Evaluation of Robotic Exoskeletons Therapy for Gait Rehabilitation in Patients With Incomplete Spinal Cord Injury.

Hospital Nacional de Parapléjicos de Toledo

Status

Completed

Conditions

Incomplete Spinal Cord Injury

Spinal Cord Injury

Treatments

Device: Walking therapy with Exo-H2 exoskeleton

Study type

Interventional

Funder types

Other

Identifiers

NCT03477123

PI15/01437

Details and patient eligibility

About

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.

Full description

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.

Enrollment

20 patients

Sex

All

Ages

16 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Incomplete Spinal Cord Syndrome, ASIA scale C or D
enough strength in the upper extremities to handle a walker or crutches (triceps brachial muscle balance ≥ 3)
Age between 16 and 70 y.o.
Heigth: 1.6-1.9m
Weigth less than 120Kg
Stable medical condition between 6 weeks and 18 months since injury.
Subjects must tolerate standing and be included in walking rehabilitation program in the center.
Lower limb spasticity should be lower than 3 as measyred by Ashworth scale.

Exclusion criteria

Cardiovascular diseases.
Upper limb pathology of any kind.
irreducible flexo or arthrodesis in lower limb joints, 2 or more osteoporotic fractures in the lower limbs in the last 2 years
Uncontrolled epilepsy.
Ulcers sores at the contact points with the exoskeleton.
Refuse to participate.