Spinal Cord Injury Clinical Trial
Official title:
Evaluation of Robotic Exoskeletons Therapy for Gait Rehabilitation in Patients With Incomplete Spinal Cord Injury
The objective of the study is to assess the efficacy of the Exo-H2 robotic exoskeleton for walking rehabilitation of people with incomplete spinal cord injury.
The recovery of walking ability is a primary concern of rehabilitation programs for people
who have suffered anincomplete spinal cord injury. Robotic therapy arises from the new
concepts of neuroplasticity. One of the most novel contributions in this field is robotic
exoskeletons. However, there is still not enough scientific evidence to support the clinical
use of this technology.
The aim of this proposal is to assess the efficacy of a new model of robotic exoskeleton (Exo
H2) developed by the CSIC with HNP involvement in the context of HYPER project (Consolider
2009 call) in gait rehabilitation for people with incomplete spinal cord injury. A
multicenter study is proposed here, involving the National Hospital of Paraplegics and the
Institut Guttmann. Two randomized groups of patients with subacute incomplete spinal cord
injury will be defined. In one group, protocol gait rehabilitation based on the Exo H2 will
be established and traditional gait therapy will be adapted for control group. Both groups of
patients were assessed performing a physical exam including functional gait scales (10 MWT,
6MWT, WISCI II score, SCIM) and a biomechanical gait analysis with kinetic and kinematic
techniques. Functional assessment will be carried out before intervention, at the end of the
intervention and a follow up six weeks later.
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