Telerehabilitation in Severe Acquired Brain Injury

NCT03709875 | Unknown DMC

• 1 other identifier: 08/2018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries; Stroke

Keywords

Telerehabilitation; Motor outcomes; Cognitive dysfunction

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Fugl- Meyer for Upper limb

  3 months

Study Arms (2)

TR Treatment

EXPERIMENTAL

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

Conventional Treatment

OTHER

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

Interventions

TR Treatment DEVICE

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; TR Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead
• IRCCS San Camillo, Venezia, Italy: collaborator
• University of Messina: collaborator

Study Sites (1)

IRCCS Centro Neurolesi Bonino-Pulejo"

Messina, 98123, Italy

Location

Related Publications (1)

• Calabro RS, Bonanno M, Torregrossa W, Cacciante L, Celesti A, Rifici C, Tonin P, De Luca R, Quartarone A. Benefits of Telerehabilitation for Patients With Severe Acquired Brain Injury: Promising Results From a Multicenter Randomized Controlled Trial Using Nonimmersive Virtual Reality. J Med Internet Res. 2023 Aug 21;25:e45458. doi: 10.2196/45458.

  PMID: 37490017 DERIVED

MeSH Terms

Conditions

Brain Injuries; Stroke; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Rocco S Calabrò, PhD

  IRCCS Centro Neurolesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rocco S Calabrò, MD, PhD

CONTACT

+3909060128166; salbro77@tiscali.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: multi-center, prospective, parallel design, single-blind trial

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 17, 2018
• Study Start: November 26, 2018
• Primary Completion: May 27, 2019
• Study Completion: December 28, 2020
• Last Updated: October 18, 2018

Record last verified: 2018-10

Locations

IT (1)