Motor Complete Spinal Cord Injury Clinical Trial
Official title:
Electrical Stimulation Induced Lower Limb Exercise Capacity, Cardiorespiratory Response, Cardiovascular Risk Factors and Muscle Activity Patterns in Response to Robotic Assisted Treadmill Gait Training in Individuals With Complete Motor Spinal Cord Injury
| Verified date | December 2016 |
| Source | Sheba Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Interventional |
The purpose of this study is to determine whether a three times per week, 2 month robotic assisted treadmill gait training program, will beneficially affect the fitness, physical and psychological well-being, and the vascular and metabolic cardiovascular risk factors in individuals with complete motor Spinal Cord Injury (SCI).
| Status | Completed |
| Enrollment | 11 |
| Est. completion date | May 2016 |
| Est. primary completion date | May 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 55 Years |
| Eligibility |
Inclusion Criteria: - Male and non-pregnant non-lactating female - At least 6 months after injury - Complete (AIS A-B) cervical (C4-8) or thoracic (T1-T6) spinal cord injury according to American Spinal Injury Association (AIS) guidelines. - Under 100 kg and between 155 - 200 cm of height Exclusion Criteria: - History of severe neurological injuries other than SCI (MS, CP, ALS, TBI etc). - Severe concurrent medical diseases: infections, heart or lung, pressure sores, etc - Unstable spine or unhealed limbs or pelvic fractures - Psychiatric or cognitive situations that may interfere with the trial - Spasticity above 3 degree according to Ashworth scale - Reduced range of motion of knee/hip > 15° |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Israel | Sheba medical center | Tel Hashomer |
| Lead Sponsor | Collaborator |
|---|---|
| Dr. Gabriel Zeilig |
Israel,
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* Note: There are 17 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Electrical stimulation induced lower limb exercise capacity in individuals with SCI | The lower limb exercise capacity in response to electrical stimulation will be measured by the use of the ERGYS II system | 4 and 8 weeks of training | No |
| Secondary | Reduction of risk factors for CVD | Plasms levels of: Total cholesterol, LDL-C, HDL-C, TC/HDL, LDL/HDL, CRP, Triglycerides, IL6, fasting glucose and fasting insulin blood pressure, O2 consumption, CO2 production, O2 saturation, Heart rate, RER max (respiratory exchange ratio), VE (minute ventilation), AT (Anaerobic Threshold), Work rate max |
4 and 8 weeks | Yes |