L); hematologic diseases or coagulation disorders; active infection or fever. 8.Other conditions: Pregnant or breastfeeding women; currently participating in other clinical trials; received upper limb rehabilitation robot training within the past month; presence of pacemaker, metal implants, or other MRI contraindications (such as planned fMRI examination); other conditions deemed by the investigator unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer Assessment for Upper Extremity Motor Function (FMA-UE);Montreal Cognitive Assessment (MoCA);

Secondary

MeasureTime frame
Brunnstrom Stages;Seven-stage grading scale for upper limb recovery after hemiplegia;Hemiplegic Hand Function Assessment Scale;Electromyography;Action Research Arm Test (ARAT);Surface electromyography (sEMG) parameters;Barthel Index (ADL Assessment);Barthel Index;Neurobehavioral Cognitive Status Examination (NCSE);Brain Function MRI (fMRI);Electroencephalogram;fNIR;Self-Rating Depression Scale (SDS);Generalized Anxiety Disorder Scale (GAD-7);

Countries

China

Contacts

Public ContactGuohua Zhu

First Affiliated Hospital of Xinjiang Medical University

zhuguohua427@sina.com+86 131 9982 1134

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026