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Application of lower limb exoskeleton robot based on flexible driving joint in lower limb motor rehabilitation of stroke patients with hemiplegia

Application of lower limb exoskeleton robot based on flexible driving joint in lower limb motor rehabilitation of stroke patients with hemiplegia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042090
Enrollment
Unknown
Registered
2021-01-13
Start date
2021-01-11
Completion date
Unknown
Last updated
2021-04-19

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

Conditions

Stroke hemiplegia

Interventions

experimental group:Lower limb exoskeleton robot
control group:Routine rehabilitation treatment

Sponsors

Shandong University Qilu Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) the patients had stable vital signs; (2) the age was 18-75 years old, regardless of gender; (3) the weight was less than 85 kg, the height was 1.55-1.90 m; (4) the patients with hemiplegia after stroke, including cerebral infarction and cerebral hemorrhage, were diagnosed for the first time, and the course of disease was less than 6 months; (5) they had walking ability, but the walking stability was decreased, and they needed to walk under supervision, and the walking speed was significantly lower than that of normal people of the same age; (6) the patients with cardio hemiplegia were diagnosed as the first The patients had good lung function and enough physical strength to complete the test; (7) the range of passive motion of hip joint and knee joint was not significantly limited, and the ankle joint could be kept in a neutral position; (8) the patients had good cognitive function and could understand and actively participate in the training program. They agreed and signed the informed consent for this clinical study.

Exclusion criteria

Exclusion criteria: (1) There are three main problems: the range of motion of joints is severely limited, and walking movement is restricted; (2) fracture is not completely healed; (3) severe osteoporosis; (4) skin injury or infection of lower limbs and robot wearing parts; (5) unstable angina pectoris, severe arrhythmia and other heart diseases; (6) severe chronic obstructive pulmonary disease; (7) untreated deep vein thrombosis; (8) pregnancy or nursing (9) the researchers judged that the patients' compliance was poor and they were unable to complete the study according to the requirements; (10) other contraindications or complications that may affect walking training.

Design outcomes

Secondary

MeasureTime frame
Six minute walk test;Spasm (modified Ashworth);Fugl Meyer evaluation;Functional walking scale (FAC);Improvement of functional walking scale (FAC);The proportion of the duration of support period and swing period of the affected side's single leg;Step frequency;Gait cycle;

Primary

MeasureTime frame
Maximum walking speed of 10m;

Contacts

Public ContactZhang Zhimian

Shandong University Qilu Hospital

zhangzhimian@126.com+86 531-82166912

Outcome results

None listed

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