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Completed

NCT Number: NCT02342080

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

Patients with incomplete spinal cord injury

Completed

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

São Paulo, 04116-040, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Training Sessions

Other

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.

Lokomat system (Hocoma AG Switzerland)

Device

For the robot locomotion therapy, the Lokomat system (Hocoma AG Switzerland) will be used.

Primary outcomes

  1. Walking Index for Spinal Cord Injury II

    Time frame: 6 weeks after treatment

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jan 19, 2015
Registry last updated
May 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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