NCT03709875

Telerehabilitation in Severe Acquired Brain Injury

Status unknown NA Last updated 18 October 2018

What this trial tests

NA trial testing TR Treatment in Brain Injuries in 40 participants. Status unknown.

Timeline

26 November 2018

Primary endpoint
27 May 2019

28 December 2020

Quick facts

Lead sponsor	IRCCS Centro Neurolesi Bonino Pulejo
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	40
Start date	26 November 2018
Primary completion	27 May 2019
Estimated completion	28 December 2020
Sites	1 location across Italy

Drugs / interventions tested

• TR Treatment

Conditions studied

• Brain Injuries — all drugs for Brain Injuries →
• Stroke — all drugs for Stroke →

Sponsor

IRCCS Centro Neurolesi Bonino Pulejo — full company profile →

Who can join

Adults 18 to 65, any sex, with Brain Injuries or Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Benefits of Telerehabilitation for Patients With Severe Acquired Brain Injury: Promising Results From a Multicenter Randomized Controlled Trial Using Nonimmersive Virtual Reality.
   Calabrò RS, Bonanno M, Torregrossa W, Cacciante L, et al · · 2023 · cited 27× · PMID 37490017 · DOI 10.2196/45458
2. Telerehabilitation in individuals with severe acquired brain injury: Rationale, study design, and methodology.
   Calabrò RS, Bramanti A, Garzon M, Celesti A, et al · · 2018 · cited 23× · PMID 30557976 · DOI 10.1097/md.0000000000013292