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The effectiveness and safety of a new lower limb exoskeleton rehabilitation device

The effectiveness and safety of a new lower limb exoskeleton rehabilitation device for SCI walking training: a multi-site prospective trial

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900021037
Enrollment
Unknown
Registered
2019-01-26
Start date
2018-07-31
Completion date
Unknown
Last updated
2019-01-28

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

Conditions

Spinal cord injury

Interventions

Case series:lower limb exoskeleton rehabilitation device produced by Buffalo Robot Technology (Chengdu) Co., Ltd.

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 15 to 75 years old male and female; 2. Diagnosed as spinal cord injury with lesion level T2-L3 by the investigator; 3. Using the American Spinal Injury Association (ASIA) assess the degree of patients with spinal cord injury, included ASIA- A or B; 4. The subject may stand by the help of a standing frame or other fixed aid but cannot walk independently; 5. Subjects were able to understand the purpose of the study, showed sufficient adherence to the study protocol, and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Tension: use modified Ashworth scale to assess both lower limbs, MAS=grade 2; 2. After drug control, systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg; 3. Uncontrollable orthostatic hypotension; 4. Joint deformity, tendon contracture and joint diseases (such as arthritis, artificial joint patients); 5. Severe skeletal deformity and ligament rupture; 6. Unstable limb fractures; 7. Comorbidities or complications that limit the patient's mobility; 8. Mental illness, hearing impairment, understanding disorder; 9. Important organ failure or other serious illness; 10. Pregnant women, lactating women or women of childbearing age who plan to have a pregnancy during the trial; 11. Loss of spinal stability; 12. SpO2<90% at rest and SpO2<88% under exercise condition; 13. Deep venous thrombosis of both lower extremities; 14. Routine abnormalities in blood, urine and stool which are not suitable for inclusion by the investigator; 15. The investigator judges other circumstances that are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
6minute-walking test(6MWT);

Secondary

MeasureTime frame
10m walking test;Hoffer walking ability grading;ASIA lower extremity exercise score (LEMS);spinal cord function independence assessment (SCIM);spinal cord injury walking index II (WISCI II);adverse event;

Countries

China

Contacts

Public ContactHe Hongchen

West China Hospital, Sichuan University

xiaohe0613@foxmail.com+86 18980602262

Outcome results

None listed

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