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Clinical Trials/NCT03709875
NCT03709875
Unknown
Not Applicable

A Cost-effective Analysis of Telerehabilitation in Patients With Severe Acquired Brain Injury

IRCCS Centro Neurolesi "Bonino-Pulejo"1 site in 1 country40 target enrollmentNovember 26, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Injuries
Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"
Enrollment
40
Locations
1
Primary Endpoint
WHO Disability Assessment schedule
Last Updated
7 years ago

Overview

Brief Summary

We will investigate the use of TR, based on advanced Information and Communication Technology (ICT) solutions, taking into account that the supervision of rehabilitation at home will be enriched with the counselling and vital parameters monitoring. The aim of the study is to evaluate that TR is at least non-inferior in comparison with the same amount of usual territorial rehabilitative physical treatments (UTRT), taking into account patients' functional recovery, psychological well-being, caregiver burden, and healthcare costs. The enrolled patients will be balanced for pathology and randomized in two groups, performing TR (G1) or standard rehabilitation training (G2), respectively, according to a pc-generated random assignment.TR will be delivered by means of an advanced video-conferencing system, whereas the patient will be provided with low-cost monitoring devices, able to collect data about his/her health status and QoL. In both the groups each treatment (either cognitive or motor, or both as per patient functional status) will last about one hour a day, five days/week, for 12 weeks. Two structured telephone interviews will be administered to the patients (when possible) and/or their caregivers, and to all the healthcare professionals involved in the patient management, one week after the beginning and at the end of the TR.

Registry
clinicaltrials.gov
Start Date
November 26, 2018
End Date
December 28, 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rocco Salvatore Calabrò

Professor

IRCCS Centro Neurolesi "Bonino-Pulejo"

Eligibility Criteria

Inclusion Criteria

  • age range 18 to 65 years; diagnosis of SABI; availability at home internet connection.

Exclusion Criteria

  • severe cognitive and behavioral impairments, cardio-respiratory instability or other medical illness potentially interfering with the treatment, severe limb spasticity, high-risk of spontaneous fracture, substance abuse.

Outcomes

Primary Outcomes

WHO Disability Assessment schedule

Time Frame: 3 months

This generic assessment instrument for health and disability may be considered a tool to produce standardized disability levels and profiles. It is applicable across cultures, in all adult populations, and is directly linked at the level of the concepts to the International Classification of Functioning, Disability and Health (ICF).

Montreal Cognitive assessment

Time Frame: 3 months

he Montreal Cognitive Assessment (MoCA) is a widely used screening assessment for detecting cognitive impairment.he MoCA test is a one-page 30-point test administered in approximately 10 minutes.

Secondary Outcomes

  • Fugl- Meyer for Upper limb(3 months)

Study Sites (1)

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