Clinical Translational Research on an Intelligent Electromyographic (EMG) Stimulation System Driven by Multidimensional Dynamic Assessment for Post-Stroke Lower Limb Rehabilitation

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600116464

Enrollment

Unknown

Registered

2026-01-09

Start date

2026-02-01

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Post-stroke lower limb motor dysfunction.

Interventions

Control Group:Traditional static neuromuscular electrical stimulation

Research Group:Intelligent Electrical Stimulation Therapy Driven by Multidimensional Dynamic Assessment

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria for stroke; 2. Stable vital signs; 3. Age 18–75 years; 4. Onset duration: 15 days to 1 year; 5. Modified Rankin Scale (mRS) score of 2–4; 6. Cooperation score S5Q >= 3, with adequate comprehension and active participation in assessments and training; 7. Informed consent signed by the patient or their legal representative.

Exclusion criteria

Exclusion criteria: 1. Progressive stroke; hyperacute stroke; transient ischemic attack; history of traumatic brain injury, encephalitis, tuberculous meningitis, or other conditions involving brain parenchyma or the central nervous system; 2. Severe cardiac diseases, including acute coronary syndrome, decompensated heart failure, uncontrolled severe arrhythmias, high-grade atrioventricular block, severe valvular heart disease, hypertrophic obstructive cardiomyopathy, active myocarditis, or pericarditis; 3. Severe hepatic or renal dysfunction; 4. Presence of other severe comorbidities, such as malignant tumors, end-stage chronic kidney disease, psychiatric disorders, or severe malnutrition; 5. Unhealed lower-limb fractures or severe osteoporosis; markedly increased muscle tone with an Ashworth scale grade of 2–4; 6. Untreated deep vein thrombosis of the lower limbs; 7. Pregnant or breastfeeding women; 8. Concurrent participation in other drug or medical device clinical trials.

Design outcomes

Primary

Measure	Time frame
Quantitative gait analysis walking speed;	—

Secondary

Measure	Time frame
Fugl-Meyer Assessment for Lower Extremity;Modified Barthel Index;Adverse events (such as muscle pain, skin irritation, arrhythmia, etc.);	—

Countries

China

Contacts

Public ContactZhou Mingchao

Shenzhen Second People's Hospital

zhoumc06@email.szu.edu.cn+86 755 8336 6388

Outcome results

None listed

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