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

NCT02342080 | Completed DMC

• 1 other identifier: 0718.0.015.000-11
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with incomplete spinal cord injury

Conditions

Spinal Cord Injury

Keywords

Rehabilitation; Walking; Robotics; Neuronal Plasticity

Outcome Measures

Primary Outcomes (1)

• Walking Index for Spinal Cord Injury II

  6 weeks after treatment

Study Arms (1)

Interventional group

EXPERIMENTAL

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; Device: Lokomat system (Hocoma AG Switzerland)

Interventions

Training sessions 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.

Interventional group

Lokomat system (Hocoma AG Switzerland) DEVICE

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

Interventional group

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

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

São Paulo, São Paulo, 04116-040, Brazil

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Linamara Rizzo Battistella, MD PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2015
• First Posted: January 19, 2015
• Study Start: March 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: February 1, 2015
• Last Updated: May 12, 2015

Record last verified: 2015-05

Locations

BR (1)