Clinical trial NCT01349478: The Effects of Passive Gait Training in Complete Motor Spinal Cord Injury (SCI)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Motor Complete Spinal Cord Injury
Keywords: paraplegia
tetraplegia
passive gait training
O2 consumption
exercise capacity
CVD risk factors
spasticity
pain
bladder, bowel
well being
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-05-06
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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°

Primary outcomes:
measure: Electrical stimulation induced lower limb exercise capacity in individuals with SCI
timeFrame: 4 and 8 weeks of training
Secondary outcomes:
measure: Reduction of risk factors for CVD
timeFrame: 4 and 8 weeks
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba medical center
Study officials:
affiliation: Sheba Medical Center
name: Gabriel Zeilig, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheba Medical Center
name: Moshe Berg, Medical Student
role: STUDY_DIRECTOR
affiliation: Sheba Medical Center
name: Evgeni gaidukov, M.D
role: STUDY_DIRECTOR
affiliation: Sheba Medical Center
name: Shirley Ackerman-Laufer, B.A
role: STUDY_DIRECTOR
affiliation: Sheba Medical Center
name: Shlomit Siman, B.A.
role: STUDY_DIRECTOR
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