Effects of System Suspended Robotic Lokomat Gait in Patients With Incomplete Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
Patients with incomplete spinal cord injury

Detailed Description
-----------------
The objective of this project is to verify the effects of suspended robotic gait training (Lokomat) in recovery of functional capacity of the lower limbs patients with incomplete spinal cord injury.

Official Title
-----------------
Effects of System Suspended Robotic Lokomat Gait in Patients With Incomplete Spinal Cord Injury

Conditions
-----------------
Spinal Cord Injury

Intervention / Treatment
-----------------
* Other: Training sessions
* Device: Lokomat system (Hocoma AG Switzerland)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical and radiological diagnosis of incomplete spinal cord injury of traumatic origin Injury time from 1 to 36 months Stability verified in clinical medical evaluation ASIA C or D Absence of severe psychiatric amendment requiring psychiatric evaluations Present functional recovery of the upper limb compatible with stages III and IV of Brunnstrom Patients cannot use a cardiac pacemaker ; have unstable angina or other decompensated heart disease; have chronic obstructive pulmonary disease; dysreflexia without having autonomic control; have some fracture of the bones of the lower limbs; tracheostomy; presenting deformity and stiffness of the hip joint, knee (20 ° or more of flexion ) and ankle ( 10 or more plantar flexion ) and pressure ulcers. Absence of illicit drug use Grant writing the informed consent to participate in the study Exclusion Criteria: Lack of resistance Disabling fatigue Worsening of spasticity which prevents the movement Body weight in excess of 150Kg Risk of osteoporosis with pathological fracture Asymmetry in the lower limbs greater than 2 cm Skin lesions and / or pressure ulcers in areas where the orthosis Lokomat pressuring

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional group<br>A group with spinal cord injury will be trained in a 30-minute session 5 times weekly for 6 weeks. Each session will be supervised by qualified staff. Patients will undergo training with gradual increase in load and speed, according to the tolerance of each patient. The body weight support progression will start at 50 % of the patient body weight. It will be changed every 2 weeks and the load will decrease 10%. The progression of speed may be accompanied during the training period. For the robot locomotion therapy, the Lokomat system (Hocoma AG Switzerland) will be used. | Other: Training sessions<br>* A group with spinal cord injury will be trained in a 30-minute session 5 times weekly for 6 weeks. Each session will be supervised by qualified staff. Patients will undergo training with gradual increase in load and speed, according to the tolerance of each patient. The body weight support progression will start at 50 % of the patient body weight. It will be changed every 2 weeks and the load will decrease 10%. The progression of speed may be accompanied during the training period.<br>Device: Lokomat system (Hocoma AG Switzerland)<br>* For the robot locomotion therapy, the Lokomat system (Hocoma AG Switzerland) will be used.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking Index for Spinal Cord Injury II |  | 6 weeks after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rehabilitation, Walking, Robotics, Neuronal Plasticity