Clinical trial NCT03477123: Evaluation of Robotic Exoskeletons Therapy for Gait Rehabilitation in Patients With Incomplete Spinal Cord Injury.
Official title: Evaluation of Robotic Exoskeletons Therapy for Gait Rehabilitation in Patients With Incomplete Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Incomplete Spinal Cord Injury
Keywords: Incomplete spinal cord injury
Walking
Rehabilitation
Robotic exoskeleton
Lead sponsor: Hospital Nacional de Parapléjicos de Toledo
Sponsor class: OTHER
Collaborators: name: Institut Guttmann
First posted: 2018-03-26
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lower extremity motor score
timeFrame: Change from Baseline Lower Extremity Motor Score at 2 months
measure: Spasticity measured by Ashworth scale
timeFrame: Change from Baseline Ashworth Scale at 2 months
measure: Ten meters walking test
timeFrame: Change from Baseline Ten Meters Walking Test at 2 months
measure: Six minutes walking test
timeFrame: Change from Baseline Six Minutes Walking Test at 2 months
measure: Time Up-and-Go Test (TUG)
timeFrame: Change from Baseline TUG Test at 2 months
measure: Walking Index for Spinal Cord Injury II (WISCI II)
timeFrame: Change from Baseline WISCI II Scale at 2 months
measure: Questionnaire: Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
timeFrame: Through study completion
Secondary outcomes:
measure: Spinal Cord Independence Measure III (SCIM III)
timeFrame: Change from Baseline SCIM III scale at 2 months
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: National Hospital for Paraplegics
Study officials:
affiliation: Head of Rehabilitation Department
name: Angel Gil-Agudo, PhD, MD
role: STUDY_CHAIR
References:
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