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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Electrical stimulation induced lower limb exercise capacity in individuals with SCI
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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°
Arms & Interventions
study arm
Intervention: LOKOMAT (Device)
Outcomes
Primary Outcomes
Electrical stimulation induced lower limb exercise capacity in individuals with SCI
Time Frame: 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 Outcomes
- Reduction of risk factors for CVD(4 and 8 weeks)
Investigators
Dr. Gabriel Zeilig
Dr. Gabriel Zeilig
Sheba Medical Center