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Effectiveness Analysis of Armeo Spring Device as a Rehabilitation Treatment in Spinal Cord Injured Patients

NCT04383873 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2022-04-18

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injury Cervical

Interventions

DEVICE

Training by means of Armeo Spring device

This patients group receive 40 experimental sessions. Each session is based on 30 min by using Armeo Spring device.

OTHER

Current treatment based on conventional therapy

All the patients enrollment in the study receive 30 min of conventional therapy during 40 sessions.

OTHER

Additional treatment based on conventional therapy

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.

Sponsors & Collaborators

  • Hospital Nacional de Parapléjicos de Toledo

    lead OTHER

Principal Investigators

  • Ana de los Reyes, PhD · Hospital Nacional de Parapléjicos

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-18
Primary Completion
2021-11-30
Completion
2021-12-28

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04383873 on ClinicalTrials.gov