Telerehabilitation for Post-stroke Patients

NCT04413240 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-05-23

No results posted yet for this study

Summary

In the last few years, there has been an increasing shift towards outpatients setting in the care of patients with stroke. Unfortunately, this led to a high percentage of discharged patients who did not receive an adequate amount of rehabilitation, because of some non-clinical factors, such as resource availability, geographical location, age, and personal wealth. To date, there is growing evidence about the role of telerehabilitation as an effective method to deliver rehabilitative treatments to homebound subjects with no moving of therapists or patients. However, the most appropriate organizational models regarding Health Technology Assessment in telerehabilitation procedures still object of debate. On these bases, the aim of this project is to investigate the feasibility and effectiveness of multi-domains telerehabilitation procedures in stroke patients in order to supply the National Health Service with some useful information about the use of telerehabilitation in clinical practice of stroke rehabilitation.

Conditions

  • Stroke Sequelae

Interventions

DEVICE

Telerehabilitation

* VRRS is a medical device to perform cognitive telerehabilitation and home speech therapy in online or offline mode. * K-Wand is an additional device to VRRS for motor telerehabilitation of the upper limb and trunk. It works with a set of motion sensors through light recognition technology. * Khymu is a set of sensors added to the VRRS used to carry out motor telerehabilitation activities of the lower limb. The use in combination with the K-Wand is able to allow "full-body" motor telerehabilitation. Patients will have at their home a special workstation connected to the internet. The same equipment will also be present in the reference structure. Only the online telerehabilitation mode will be used, including an audio and video teleconference. The rehabilitator will be able to remotely control the patient's system. The patient, will see on his screen the exercises to be performed, their realization and the results achieved.

OTHER

Conventional rehabilitation

It is not possible a priori to precisely define the instruments that will be used during rehabilitation management. The telerehabilitation or conventional treatment methods (type of therapeutic exercise, modality of cognitive stimulation and/or taking care of speech therapy) will be determined for each patient on the basis of the needs emerging from the physiatric examination performed at T0, defined according to the Individual Rehabilitation Project and applied according to each Rehabilitation Program (motor, cognitive and/or speech therapy) periodically updated.

Sponsors & Collaborators

  • IRCCS San Camillo, Venezia, Italy

    collaborator OTHER
  • Istituto Superiore di Sanità

    collaborator OTHER
  • Universita di Verona

    lead OTHER

Principal Investigators

  • Nicola Smania, MD · Universita di Verona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2023-05-31
Completion
2023-08-31

Countries

  • Italy

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 NCT04413240 on ClinicalTrials.gov