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Study on the improvement effect of wearable functional electrical stimulation on gait in stroke patients

Study on the improvement effect of wearable functional electrical stimulation on gait in stroke patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074706
Enrollment
Unknown
Registered
2023-08-14
Start date
2023-08-31
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Stroke

Interventions

Experimental group:40 minute routine rehabilitation treatment+20 minute knee ankle joint FES walking training
Control group:40 minute routine rehabilitation treatment+20 minute routine walking training

Sponsors

Huashan Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Volunteer to participate in the experiment and sign an informed consent form. (2) Conforming to the diagnostic criteria of the Chinese Classification of Cerebrovascular Diseases 2015, diagnosed with cerebral infarction, cerebral embolism, or cerebral hemorrhage through brain MRI or CT examination, with unilateral limb motor dysfunction; (3) Upper limb basket like flexion, lower limb with foot droop, knee weakness, or knee overextension; (4) The course of the disease is not limited; (5) Male or female, age: 18-80 years old; (6) Stable condition, clear consciousness, stable vital signs, understanding and able to execute instructions; (7) Control blood pressure at<140/90mmHg; (8) Brunnstrom staging of lower limbs above stage II; (9) Able to walk at least 10 meters independently or with minimal assistance; (10) The ankle, knee, and elbow joints can passively move to a neutral position; (11) The modified Ashworth scale (MAS) score of the affected lower limb was = 2;

Exclusion criteria

Exclusion criteria: (1) Implantation of cardiac pacemakers and installation of metal instruments in the body; (2) Skin damage at the electrode placement location; (3) There are other problems such as common peroneal nerve injury, myasthenia gravis, and muscle diseases in the area to be stimulated that cannot complete normal neuromuscular electrical stimulation. (4) The modified Ashworth scale (MAS) score of the affected lower limb was greater than 2, indicating significant joint contracture. (5) Lower limb fractures; (6) Severe depression and mental illness; (7) MMSE score<23 points; (8) Visual impairment; (9) Individuals with cancer or malignant tumors; (10) Pregnant women; (11) Severe complications and unstable condition; (12) There is a risk of falling.

Design outcomes

Primary

MeasureTime frame
Lower limb Fugl Meyer motor function scale score;

Secondary

MeasureTime frame
Berg Balance Scale;AEMG;pace;stride;

Countries

China

Contacts

Public ContactWuYi

Huashan Hospital of Fudan University

wuyi4000@163.com+86 130 0317 6229

Outcome results

None listed

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