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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01349478
First Posted: May 6, 2011
Last Update Posted: December 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Gabriel Zeilig, Sheba Medical Center
  Purpose
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 Device: LOKOMAT Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 Dr. Gabriel Zeilig, 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 ]
    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 ]
    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


Enrollment: 11
Study Start Date: May 2011
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: study arm 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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°
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01349478


Locations
Israel
Sheba medical center
Tel Hashomer, Israel, 52620
Sponsors and Collaborators
Dr. Gabriel Zeilig
Investigators
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:
Publications:
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: Dr. Gabriel Zeilig, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01349478     History of Changes
Other Study ID Numbers: SHEBA-11-8422-GZ-CTIL
First Submitted: May 5, 2011
First Posted: May 6, 2011
Last Update Posted: December 28, 2016
Last Verified: December 2016

Keywords provided by Dr. Gabriel Zeilig, Sheba Medical Center:
paraplegia
tetraplegia
passive gait training
O2 consumption
exercise capacity
CVD risk factors
spasticity
pain
bladder, bowel
well being

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System