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

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ClinicalTrials.gov Identifier: NCT02342080
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Brief Summary:
Patients with incomplete spinal cord injury

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Other: Training sessions Device: Lokomat system (Hocoma AG Switzerland) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effects of System Suspended Robotic Lokomat Gait in Patients With Incomplete Spinal Cord Injury
Study Start Date : March 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Walking Index for Spinal Cord Injury II [ Time Frame: 6 weeks after treatment ]


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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02342080


Locations
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Brazil
Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSP
Sao Paulo, Brazil, 04116-040
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Linamara Rizzo Battistella, MD PhD University of Sao Paulo

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02342080     History of Changes
Other Study ID Numbers: 0718.0.015.000-11
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015

Keywords provided by University of Sao Paulo General Hospital:
Rehabilitation
Walking
Robotics
Neuronal Plasticity

Additional relevant MeSH terms:
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Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System