The Effects of Passive Gait Training in Complete Motor Spinal Cord Injury (SCI)
- Conditions
- Motor Complete Spinal Cord Injury
- Interventions
- Device: LOKOMAT
- Registration Number
- NCT01349478
- Lead Sponsor
- Dr. Gabriel Zeilig
- Brief Summary
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).
- Detailed Description
Cardiovascular morbidity and mortality are a source of increasing concern among people with SCI and their health providers. The importance of physical activity in reducing the risk of heart disease in this population is indisputable, but exercise opportunities for persons with SCI are limited by physiologic and functional factors. Decreased functional muscle mass, impaired autonomic control of myocardial function, and decreased venous return limits training responses.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
- 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
- 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°
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description study arm LOKOMAT -
- Primary Outcome Measures
Name Time Method Electrical stimulation induced lower limb exercise capacity in individuals with SCI 4 and 8 weeks of training The lower limb exercise capacity in response to electrical stimulation will be measured by the use of the ERGYS II system
- Secondary Outcome Measures
Name Time Method Reduction of risk factors for CVD 4 and 8 weeks 1. Plasms levels of: Total cholesterol, LDL-C, HDL-C, TC/HDL, LDL/HDL, CRP, Triglycerides, IL6, fasting glucose and fasting insulin
2. blood pressure, O2 consumption, CO2 production, O2 saturation, Heart rate, RER max (respiratory exchange ratio), VE (minute ventilation), AT (Anaerobic Threshold), Work rate max
Trial Locations
- Locations (1)
Sheba medical center
🇮🇱Tel Hashomer, Israel