The Effects of Passive Gait Training in Complete Motor Spinal Cord Injury (SCI)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Motor Complete Spinal Cord Injury

Intervention / Treatment
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* Device: LOKOMAT


Participation Criteria
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Eligibility Criteria
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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°

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study arm<br> | Device: LOKOMAT<br>* Robot-assisted gait training,8 weeks,3 sessions a week,20-45 min each session.<br>* Other names: driven gait orthosis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paraplegia, tetraplegia, passive gait training, O2 consumption, exercise capacity, CVD risk factors, spasticity, pain, bladder, bowel, well being