Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05740605
Status:
RECRUITING
Last Update Posted:
2023-03-06
First Post:
2023-02-02
Brief Title:
Implementation of a HABIT-ILE Intervention at Home for Children With Bilateral Cerebral Palsy
Sponsor:
Université Catholique de Louvain
Organization:
Université Catholique de Louvain
Study Overview
Official Title:
Implementation of a HABIT-ILE at Home Intervention for Children With Bilateral Cerebral Palsy a Non-inferiority Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-03
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:
HABITILEhome
Brief Summary:
Intensive interventions based on the principles of motor skill learning like Hand-Arm Bimanual Therapy Including Lower Extremities HABIT-ILE have demonstrated excellent effectiveness in improving motor function and daily life independence of children with cerebral palsy CP Patients living far from big cities do not have easy access to such interventions usually applied in the form of camps This randomized controlled trial will include 48 children with bilateral CP and aims to test a home version of HABIT-ILE with the use of a specifically designed virtual device and a remote supervision For this purpose two types of two weeks intensive treatment programs will be compared Hand and Arm Bimanual Intensive Therapy Including Lower Extremities at home HABIT-ILE at home and classic HABIT-ILE Moreover this study also aims to assess whether the patients abilities are better with a follow-up at home after two weeks of HABIT-ILE therapy than without follow-up post therapy Four groups will be compared HABIT-ILE at home therapy with a follow-up at home HABIT-ILE at home therapy without follow-up classic HABIT-ILE therapy with a follow-up at home and classic HABIT-ILE therapy without follow-up Children will be assessed at 3 time points before therapy after therapy and 3 months after the start of therapy
Detailed Description:
Cerebral Palsy CP is the most common cause of physical disability in children it occurs in 1 to nearly 4 children in 1000 newborns worldwide This major public health issue caused by abnormal brain development or damage during brain development result in different symptoms that vary from one patient to another Even if all children with CP will develop motor symptoms abnormal movement patterns and posture some of them will also develop non-motor symptoms such as pain 75 intellectual deficits 50 language disorders 25 epilepsy 25 behavioral and sleep disorders 20-25 The consequences of these symptoms are very variable and result in long-term functional deficits in the activities of daily living such as dressing eating going to the bathroom etc To improve these patients autonomy intensive therapies based on motor skill learning MSL have been shown to be especially effective Among these therapies Hand-Arm Bimanual Intensive Therapy including Lower Extremities HABIT-ILE has been developed over the last decade in the MSL-IN laboratory of UCLouvain and has shown impressive improvements in children with CP It is based on an intensive training of bimanual activities with a systematic inclusion of lower limbs and trunk motor control This therapy is given in the form of a rehabilitation camp of at least 50 hours on site Therefore the implementation of a classic HABIT-ILE in day-camp requires a great commitment from the families who must travel to the camp location for two weeks of therapy In addition for patients living far from big cities or unable to travel access to these therapies can be really complex Moreover these camps are applied in a group of 8-12 children Each participant is accompanied by at least one therapist physiotherapist or occupational therapist and sometimes student trained in HABIT-ILE therapy This implies that a HABIT-ILE camp requires minimum 12 trained therapists Nonetheless there is a lack of therapists that makes the implementation of these camps still challenging In addition the health requirements related to COVID-19 make it difficult to implement any kind of therapy and to assess patients progress Therefore this health crisis has highlighted the importance of being able to offer home-based therapy To answer the problematics of pandemic accessibility and of lack of HABIT-ILE therapists the idea of implementing HABIT-ILE at home was born How could we implement MSL principles at home Some of the key components of MSL are intensity shaping of the task with part- task and increasing difficulty goal-oriented therapy positive reinforcement and hands-off voluntary movements by the patients not guided by the therapist To incorporate those principles and ensure the validity of the therapy guidance by a trained HABIT-ILE supervisor is necessary This supervision will be provided through remote telerehabilitation sessions Virtual reality is well suited to implement MSL-IN principles and allows for remote communication with patients Tele-reeducation devices are numerous from classic commercials video game found in stores to devices made for rehabilitation Alone these devices do not allow the implementation of all the principles of motor skill learning but with the supervision of therapists trained in HABIT-ILE supervision this objective could be achieved With the help of new technologies will the HABIT-ILE supervisors be able to implement HABIT-ILE at home in a reliable and standardized way for children with CP aged 6 to 18 This RCT aims to assess if HABIT-ILE at home is not inferior to HABIT-ILE in camp regarding physical abilities functional activities and participation of the participants
Moreover if the maintenance of skills during HABT-ILE camp at 3- and 6-months post-therapy has been proven the question of improving them has not been investigated yet Indeed we know that in order to maintain the skills learned during the HABIT-ILE therapy it is necessary to practice them on a daily basis If a skill is not used it will lead to a cortical reorganization of the motor cortex at the expense of this skill Thus there is a persistent cycle of decreased utilization that leads to unfavorable cortical reorganization that leads to decreased utilization etc It is called learned non-use In order to reduce this phenomenon and thus improve the transfer of the HABIT-ILE skills into the daily life of the children we wonder about the benefit of a post-therapy follow-up Once again the use of tele-rehabilitation can provide us a solution of daily delocalized therapy directly implemented at the patients home and supervised remotely Could the transfer of learned skills be improved with a follow-up at home post therapy In order to answer this question after the two weeks of both HABIT-IL modality we will set up a HABIT-ILE telerehabilitation follow-up for 9 weeks This study therefore also aims to assess if the patients abilities could be potentialize with a follow-up than without a follow-up after two weeks of HABIT-ILE therapy
Moreover if the maintenance of skills during HABT-ILE camp at 3- and 6-months post-therapy has been proven the question of improving them has not been investigated yet Indeed we know that in order to maintain the skills learned during the HABIT-ILE therapy it is necessary to practice them on a daily basis If a skill is not used it will lead to a cortical reorganization of the motor cortex at the expense of this skill Thus there is a persistent cycle of decreased utilization that leads to unfavorable cortical reorganization that leads to decreased utilization etc It is called learned non-use In order to reduce this phenomenon and thus improve the transfer of the HABIT-ILE skills into the daily life of the children we wonder about the benefit of a post-therapy follow-up Once again the use of tele-rehabilitation can provide us a solution of daily delocalized therapy directly implemented at the patients home and supervised remotely Could the transfer of learned skills be improved with a follow-up at home post therapy In order to answer this question after the two weeks of both HABIT-IL modality we will set up a HABIT-ILE telerehabilitation follow-up for 9 weeks This study therefore also aims to assess if the patients abilities could be potentialize with a follow-up than without a follow-up after two weeks of HABIT-ILE therapy
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