Implementation of a New Motor Skill Learning Therapeutic Device in Children With Cerebral Palsy Rehabilitation

NCT03930836 | Completed

• 1 other identifier: B403201316810c
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Study of the efficiency of a new interactive interface to apply all the therapeutic principles of motor skill learning used in high dosage intensive interventions. Investigation of its effects on motor, functional and neuroplastic changes in children after high and low dosage intensive interventions using or not the interface.

Conditions

Cerebral Palsy

Keywords

motor function; motor skill learning

Outcome Measures

Primary Outcomes (2)

• Change from baseline Assisting Hand Assessments score at 1 week post-camp

  The Assisting Hand Assessment has been developped to measure and describe the efficacy of use of the affected hand of children with unilateral cerebral palsy bimanual activity performance. This is a standardized criterion-referenced test. It is conducted as a recorded semi-structured play session using specific objects usually used in a bimanual manner. With twenty-two test items, the child's performance is measured and obtain a sum score measure and a scaled score (percent scale).

  pre-camp (1 week before), post-camp (1 week after), 3 months follow-up

• Change from baseline 6 Minutes Walking Test score at 1 week post-camp

  Measurement developped to assess the exercise tolerance and walking abilities by asking the patient to walk as much as possible during 6 minutes in a 30 meters long corridor

  pre-camp (1 week before), post-camp (1 week after), 3 months follow-up

Secondary Outcomes (9)

• Change from baseline Box and Blocks test score at 1 week post-camp

  pre-camp (1 week before), post-camp (1 week after), 3 months follow-up

• Change from baseline Jebsen-Taylor Test of Hand Function score at 1 week post-camp

  pre-camp (1 week before), post-camp (1 week after), 3 months follow-up

• Change from baseline Modified Cooper test at 1 week post-camp

  pre-camp (1 week before), post-camp (1 week after), 3 months follow-up

• Change from baseline ABILHAND-Kids questionnaire score at 1 week post-camp

  pre-camp (1 week before), post-camp (1 week after), 3 months follow-up

• Change from baseline ACTIVLIM-CP questionnaire score at 1 week post-camp

  pre-camp (1 week before), post-camp (1 week after), 3 months follow-up

Study Arms (2)

control group

ACTIVE COMPARATOR

high/low dosage intervention, intensive or not (motor function rehabilitation)

Behavioral: Hand Arm Bimanual Intensive Therapy Including Lower Extremities; Behavioral: Conventional physical and occupational therapy

interface group

EXPERIMENTAL

high/low dosage intensive intervention using the interactive interface (motor function rehabilitation)

Behavioral: Hand Arm Bimanual Intensive Therapy Including Lower Extremities

Interventions

Hand Arm Bimanual Intensive Therapy Including Lower Extremities BEHAVIORAL

Intensive intervention focusing on a constant bimanual coordination with a lower extremities and trunk control stimulation during play and functional activities. 50% of therapeutic time will be performed using the new interactive interface

control group; interface group

Conventional physical and occupational therapy BEHAVIORAL

Conventional therapy (physical and occupational therapy) is mainly based on neurodevelopmental therapeutic principles. 50% of therapeutic time will be performed using the new interactive interface

control group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• diagnosis of unilateral cerebral palsy
• MACS level I, II or III
• GMFCS level I, II, III

You may not qualify if:

• unstable seizure
• cognitive deficit that prevent understanding of simple games
• botulinic toxin injection, surgery, or another unusual intervention in the 6 months preceding the study and for the duration of the study

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

Institute of Neuroscience, Université catholique de Louvain

Brussels, 1200, Belgium

Location

Related Publications (1)

• Saussez G, Bailly R, Araneda R, Paradis J, Ebner-Karestinos D, Klocker A, Sogbossi ES, Riquelme I, Brochard S, Bleyenheuft Y. Efficacy of integrating a semi-immersive virtual device in the HABIT-ILE intervention for children with unilateral cerebral palsy: a non-inferiority randomized controlled trial. J Neuroeng Rehabil. 2023 Jul 29;20(1):98. doi: 10.1186/s12984-023-01218-4.

  PMID: 37516873 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Design

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

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: April 29, 2019
• Study Start: June 14, 2018
• Primary Completion: June 20, 2020
• Study Completion: July 15, 2020
• Last Updated: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)