Telerehabilitation in Severe Acquired Brain Injury

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03709875
• Other study ID #: 08/2018
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 26, 2018
• Est. completion date: December 28, 2020

Study information

• Verified date: October 2018
• Source: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Contact: Rocco S Calabrò, MD, PhD
• Phone: +3909060128166
• Email: salbro77[@]tiscali.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 28, 2020
• Est. primary completion date: May 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Stroke
• Wounds and Injuries

Intervention

Device:
• TR Treatment
A virtual reality based system, consisting of two PC-based workstations, located at the patient's home and at the rehabilitation center, will be used. For the motor treatments the patient has to move the real end effector, following the trajectory of the corresponding virtual task displayed on his computer screen. The speech (mainly lexical based) and cognitive (attention focused) exercises will be delivered from the two Research Institutes to the patient's home. During the treatment at home, the patients will use wearable monitoring devices to monitor their status (speed, heart rate, respiratory rate, training load and single-lead ECG in real-time) and to provide real-time feedback during exercises.

Locations

Country	Name	City	State
Italy	IRCCS Centro Neurolesi Bonino-Pulejo"	Messina

Sponsors (3)

Lead Sponsor	Collaborator
IRCCS Centro Neurolesi "Bonino-Pulejo"	IRCCS San Camillo, Venezia, Italy, University of Messina

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WHO Disability Assessment schedule	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).	3 months
Primary	Montreal Cognitive assessment	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.	3 months
Secondary	Fugl- Meyer for Upper limb	The Fugl-Meyer Upper Extremity (FMUE) Scale1 is a widely used and highly recommended stroke-specific, performance-based measure of impairment. It is designed to assess reflex activity, movement control and muscle strength in the upper extremity of people with post-stroke hemiplegia. It has been extensively used as an outcome measure in rehabilitation trials and to record post-stroke recovery.	3 months