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

University of Sao Paulo General Hospital

Status: Completed

Conditions: Spinal Cord Injury

Treatments: Other: Training sessions; Device: Lokomat system (Hocoma AG Switzerland)

Study type: Interventional

Funder types: Other

Identifiers

NCT02342080

0718.0.015.000-11

Details and patient eligibility

About

Patients with incomplete spinal cord injury

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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15 participants in 1 patient group

Interventional group

Experimental group

Description:

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.

Treatment:

Other: Training sessions

Device: Lokomat system (Hocoma AG Switzerland)