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Study on the effect of paraplegic exoskeleton robot on multiple system functions of patients with complete spinal cord injury: a randomized controlled trial.

Study on the effect of paraplegic exoskeleton robot on multiple system functions of patients with complete spinal cord injury

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035955
Enrollment
Unknown
Registered
2020-08-20
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-08-24

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

Conditions

Spinal cord injury

Interventions

trial group:Training of paraplegic exoskeleton robot and routine rehabilitation
control group:Routine rehabilitation

Sponsors

General Hospital of Western War Zone
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) 15 <= age <= 75, gender unlimited; (2) The researchers diagnosed spinal cord injury with t2-l1 injury plane; (3) According to the international standard neurological classification of spinal cord injury of American Spinal Injury Association (Asia), the neural plane of patients with spinal cord injury was evaluated; (4) The skin is intact and the limbs are intact; (5) Height 155-190cm, weight no more than 90kg; (6) The subjects could stand with the help of stand frame or other fixed AIDS but could not walk independently; (7) Subjects were able to understand the purpose of the study, demonstrate sufficient compliance with the study protocol, and sign informed consent.

Exclusion criteria

Exclusion criteria: (1) The Ashworth grade of muscle tension improvement in both lower limbs was >= 2. (2) After drug control, systolic blood pressure was more than 140 mmHg or diastolic blood pressure was more than 90 mmHg. (3) Antibiotics and probiotics have been used in the past month. (4) Patients with pulmonary infection and urinary tract infection. (5) Serious musculoskeletal system diseases (unstable limb fracture, joint tendon contracture, etc.). (6) The patients' cognitive and activity abilities are limited by the complications (such as mental disease, postural hypotension, deep vein thrombosis of both lower limbs, important organ failure, etc.). (7) Pregnant women, lactating women or women of childbearing age who plan to have a pregnancy during the trial. (8) Other conditions that the researchers judged unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
International basic data set of intestinal function in spinal cord injury ;International basic data set of urinary tract function in spinal cord injury ;Short Form-36;Number of bowel movements;Wexner constipation score;Bristol fecal character classification;Spinal Cord Independence Measure;Spinal cord injury subjects balance test;Finger-other finger test;

Secondary

MeasureTime frame
rating of perceived exertion;Ventilation function index of lung;Urodynamic examination;Modified Ashworth spasticity scale;Limb circumference;Bone density;Somatosensory evoked potential;6-Minute Walk Test;10-Meter Walk Time;Visual analogy score;

Countries

China

Contacts

Public ContactWang Wenchun

General Hospital of Western Theater Command of PLA

wwc1977@foxmail.com+86 18908069418

Outcome results

None listed

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