spinal cord injury (SCI)
Conditions
Interventions
experimental group :cycling training with brain computer Interface based on motor imagination Intervention code
control group :conventional cycling training training
Sponsors
The First Affiliated Hospital of Nanjing Medical University(Jiangsu Provincial People's Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The vital signs are stable and suitable for exercise test; 2. Aged 18-75 years, no gender limit; 3. Traumatic spinal cord injury (including surgical trauma) confirmed by CT or MRI in accordance with the international diagnostic criteria of the Neurological Classification of Spinal Cord Injury revised by the American Society of Spinal Cord Injury in 2013; 4. The movement plane of spinal nerve injury was C5-T12, and the AIS spinal cord injury grade was C; 5. The course of the disease is more than 3 months and less than 12 months (the spinal shock stage has passed); 6. Stable spine, able to tolerate rehabilitation training; 7. Good cognitive function, able to understand and actively participate in the training program, agree to and sign the informed consent of this clinical study.
Exclusion criteria
Exclusion criteria: 1. Patients with complications that limit their exercise ability, such as lower extremity deep vein thrombosis, severe hypertension, coronary heart disease, diabetes, severe osteoporosis and female pregnancy; 2. Patients with severe anxiety and depression (SAS>50, SDS>70); 3. Limited range of lower limb movement or flexion and extension of lower limb movement due to other factors; 4. Improved Ashworth of lower limb muscle tone > Grade 2; 5. Lesions unsuitable for wearing devices, such as scalp and skull injury, lower limb skin injury or infection, resulting in inability to wear devices; 6. The researcher judged that the patients had poor compliance or did not understand the experiment and could not complete the study as required; 7. Participated in other drug or medical device clinical trials during the same period; 8. Other conditions deemed unsuitable for inclusion by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lower extremity motor score, LEMS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensory function assessment;Walking index for spinal cord injury II, WSCI-II;Functional near-infrared spectroscopy, fNIRS; | — |
Countries
China
Contacts
Public ContactLi Yongqiang
Outcome results
None listed