Effectiveness Analysis of Armeo Spring Device as a Rehabilitation Treatment in Spinal Cord Injured Patients
Condition: Spinal Cord Injury Cervical
MeSH terms: Spinal Cord Injuries
Study type: Interventional

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.
    

Intervention name(s): Training by means of Armeo Spring device; Current treatment based on conventional therapy; Additional treatment based on conventional therapy
Intervention type(s): Device; Other; Other
Intervention description(s): This patients group receive 40 experimental sessions. Each session is based on 30 min by using Armeo Spring device.; All the patients enrollment in the study receive 30 min of conventional therapy during 40 sessions.; This intevention was added for providing the same amount of therapy than those patients randomly enrolled in the intervention group. So, patients in the control group receive other 30 min of conventional therapy added on current treatment during 40 sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Effectiveness; Rehabilitation; Upper extremity; Spinal Cord Injury cervical; Robotic device