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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
  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: 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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349478

Contacts
Contact: Moshe Berg, Medical Student 0526007887 moshberg@gmail.com
Contact: Evgeni Gaidukov, M.D 0547682786 evgeniga@gmail.com

Locations
Israel
Sheba medical center Not yet recruiting
Tel Hashomer, Israel, 52620
Sponsors and Collaborators
Sheba Medical Center
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:
QUALITY OF LIFE QUESTIONNAIRE  This link exits the ClinicalTrials.gov site
BOWEL FUNCTION QUESTIONNAIRE  This link exits the ClinicalTrials.gov site
LOWER URINARY TRACT FUNCTION QUESTIONNAIRE  This link exits the ClinicalTrials.gov site
PAIN QUESTIONNAIRE  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Gabriel Zeilig, Sheba Medical Center
ClinicalTrials.gov 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:
paraplegia
tetraplegia
passive gait training
O2 consumption
exercise capacity
 CVD risk factors
spasticity
pain
bladder, bowel
well being

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

ClinicalTrials.gov processed this record on June 18, 2013