Clinical trial NCT04383873: Effectiveness Analysis of Armeo Spring Device as a Rehabilitation Treatment in Spinal Cord Injured Patients
Official title: Effectiveness Analysis of Armeo Spring Device as a Rehabilitation Treatment in Spinal Cord Injured Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury Cervical
Keywords: Effectiveness
Rehabilitation
Upper extremity
Spinal Cord Injury cervical
Robotic device
Lead sponsor: Hospital Nacional de Parapléjicos de Toledo
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 34
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Loss of motor function is a consequence after a spinal cord injury (SCI). The incidence of SCI varies greatly from 12.1 to 57.8 cases per million depending on the country. More than 50% of people with SCI have impaired upper limb (UL) function, experiencing limitations in performing functional tasks. In this context, one of the rehabilitation objectives is to achieve the maximum level of independence in the patient in the performance of activities of daily living (ADL).

Within the clinical setting, the main motivation in the use of robotic devices and/or exoskeletons for a rehabilitation purpose focuses on the fact that these help therapists in administering repetitive manual therapies to patients during exercises. There is evidence that the amount of therapy patients receive is insufficient. Without creating additional time demands on clinicians, robotic devices can perform the repetitive mechanical aspects of therapy, increasing the amount of therapy that patients receive. However, the current evidence in stroke patients suggests that the improvements observed are due to the intensity of the therapy, regardless of whether the administration of rehabilitation is due to robotic devices and/or traditional means.

The main objective of this study is to analyze the effectiveness of the commercial Armeo® Spring system (Hocoma AG, Switzerland) and a Virtual Reality application to repeatedly work the ADL from drinking from a glass, in people with cervical SCI. The ADL of drinking has been chosen, as a representative activity of those related to food, which requires control, strength and coordination of the UL. The study is carried out at the Hospital Nacional de Parapléjicos with the collaboration of Occupational Therapy Unit, the Rehabilitation Department, and the Biomechanics and Technical Aids Unit. This effectiveness is measured in terms of functional improvements and in the quality of the UL movements performed.

Detailed description: In the literature, there are several studies of the upper limb applied to ADL. The analysis of complete ADL is related to the clinical objectives of the rehabilitative treatment of the UL. An important part of rehabilitation after neurological injuries consists of training activities aimed at fulfilling a function or objective, in which patients have to move their arms continuously repeating certain movement patterns. This is currently one of the main strategies to promote recovery of upper limb function in people who have suffered a spinal cord injury (SCI) o stroke.

Within the clinical setting, the main motivation in the use of robotic devices and/or exoskeletons for a rehabilitation purpose focuses on the fact that these help therapists in administering repetitive manual therapies to patients during exercises. There is evidence that the amount of therapy patients receive is insufficient. Without creating additional time demands on clinicians, robotic devices can perform the repetitive mechanical aspects of therapy, increasing the amount of therapy that patients receive. On the other hand, the use of robotic devices is closely linked to the use of virtual reality (VR) applications. VR interfaces provide feedback to the patient, increasing their level of motivation and adherence to the task during therapy. In this way, therapies with robotic devices and / or exoskeletons increase the amount of rehabilitation, the level of motivation of the patient, and training oriented to fulfill a function or task. Rehabilitation of patients with robotic device-based therapies in addition to traditional therapies could improve functional outcomes. However, the current evidence in stroke patients suggests that the improvements observed are due to the intensity of the therapy, regardless of whether the administration of rehabilitation is due to robotic devices and/or traditional means.

The main objective of this study is to analyze the effectiveness of the commercial Armeo® Spring system (Hocoma AG, Switzerland) and a Virtual Reality application to repeatedly work the ADL from drinking from a glass, in people with cervical SCI. The ADL of drinking has been chosen, as a representative activity of those related to food, which requires control, strength and coordination of the UL. The study is carried out at the Hospital Nacional de Parapléjicos with the collaboration of Occupational Therapy Unit, the Rehabilitation Department, and the Biomechanics and Technical Aids Unit. This effectiveness is measured in terms of functional improvements and in the quality of the UL movements performed.

The secondary objectives are:

* To validate the applicability of the Virtual Reality developed to work the upper limb during the execution of a complete AVD.
* To know the usability and level of acceptance of this therapy in patients with spinal cord injury and UL functional impairments.
* To quantify the differences between the functional patterns of both groups, intervention and control, by means of objective measures, functional scales and measures of the quality of movement, collected in patient evaluations, before, during and after treatment.
* To determine the influence of the RV and the Armeo Spring exoskeleton on the motor recovery of patients with spinal cord injury and UL impairments.

Eligibility criteria: Inclusion Criteria:

* Cervical lesions above C8, incomplete in the motor aspect or complete with zones of partial motor preservation at least C6, classified according to the ASIA scale.
* Traumatic or non-progressive medical etiology.
* Less than 6 months of injury evolution (subacute).
* Age between 16 and 75 years.
* To have reached the seated posture.
* Be informed and consent to participate in the study.

Exclusion Criteria:

* Unstable orthopaedic injuries such as unconsolidated fractures or with unstable osteosynthesis systems in upper limbs.
* Skin lesions and/or pressure ulcers in the exoskeleton placement area.
* Having joint stiffness and/or severe spasticity.
* Bronchopneumopathy and/or severe heart disease that will require monitoring during exercise.
* Visual problems.
* Cognitive impairment.
* Do not sign the corresponding informed consent.

Primary outcomes:
measure: Clinical scale SCIM
timeFrame: At baseline
measure: Change from baseline Clinical scale SCIM at 10 weeks
timeFrame: At the end of the study (at week 10)
measure: Clinical scale CUE
timeFrame: At baseline
measure: Change from baseline Clinical scale CUE at 10 weeks
timeFrame: At the end of the study (at week 10)
measure: Clinical Scale Jebsen-Taylor Hand Function (JTHF)
timeFrame: At baseline
measure: Change from baseline Clinical Scale Jebsen-Taylor Hand Function (JTHF) at 10 weeks
timeFrame: At the end of the study (at week 10)
measure: Clinical scale Nine Hole Peg Test
timeFrame: At baseline
measure: Change from baseline Clinical scale Nine Hole Peg Test at 10 weeks
timeFrame: At the end of the study (at week 10)
measure: Clinical Scale GRASSP
timeFrame: At baseline
measure: Change from baseline Clinical Scale GRASSP at 10 weeks
timeFrame: At the end of the study (at week 10)
measure: Edinburg Handedness Test
timeFrame: At baseline
measure: Kinematic indices
timeFrame: At baseline
measure: Change from baseline Kinematic indices at 10 weeks
timeFrame: At the end of the study (at week 10)
Secondary outcomes:
measure: Compliance
timeFrame: At the end of the study (at week 10)
measure: QUEST usability scale
timeFrame: At the end of the study (at week 10)
measure: TMS assessment
timeFrame: At baseline
measure: Change from baseline TMS assessment at 10 weeks
timeFrame: At the end of the study (at week 10)
measure: Beck's Depression Inventory
timeFrame: At baseline
measure: Change from baseline Beck's Depression Inventory at 10 weeks
timeFrame: At the end of the study (at week 10)
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: At baseline
measure: Change from baseline Hospital Anxiety and Depression Scale (HADS) at 10 weeks
timeFrame: At the end of the study (at week 10)
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: Hospital Nacional de Parapléjicos
Study officials:
affiliation: Hospital Nacional de Parapléjicos
name: Ana de los Reyes, PhD
role: PRINCIPAL_INVESTIGATOR
References: