NCT04362800: MOOV

Functional Effects and Impact on Motor Neuronal Activity of Early and Intensive Motrice (Hand and Arm Bimanual Intensive Therapy Including Lower Extremities: HABIT-ILE) Reeducation in Children With Pre-school Bilateral Cerebral Palsy

Completed NA Last updated 21 December 2021

What this trial tests

NA trial testing MRI in Cerebral Palsy in 36 participants. Completed in 17 September 2021.

Timeline

19 January 2021

Primary endpoint
17 September 2021

17 September 2021

Quick facts

Lead sponsor	University Hospital, Brest
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	36
Start date	19 January 2021
Primary completion	17 September 2021
Estimated completion	17 September 2021
Sites	2 locations across France

Drugs / interventions tested

• MRI — full drug profile →
• Electro-Encephalography-High Density
• 3D and EMG analysis
• care and classic activities

Conditions studied

• Cerebral Palsy — all drugs for Cerebral Palsy →

Sponsor

University Hospital, Brest

Who can join

Adults 12 Months to 59 Months, any sex, with Cerebral Palsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

One of the urgent priorities in the field of pediatric neuro-rehabilitation is the development of efficient early motor interventions for children with cerebral palsy (CP). Animal studies suggest that early intensive interventions are likely to have a significant impact on the organization of the brain and corticospinal tracts, reducing motor impairments and their medium and long-term consequences in children with cerebral palsy. Although most of the growth, development and cortical organization takes place in the time course of the first 2 years of life, most studies investigating the effectiveness of intensive rehabilitation and associated neurophysiological mechanisms have been conducted in school-aged children (\> 6 years). In addition, the vast majority of these studies were conducted in children with unilateral CP, while the bilateral form of the pathology has the highest prevalence. It is therefore a priority to investigate the effectiveness of early interventions on the overall motor function of children with CP, especially in children with bilateral form of CP.

Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) makes it possible to apply the concepts of structured motor learning and intensive treatment to both the upper limbs and the lower limbs and demonstrated improvements at both levels in school-aged children with unilateral CP and bilateral and then at all three International Classification of Functioning and Disability levels. The principles and content of HABIT-ILE can be applied to pre-school children and this method is promising for early neuro-rehabilitation.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.