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

NCT ID: NCT02342080

Last Updated: 2015-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-02-28

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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Interventional group

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.

Group Type: EXPERIMENTAL

Training sessions

Intervention Type: OTHER

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.

Lokomat system (Hocoma AG Switzerland)

Intervention Type: DEVICE

For the robot locomotion therapy, the Lokomat system (Hocoma AG Switzerland) will be used.

Interventions

Training sessions

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.

Intervention Type: OTHER

Lokomat system (Hocoma AG Switzerland)

For the robot locomotion therapy, the Lokomat system (Hocoma AG Switzerland) will be used.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linamara Rizzo Battistella, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSP

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

0718.0.015.000-11

Identifier Type: -

Identifier Source: org_study_id