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

December 26, 2016 updated by: Dr. Gabriel Zeilig

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Hashomer, Israel, 52620
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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°

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study arm
Device: LOKOMAT
Robot-assisted gait training,8 weeks,3 sessions a week,20-45 min each session.
Other Names:
  • driven gait orthosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 and 8 weeks of training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

May 5, 2011

First Submitted That Met QC Criteria

May 5, 2011

First Posted (Estimate)

May 6, 2011

Study Record Updates

Last Update Posted (Estimate)

December 28, 2016

Last Update Submitted That Met QC Criteria

December 26, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-11-8422-GZ-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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