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A multicenter randomized controlled clinical study of lower limb exoskeleton rehabilitation robot on walking function and neuroelectrophysiology of stroke patients

A multicenter randomized controlled clinical study of lower limb exoskeleton rehabilitation robot on walking function and neuroelectrophysiology of stroke patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096316
Enrollment
Unknown
Registered
2025-01-21
Start date
2022-11-03
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

stroke

Interventions

control group:Routine rehabilitation training
Intervention group:Lower limb robot rehabilitation training

Sponsors

Zhongda Hospital Affiliated to Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Age 18-80 years old, clear consciousness, no serious cognitive impairment, able to complete the corresponding assessment; First onset, unilateral hemiplegia, 1-6 months after the disease; Stable vital signs, good cardiopulmonary function; Can understand and cooperate with the treatment of this study; The main muscle tone of lower limbs assessed by modified Ashworth spasm is less than or equal to grade 2; FAC score 0-2 points; All subjects are aware of the trial rules, agree to participate in the trial, and sign the informed consent.

Exclusion criteria

Exclusion criteria: Instability of lower limb fracture and skin lesions; Patients with severe depression, anxiety or severe mental illness; Serious musculoskeletal diseases (such as amputation, arthritis, etc.) caused by limb joint movement pain, activity limitation and other functional disorders; Complicated with serious diseases of cardiovascular and cerebrovascular system, digestive system and endocrine system; Posterior cerebral circulation lesions.

Design outcomes

Primary

MeasureTime frame
functional ambulation category;

Secondary

MeasureTime frame
Lower extremity portion of Fugl-Meyer Scale;sMEG;Berg Balance Scale (BBS);ADL;Timed Up and Go Test;Motor Evoked Potential;

Countries

China

Contacts

Public ContactWang Hongxing

Zhongda Hospital Affiliated to Southeast University

wang_hongxing@163.com+86 137 7082 3776

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 20, 2026