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

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Training sessions
Lokomat system (Hocoma AG Switzerland)
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Rehabilitation, Walking, Robotics, Neuronal Plasticity

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional group

Arm Description

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.

Outcomes

Primary Outcome Measures

Walking Index for Spinal Cord Injury II

Secondary Outcome Measures

Full Information

First Posted
January 14, 2015
Last Updated
May 8, 2015
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02342080
Brief Title
Effects of System Suspended Robotic Lokomat Gait in Patients With Incomplete Spinal Cord Injury
Official Title
Effects of System Suspended Robotic Lokomat Gait in Patients With Incomplete Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Rehabilitation, Walking, Robotics, Neuronal Plasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Training sessions
Intervention Description
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
Device
Intervention Name(s)
Lokomat system (Hocoma AG Switzerland)
Intervention Description
For the robot locomotion therapy, the Lokomat system (Hocoma AG Switzerland) will be used.
Primary Outcome Measure Information:
Title
Walking Index for Spinal Cord Injury II
Time Frame
6 weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linamara Rizzo Battistella, MD PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSP
City
Sao Paulo
ZIP/Postal Code
04116-040
Country
Brazil

12. IPD Sharing Statement

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

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