The effect of soft-exosuit on lower extremity sEMG and Gait in patients after stroke

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300068869

Enrollment

Unknown

Registered

2023-03-01

Start date

2023-03-01

Completion date

Unknown

Last updated

2023-05-22

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

Conditions

Stroke

Interventions

1:Soft-exosuit (power on)

2:Soft-exosuit (power off)

3:No Soft-exosuit

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Patients whose diagnoses are all in accordance with the Diagnostic Points for Various Types of Cerebrovascular Diseases revised by the Fourth Academic Conference on Cerebrovascular Diseases of the Chinese Medical Association, and who are clinically diagnosed with cerebral infarction or cerebral hemorrhage after cranial CT or MRI examination. (2) Unilateral hemorrhagic or ischemic cerebral infarction (3) First onset, duration of illness 1 - 6 months (4) Age from 18 to 65 (5) No severe cognitive impairment and aphasia, with a Mini-Mental State Examination (MMSE) score of >=23, or an MMSE score of >=17 if aphasia is present (6) Brunstrom (affected lower extremity)>= ? (7) Modified Ashworth score (affected lower extremity)>= 3 (8) Functional ambulation classification >=3 (9) walk independently or with assistance for at least 14m (10) The affected ankle joint has sufficient passive movement angle, and if there is plantarflexion contracture of the ankle joint, the contracture angle does not exceed 5°

Exclusion criteria

Exclusion criteria: (1)The disease is not yet stable (2)Severe cognitive impairment (3)With severe musculoskeletal, cardiac, neurological, cutaneous and vestibular system comorbidities (4)Severe peripheral arterial disease (5)Resting heart rate below 50 beats per minute or above 100 beats per minute, resting blood pressure below 90/60 mmHg or above 200/100 mmHg (6)Any contraindications to exoskeleton use, such as polyurethane allergy, leg length discrepancies, height/weight restrictions, open ulcers at device contact points, etc.

Design outcomes

Primary

Measure	Time frame
iEMG;BDSI;ASI;	—

Secondary

Measure	Time frame
Step speed;Step length;	—

Countries

China

Contacts

Public ContactRuimou Xie

Beijing Tsinghua Changgung Hospital

xrma03496@btch.edu.cn+86 135 0032 4933

Outcome results

None listed

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