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

May 8, 2015 updated by: University of Sao Paulo General Hospital
Patients with incomplete spinal cord injury

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 04116-040
        • Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Device: Lokomat system (Hocoma AG Switzerland)
For the robot locomotion therapy, the Lokomat system (Hocoma AG Switzerland) will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Walking Index for Spinal Cord Injury II
Time Frame: 6 weeks after treatment
6 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Linamara Rizzo Battistella, Md PhD, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

January 14, 2015

First Submitted That Met QC Criteria

January 16, 2015

First Posted (Estimate)

January 19, 2015

Study Record Updates

Last Update Posted (Estimate)

May 12, 2015

Last Update Submitted That Met QC Criteria

May 8, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0718.0.015.000-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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