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Completed

NCT Number: NCT01349478

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

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).

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Key information

Conditions

Motor Complete Spinal Cord Injury Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Paralysis Paraplegia Pathological Conditions, Signs and Symptoms Quadriplegia Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sheba medical center

Tel Litwinsky, 52620, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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°

Treatment and study plan

Lokomat

Device

Robot-assisted gait training,8 weeks,3 sessions a week,20-45 min each session.

Other names: driven gait orthosis

Primary outcomes

  1. 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 outcomes

  1. Reduction of risk factors for CVD

    Time frame: 4 and 8 weeks

    • Plasms levels of: Total cholesterol, LDL-C, HDL-C, TC/HDL, LDL/HDL, CRP, Triglycerides, IL6, fasting glucose and fasting insulin
    • blood pressure, O2 consumption, CO2 production, O2 saturation, Heart rate, RER max (respiratory exchange ratio), VE (minute ventilation), AT (Anaerobic Threshold), Work rate max

Sponsors and collaborators

Lead sponsor

Dr. Gabriel Zeilig

Other Gov

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
May 6, 2011
Registry last updated
Dec 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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