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
Information provided by:
Sheba Medical Center Identifier:
First received: May 5, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
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).

Condition Intervention Phase
Motor Complete Spinal Cord Injury
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 20
Study Start Date: May 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: LOKOMAT
    Robot-assisted gait training,8 weeks,3 sessions a week,20-45 min each session.
    Other Name: driven gait orthosis
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.

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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°
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01349478

Contact: Moshe Berg, Medical Student 0526007887
Contact: Evgeni Gaidukov, M.D 0547682786

Sheba medical center Not yet recruiting
Tel Hashomer, Israel, 52620
Sponsors and Collaborators
Sheba Medical Center
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
  More Information

Additional Information:
American Spinal Injury Association/International Medical Society of Paraplegia International Standards for Neurological and Functional Classification of Spinal Cord Injury Patients. Chicago, IL: American Spinal Injury Association/International Medical Society of Paraplegia; 2000.
Marino RJ Reference Manual American Spinal Cord Association 2000
De Vivo MJ Long term survival and causes of death in Spinal Cord Injury Clinical Outcomes from the model systems 1995
Mark S. Nash. Cardiovascular Fitness and Exercise Prescription after Spinal Cord Injury. Spinal Cord Medicine. Principles and Practice. Vernon W. Lin 2010 pages 848-855

Responsible Party: Gabriel Zeilig, Sheba Medical Center Identifier: NCT01349478     History of Changes
Other Study ID Numbers: SHEBA-11-8422-GZ-CTIL 
Study First Received: May 5, 2011
Last Updated: May 5, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
passive gait training
O2 consumption
exercise capacity
CVD risk factors
bladder, bowel
well being

Additional relevant MeSH terms:
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries processed this record on May 23, 2016