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Telerehabilitation in Severe Acquired Brain Injury

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ClinicalTrials.gov Identifier: NCT03709875
Recruitment Status : Not yet recruiting
First Posted : October 17, 2018
Last Update Posted : October 18, 2018
Sponsor:
Collaborators:
IRCCS San Camillo, Venezia, Italy
University of Messina
Information provided by (Responsible Party):
Rocco Salvatore Calabrò, IRCCS Centro Neurolesi "Bonino-Pulejo"

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.

Condition or disease Intervention/treatment Phase
Brain Injuries Stroke Device: TR Treatment Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: multi-center, prospective, parallel design, single-blind trial
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Cost-effective Analysis of Telerehabilitation in Patients With Severe Acquired Brain Injury
Estimated Study Start Date : November 26, 2018
Estimated Primary Completion Date : May 27, 2019
Estimated Study Completion Date : December 28, 2020

Arm Intervention/treatment
Experimental: TR Treatment
TR will be delivered by means of an advanced video-conferencing system, and patients will be provided with low-cost monitoring devices, able to collect data about the health status and QoL. All treatments from remote are based on scheduled videoconferences between the patient's home and the Clinical Units, and therapists can control and modify the exercises. 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 and cognitive exercises will be delivered from the two Research Institutes to the patient's home.
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.

Conventional Treatment
In this group patients will be treated with conventional physiotherapy and speech training, adjusted in reason of the clinical needs, as usually. Treatments for motor limbs activity will be focused on functional active-assistive and active exercises. Conventional "paper and pencil" training will be used to improve cognitive function.
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.




Primary Outcome Measures :
  1. 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).

  2. 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 Outcome Measures :
  1. Fugl- Meyer for Upper limb [ Time Frame: 3 months ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709875


Contacts
Contact: Rocco S Calabrò, MD, PhD +3909060128166 salbro77@tiscali.it

Locations
Italy
IRCCS Centro Neurolesi Bonino-Pulejo"
Messina, Italy, 98123
Sponsors and Collaborators
IRCCS Centro Neurolesi "Bonino-Pulejo"
IRCCS San Camillo, Venezia, Italy
University of Messina
Investigators
Principal Investigator: Rocco S Calabrò, PhD IRCCS Centro Neurolesi

Responsible Party: Rocco Salvatore Calabrò, Professor, IRCCS Centro Neurolesi "Bonino-Pulejo"
ClinicalTrials.gov Identifier: NCT03709875     History of Changes
Other Study ID Numbers: 08/2018
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Rocco Salvatore Calabrò, IRCCS Centro Neurolesi "Bonino-Pulejo":
Telerehabilitation
Motor outcomes
Cognitive dysfunction

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System