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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Gabriel Zeilig, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01349478
First received: May 5, 2011
Last updated: December 26, 2016
Last verified: December 2016
May 5, 2011
December 26, 2016
May 2011
May 2016   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01349478 on ClinicalTrials.gov Archive Site
Reduction of risk factors for CVD [ Time Frame: 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
Same as current
Not Provided
Not Provided
 
The Effects of Passive Gait Training in Complete Motor Spinal Cord Injury (SCI)
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
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).
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.
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Motor Complete Spinal Cord Injury
Device: LOKOMAT
Robot-assisted gait training,8 weeks,3 sessions a week,20-45 min each session.
Other Name: driven gait orthosis
Experimental: study arm
Intervention: Device: LOKOMAT

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
May 2016
May 2016   (Final data collection date for primary outcome measure)

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°
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01349478
SHEBA-11-8422-GZ-CTIL
No
Not Provided
Not Provided
Dr. Gabriel Zeilig, Sheba Medical Center
Dr. Gabriel Zeilig
Not Provided
Principal Investigator: Gabriel Zeilig, M.D Sheba Medical Center
Study Director: Moshe Berg, Medical Student Sheba Medical Center
Study Director: Evgeni gaidukov, M.D Sheba Medical Center
Study Director: Shirley Ackerman-Laufer, B.A Sheba Medical Center
Study Director: Shlomit Siman, B.A. Sheba Medical Center
Sheba Medical Center
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP