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

Dr. Gabriel Zeilig

Status and phase

Completed

Phase 2

Phase 1

Conditions

Motor Complete Spinal Cord Injury

Treatments

Device: LOKOMAT

Study type

Interventional

Funder types

Other

Identifiers

NCT01349478

SHEBA-11-8422-GZ-CTIL

Details and patient eligibility

About

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).

Full 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.

Enrollment

11 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No 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°