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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01349478

Enrollment

Registered

2011-05-06

Start date

2011-05-31

Completion date

2016-05-31

Last updated

2016-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Motor Complete Spinal Cord Injury

Keywords

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

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.

Interventions

DEVICELOKOMAT

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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°

Design outcomes

Primary

Measure	Time frame	Description
Electrical stimulation induced lower limb exercise capacity in individuals with SCI	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

Measure	Time frame	Description
Reduction of risk factors for CVD	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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026