Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01349478
First received: May 5, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted

May 5, 2011
May 5, 2011
May 2011
December 2011   (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 ] [ Designated as safety issue: No ]
The lower limb exercise capacity in response to electrical stimulation will be measured by the use of the ERGYS II system
Same as current
No Changes Posted
Reduction of risk factors for CVD [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: Yes ]
  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
Endpoint Classification: Safety/Efficacy Study
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
March 2012
December 2011   (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°
Both
18 Years to 55 Years
No
Contact: Moshe Berg, Medical Student 0526007887 moshberg@gmail.com
Contact: Evgeni Gaidukov, M.D 0547682786 evgeniga@gmail.com
Israel
 
NCT01349478
SHEBA-11-8422-GZ-CTIL
No
Gabriel Zeilig, Sheba Medical Center
Sheba Medical Center
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
May 2011

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