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Clinical validation of SE-NaturalGait in clinical application

Clinical validation of SE-NaturalGait in clinical application

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026792
Enrollment
Unknown
Registered
2019-10-22
Start date
2019-11-01
Completion date
Unknown
Last updated
2019-10-28

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

Conditions

stroke

Interventions

Intervention group:lower limb robotics training
control group:walking ability training

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 20 to 80 years; 2. Hemiparetic stroke patients, Brunnstrom stage between II to IV; 3. According to the "National Cerebrovascular Disease Conference" (2010 edition), diagnosed as stroke; 4. Disease duration: 14 days to 12 months; 5. Voluntary signing of informed consent and willingness to participate in this study.

Exclusion criteria

Exclusion criteria: 1. In combination with severe cardiopulmonary liver and kidney dysfunction, not suitable for rehabilitation(in the past 6 months, due to any cause of congestive heart failure (CHF) attack or aggravation. Need to change the dosage, diet or any heart attacks that needs to be admitted to hospital were seen as CHF; Known CHF with valvular disease; open thoracic cardiac surgery (eg, coronary artery bypass, valve replacement); acute myocardial infarction within 3 months; acute MI on admission with signs or symptoms, including electrocardiogram findings; suspected aortic dissection on admission; acute arrhythmia with hemodynamic instability (including any tachycardia or bradycardia); liver dysfunction(more than 1.2 times the normal range); serum creatinine, urea nitrogen exceeds 1.2 times the normal range; existing acute or chronic lung disease); poor blood pressure and blood glucose control, blood pressure test for systolic blood pressure >= 140mmHg, diastolic blood pressure >= 90mmHg. 2. Acute disease such as acute infection, fracture or dislocation (fracture or dislocation in healing period which is not properly fixed). 3. Participating in other relevant clinical researchers at the same time. 4. Pregnant or plan for pregnancy. 5. History of malignant tumor. 6. Contraindications for using lower limb rehabilitation robots.

Design outcomes

Primary

MeasureTime frame
FAC score;

Secondary

MeasureTime frame
Berg score;Fugl-Meyer for lower limb;Rivermead mobility score;ADL;time for 10 meter walking;

Countries

China

Contacts

Public ContactBai Yulong

Huashan Hospital, Fudan University

dr_baiyl@fudan.edu.cn+86 18121186606

Outcome results

None listed

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