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

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02342080
• Other study ID #: 0718.0.015.000-11
• Status: Completed
• Phase: N/A
• First received: January 14, 2015
• Last updated: May 8, 2015
• Start date: March 2013
• Est. completion date: February 2015

Study information

• Verified date: May 2015
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Patients with incomplete spinal cord injury

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

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.

Locations

Country	Name	City	State
Brazil	Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSP	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking Index for Spinal Cord Injury II		6 weeks after treatment	Yes