- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02342080
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
-
-
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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.
|
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.
|
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.
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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