Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450717
Status:
COMPLETED
Last Update Posted:
2024-06-28
First Post:
2024-06-05
Brief Title:
Implementation of a Pilot Telerehabilitation Network in Pediatric Patients With Complex Neurodisabilities MedeaNeuroTelerehab-Net MENTENET Study
Sponsor:
IRCCS Eugenio Medea
Organization:
IRCCS Eugenio Medea
Study Overview
Official Title:
Implementation of a Pilot Telerehabilitation Network in Pediatric Patients With Complex Neurodisabilities MedeaNeuroTelerehab-Net MENTENET Study
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot study aims at networking the experience gained in neurorehabilitation of developmental neurodisabilities from the 3 poles of IRCCS Medea Brindisi Bosisio Parini and Conegliano to assess the feasibility of performing home-based telerehabilitation on cognitive and motor aspects through the Khymeia Virtual Reality Rehabilitation System VRRS platform
Detailed Description:
Few studies report the efficacy of telerehabilitation treatments in developmental age The results suggest that it could be a promising tool for neurorehabilitationThe present pilot study aims at networking the experience gained in neurorehabilitation of developmental neurodisabilities from the 3 poles of IRCCS Medea Brindisi Bosisio Parini and Conegliano to evaluate the feasibility of performing home-based TR on cognitive and motor aspects through the Khymeia VRRS platform VRRS represents an innovative system for immersive and non-immersive virtual reality rehabilitation and telerehabilitation
In view of recent developments in Information and Communication Technologies ICT and their applicability to the neurological evaluation and rehabilitation context VRRS instrumentation may represent a suitable methodology to assess the feasibility of a rehabilitation and telerehabilitation protocol for patients with complex neurodisabilities in pediatric age
The present pilot project involves the use of the VRRS technology platform and the use of exercises performed in a 3D virtual and non-3D virtual environment Implementation in the virtual environment of the exercises allows the therapist to set up graduate and modulate the selected exercises in the platform The playful aspects and continuous performance monitoring and evaluation are then a key aspect in the rehabilitation process as they keep the patients motivation high Through Home Tablets delivered to the patient the platform makes possible home telerehabilitation through the proposal of cognitive and motor activities in 2 modes Online in the presence of the therapist and Offline
In order to test the feasibility of cognitive-motor rehabilitation intervention protocols carried out through VRRS 30 patients 10 per research center will be recruited and treated by using the VRRS library exercises The VRRS exercises will be chosen according to the specific rehabilitation needs of each participant
The study is designed as a two-year multicenter prospective clinical-experimental pilot study The project involves the initial small-scale application of a telerehabilitation study protocol to test whether the methodology is appropriate establish its feasibility and derive useful information for sample size calculation for subsequent randomized trials For prospective data collection patients will be consecutively enrolled at participating centers
If the VRRS is confirmed to be a suitable tool for conducting cognitive and motor TR in this clinical population as well the present study may set the stage for future efficacy studies
Other objectives of the study are
to identify within the network telerehabilitation programs aimed at improving cognitive and motor functions in developmental-age individuals with neurodisabilities identifying common modes of intervention
to collect a longitudinal data set through the use of specific assessment batteries on motor cognitive and functional adaptation functions including from the perspective of ICF secondary complications autonomy participation and quality of life As a pilot study conduct initial analyses of the effectiveness of interventions in order to create useful data for sample size calculation for subsequent randomized trials
to provide health policy makers with better scientific evidence on telerehabilitation in order to plan interventions aimed at better utilization and enhancement of these methods
to highlight good practices related to telerehabilitation by proposing a series of evaluations and recommendations aimed at fostering further improvement in the quality of rehabilitation
In view of recent developments in Information and Communication Technologies ICT and their applicability to the neurological evaluation and rehabilitation context VRRS instrumentation may represent a suitable methodology to assess the feasibility of a rehabilitation and telerehabilitation protocol for patients with complex neurodisabilities in pediatric age
The present pilot project involves the use of the VRRS technology platform and the use of exercises performed in a 3D virtual and non-3D virtual environment Implementation in the virtual environment of the exercises allows the therapist to set up graduate and modulate the selected exercises in the platform The playful aspects and continuous performance monitoring and evaluation are then a key aspect in the rehabilitation process as they keep the patients motivation high Through Home Tablets delivered to the patient the platform makes possible home telerehabilitation through the proposal of cognitive and motor activities in 2 modes Online in the presence of the therapist and Offline
In order to test the feasibility of cognitive-motor rehabilitation intervention protocols carried out through VRRS 30 patients 10 per research center will be recruited and treated by using the VRRS library exercises The VRRS exercises will be chosen according to the specific rehabilitation needs of each participant
The study is designed as a two-year multicenter prospective clinical-experimental pilot study The project involves the initial small-scale application of a telerehabilitation study protocol to test whether the methodology is appropriate establish its feasibility and derive useful information for sample size calculation for subsequent randomized trials For prospective data collection patients will be consecutively enrolled at participating centers
If the VRRS is confirmed to be a suitable tool for conducting cognitive and motor TR in this clinical population as well the present study may set the stage for future efficacy studies
Other objectives of the study are
to identify within the network telerehabilitation programs aimed at improving cognitive and motor functions in developmental-age individuals with neurodisabilities identifying common modes of intervention
to collect a longitudinal data set through the use of specific assessment batteries on motor cognitive and functional adaptation functions including from the perspective of ICF secondary complications autonomy participation and quality of life As a pilot study conduct initial analyses of the effectiveness of interventions in order to create useful data for sample size calculation for subsequent randomized trials
to provide health policy makers with better scientific evidence on telerehabilitation in order to plan interventions aimed at better utilization and enhancement of these methods
to highlight good practices related to telerehabilitation by proposing a series of evaluations and recommendations aimed at fostering further improvement in the quality of rehabilitation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None