Spinal Cord Injuries
Conditions
Brief summary
Spinal cord injury (SCI) is a common and severe traumatic central nervous system injury in clinical practice. Currently, the treatment of SCI remains a worldwide challenge.International studies have confirmed that TSCS is an effective non-invasive technique to activate the body's movement-related circuits. This method utilizes a unique stimulation waveform that is transmitted through electrodes placed on the skin of the spine and spreads through the dorsal roots (DRs) to activate the spinal cord neural circuits.The main objective of this study is to have patients with chronic incomplete (AIS B/C/D) spinal cord injuries wear transcutaneous spinal cord electrical stimulator and undergo Kunming locomotor training for 6 months, observe the synergistic effects of the two, and evaluate whether this treatment method can improve patients' motor functions.
Interventions
COMBINATION_PRODUCTTranscutaneous spinal cord electrical stimulation and Kunming Locomotor Training
Patients will undergo Kunming Locomotor Training along with transcutaneous spinal cord stimulation. . The training is at least 1 hour per day, 5 hours per week, for 6 consecutive months.
Sponsors
Kunming Tongren Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
16 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Chronic (≧6 months) paraplegics (T1-T10) with incomplete(AIS B/C/D) spinal cord injury Incomplete aged 16-50 years; * 2.Subjects must be able to read, understand, and complete the Visual Analogue Scale; * 3.Subjects voluntarily sign the informed consent form approved by the ethics committee.
Exclusion criteria
* 1\. Obvious renal, cardiovascular, hepatic, and mental diseases; * 2.Pregnant or lactating women and women of childbearing age who are unwilling to use contraception; * 3\. Limb contracture deformity; * 4\. Modified Ashworth \> Grade 2; * 5\. Unhealed fractures; * 6\. The subject is currently participating in other studies; * 7\. The researcher's opinion is that the subject does not comply with the research protocol and/or is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Kunming Locomotor Scale (KLS) at 6 months | Day 0, Month 6 | Scale from minimum (1) to maximum (10), higher scales mean a better outcome. |
| Change from Baseline 10 Meter Walk Test (10mWT) at 6 months | Day 0, Month 6 | The primary measure obtained from the test is the walking speed, which is calculated by dividing the distance by the time taken to complete the walk. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Spinal cord injury functional ambulation profile (SCI-FAP) at 6 months | Day 0, Month 6 | Higher scores generally indicate greater independence and better walking ability. |
| Change from Lower extremity motor score(LEMS) at 6 months | Day 0, Month 6 | a lower score indicates greater motor impairment in the lower extremities |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from Walking Index for Spinal Cord Injury (WISCI) at 6 months | Day 0, Month 6 | Higher scores generally indicate greater independence. |
Contacts
Primary ContactHui Zhu, Bachelor
Outcome results
None listed