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A prospective, multicenter, randomized controlled, non inferiority trial to evaluate the effectiveness and safety of the lower extremity exoskeleton

A prospective, multicenter, randomized controlled, non inferiority trial to evaluate the effectiveness and safety of the lower extremity exoskeleton

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044475
Enrollment
Unknown
Registered
2021-03-19
Start date
2019-06-26
Completion date
Unknown
Last updated
2021-09-20

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

Conditions

Hemiplegia after stroke

Interventions

experimental group:The lower limb exoskeleton rehabilitation training is conducted twice a day, 30 minutes a time, and 5 days a week.
control group:Routine walking training is conducted twice a day, 30 minutes a time, and 5 days a week.

Sponsors

The First Affiliated Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) The vital signs of patient are stable , suitable for exercise test; (2) Aged 18 to 75 years; (3) Weight <= 85kg, height 1.5m to 90m; (4) Patients with hemiplegia after stroke, including cerebral infarction and cerebral hemorrhage, were diagnosed for the first time; (5) With upper limb strength, able to hold the balance bar; (6) They have walking ability, but their walking stability is decreased. They need to walk under supervision, and their walking speed is significantly lower than that of normal people of the same age; (7) The passive range of motion of hip joint and knee joint is not limited obviously, and the passive range of motion of ankle joint can be kept in neutral position; (8) Cognitive function is good, can understand and actively participate in the training program, agree and sign the informed consent of this clinical study.

Exclusion criteria

Exclusion criteria: (1) The range of motion of joints is severely limited, which limits the walking movement; (2) Incomplete union of fracture; (3) Severe osteoporosis; (4) Skin injury or infection of lower limbs; (5) Unstable angina pectoris, serious arrhythmia and other heart diseases; (6) Severe chronic obstructive pulmonary disease; (7) Untreated deep venous thrombosis; (8) Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
improvement of 6 minutes walking distance;

Secondary

MeasureTime frame
Modified Ashworth;fu'g'l-meyer score;functional ambulation category scale;6 minutes walking distance;pulse;stance phase and swing phase proportion of affected side;gait cadence;gait cycle;

Countries

China

Contacts

Public ContactLi Jian'an

The First Affiliated Hospital of Nanjing Medical University

lijianan@carm.org.cn+86 13705161766

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 14, 2026