Spinal cord injury
Conditions
Interventions
Robotic-Assisted Gait Training Group (RAGT):In addition to conventional physical therapy, participants in the intervention group will undergo exoskeleton-assisted walking training at a speed of 0.4 m/
Control Group (Con):Conventional physical therapy
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
20 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 20 and 70 years, regardless of sex; 2. Height between 1.42 meters and 1.93 meters; 3. Body weight less than 100 kilograms; 4. Spinal cord injury below the C4 level according to the ASIA Impairment Scale; 5. Confirmed diagnosis of both bladder and bowel dysfunction based on urodynamic examination and bowel function assessment scales. The following two conditions must be met simultaneously: (1) Urodynamic findings indicating neurogenic bladder dysfunction (meeting at least one of the following criteria): 1) Bladder capacity 500 mL; 2) Detrusor pressure 40 cmH2O; 3) Post-void residual volume > 50 mL; 4) Inability to void voluntarily; 5) Diagnosis of neurogenic bladder dysfunction confirmed by a specialist based on urodynamic test results. (2) Evidence of bowel dysfunction (meeting at least one of the following): 1) Bowel Symptom Scale (BSS) score of 1–2 points (indicating constipation); 2) Neurogenic Bowel Dysfunction Score (NBDS) > 10 points. Both of the above criteria must be met.
Exclusion criteria
Exclusion criteria: 1. A Modified Ashworth Scale (MAS) score greater than 2 for spasticity in both lower limbs; 2. Participation in exoskeleton-assisted gait training within the past 6 months; 3. Hypertension: systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg despite medication control; 4. Recent diagnosis of severe musculoskeletal disorders (e.g., unstable fractures of the limbs, severe osteoporosis, etc.); 5. Comorbidities or complications that impair cognitive or motor function (e.g., psychiatric disorders, deep vein thrombosis in both lower limbs, etc.); 6. Body weight greater than 100 kg; 7. Other conditions deemed inappropriate for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neurogenic Bladder Symptoms Score, NBSS; Neurogenic Bowel Dysfunction Score, NBDS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Urodynamics; International Consultation on Incontinence Questionnaire–Urinary Incontinence Short Form, ICI-Q-Short Form;Bristol Stool Form Scale , BSS; | — |
Countries
China
Contacts
Public ContactHong-Chen He
West China Hospital, Sichuan University
Outcome results
None listed