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

Primary Purpose

Motor Complete Spinal Cord Injury

Status

Completed

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

LOKOMAT

About this trial

This is an interventional supportive care trial for Motor Complete Spinal Cord Injury focused on measuring paraplegia, tetraplegia, passive gait training, O2 consumption, exercise capacity, CVD risk factors, spasticity, pain, bladder, bowel, well being

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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°

Sites / Locations

Sheba medical center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

study arm

Arm Description

Outcomes

Primary Outcome Measures

Electrical stimulation induced lower limb exercise capacity in individuals with SCI

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

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

Full Information

NCT ID

NCT01349478

First Posted

May 5, 2011

Last Updated

December 26, 2016

Sponsor

Dr. Gabriel Zeilig

1. Study Identification

Unique Protocol Identification Number

NCT01349478

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dr. Gabriel Zeilig

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Motor Complete Spinal Cord Injury

Keywords

paraplegia, tetraplegia, passive gait training, O2 consumption, exercise capacity, CVD risk factors, spasticity, pain, bladder, bowel, well being

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

study arm

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

LOKOMAT

Other Intervention Name(s)

driven gait orthosis

Intervention Description

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

Primary Outcome Measure Information:

Title

Electrical stimulation induced lower limb exercise capacity in individuals with SCI

Description

The lower limb exercise capacity in response to electrical stimulation will be measured by the use of the ERGYS II system

Time Frame

4 and 8 weeks of training

Secondary Outcome Measure Information:

Title

Reduction of risk factors for CVD

Description

Time Frame

4 and 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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°

Overall Study Officials: