Association of a HABIT-ILE Course and a Home Programme on the Bimanual Performance of Children With Cerebral Palsy

NCT06963151 | Not Yet Recruiting

• 1 other identifier: RI2023_001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This non-inferiority, mixed-methods, multicentre randomised controlled trial will compare the effects of functional changes and families' resources at 3 months of the PARTNER programme (35h HABIT-ILE + 15h home programme) with the reference HABIT-ILE programme (50h) on the bimanual performance (Assisting Hand Assessment \[AHA\]) of 66 children with unilateral CP aged 3 to 5 years.

Conditions

Cerebral Palsy

Keywords

HABIT-ILE; Intensive motor therapy; Motor skill learning; Parental Coaching; Children; Additional Relavant MeSH Terms; Nervous System Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Assisting Hand Assessment (AHA)

  The Assisting Hand Assessment (AHA) is a valid tool to assess children's ability to perform bimanual tasks, focusing on the functional use of the impaired hand. Its validity, reliability and responsiveness have been demonstrated, and it is regularly used in studies of children with unilateral CP. The raw AHA scores (min: 22 to max: 88) will be covered to a logit scale from 0 to 100 in order to obtain an interval scale, a proprety that the raw scores do not have. The conversion to this scale is based on a Rasch model. An increase in the AHA score indicates an improvement in the child's hability to perform bimanual taks. This study falls into the "Balanced Advantages" model of non-inferiority study designs. In this model, it is common to accept an inferiority level of 10 to 50% of the experimental treatment compared with the reference treatment. For this study, we set the accepted inferiority at -10% of the known values for the reference HABIT-ILE treatment; approximately 5 points.

  At the baseline (T0), at the end of the camp (T1: T0 + 21 + 2 days), and during the follow-up visit (T2: T0 + 90+2 days)

Secondary Outcomes (12)

• Canadian Measure of Occupational Performance (COPM)

  At the baseline (T0), at the end of the camp (T1: T0+ 21+2 days), and during the follow-up visit (T2: T0+ 90+2 days)

• Pediatric Evaluation of Disability Inventory Computer Adaptative Test (PEDI-CAT)

  At the baseline (T0), at the end of the camp (T1: T0+ 21+2 days), and during the follow-up visit (T2: T0 +90+2 days)

• Gross motor activity and upper limb activity

  4 days at home before T0, during the camp, 4days at home before T2

• Changes of family resources: World health organization quality of life - Bref (WHOQOL-Bref)

  At the baseline (T0), at the end of the camp (T1: T0+ 21+2 days), and during the follow-up visit (T2: T0+ 90+2 days)

• Changes of family resources: The Enabling Practice Scale (EPS)

  At the baseline (T0), at the end of the camp (T1: T0+ 21+2 days), and during the follo-up visit (T2: T0+90+2 days)

Study Arms (2)

PARTNER

EXPERIMENTAL

Subjects will receive 35 hours of HABIT-ILE as camp format 3,5h/day, 5 days/week and 15 hours of home programme 1,5h/day, 5 day/week. These two procedures will be carried out concurrently over a 2-week period.

Other: Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities

HABIT-ILE

EXPERIMENTAL

Subjects will receive 50 hours of HABIT-ILE as camp format 5h/day, 5 days/week for two weeks.

Other: Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities

Interventions

Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities OTHER

* Structured bimanual tasks training, with gradual increase in motor difficulty, requiring increased postural adjustments and the use of the lower extremities. * Home programme with parental coaching

PARTNER

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child with unilateral CP confirmed by a physician
• Child aged between 3 years and 5 years 11 months (corrected age) at study entry
• Ability to grasp a light object and lift it ≥15cm above the table using the affected hand.
• Ability to understand instructions and complete all assessments.
• Matched with another child based on age (± 3 months), CP aetiology, and Manual Ability Classification System (MACS) level.
• Written informed consent obtained from a parent or legal guardian.
• Commitment to having the same parent or guardian participate throughout the study.

You may not qualify if:

• Diagnosis of ataxic CP.
• Uncontrolled epilepsy.
• History of botulinum toxin injection or surgery within 6 months of study entry or scheduled within 3 months of the intervention (ie, during the study period).
• Visual or auditory deficits that could interfere with participation in the study.
• Significant cognitive or behavioural disorder limiting the ability to follow instructions, as reported in discussions with the family, therapists and/or during a prior assessment

Sponsors & Collaborators

• Fondation Ildys: lead
• University Hospital, Angers: collaborator
• LP3C, University of Rennes 2: collaborator
• Claude Bernard University: collaborator
• IMT Atlantique Brest: collaborator
• INSERM UMR 1101: collaborator

Study Sites (1)

Fondation ILDYS

Brest, France, 29218, France

Location

Related Publications (9)

• Tedla JS, Asiri F, Reddy RS, Gular K, Kakaraparthi VN, Sangadala DR, Dixit S, Alamri AM, Narne VK, Alasmari RAM, Dhafer OA, Al Shamer MA. Caregiver's Quality of Life Among Children with Cerebral Palsy in the Kingdom of Saudi Arabia, and Various Influencing Factors: A Single Cohort Study. J Multidiscip Healthc. 2023 Nov 29;16:3705-3714. doi: 10.2147/JMDH.S440190. eCollection 2023.

  PMID: 38050486 BACKGROUND

• Laister D, Vivanti G, Marschik PB, Fellinger J, Holzinger D. Enhancement of Social Communication Behaviors in Young Children With Autism Affects Maternal Stress. Front Psychiatry. 2021 Dec 7;12:797148. doi: 10.3389/fpsyt.2021.797148. eCollection 2021.

  PMID: 34950076 BACKGROUND

• Krumlinde-Sundholm L, Holmefur M, Kottorp A, Eliasson AC. The Assisting Hand Assessment: current evidence of validity, reliability, and responsiveness to change. Dev Med Child Neurol. 2007 Apr;49(4):259-64. doi: 10.1111/j.1469-8749.2007.00259.x.

  PMID: 17376135 BACKGROUND

• Karstad SB, Bjorseth A, Lindstedt J, Brenne AS, Steihaug H, Elvrum AG. Parental Coping, Representations, and Interactions with Their Infants at High Risk of Cerebral Palsy. J Clin Med. 2022 Dec 29;12(1):277. doi: 10.3390/jcm12010277.

  PMID: 36615077 BACKGROUND

• Kang M, Smith E, Goldsmith CH, Switzer L, Rosenbaum P, Wright FV, Fehlings D. Documenting change with the Canadian Occupational Performance Measure for children with cerebral palsy. Dev Med Child Neurol. 2020 Oct;62(10):1154-1160. doi: 10.1111/dmcn.14569. Epub 2020 Jun 3.

  PMID: 32491226 BACKGROUND

• Holmefur M, Aarts P, Hoare B, Krumlinde-Sundholm L. Test-retest and alternate forms reliability of the assisting hand assessment. J Rehabil Med. 2009 Nov;41(11):886-91. doi: 10.2340/16501977-0448.

  PMID: 19841839 BACKGROUND

• Bonden H, Jahnsen RB, Klevberg GL. Self-care and hand function in preschool children with unilateral or bilateral cerebral palsy: A cross-sectional study. Child Care Health Dev. 2024 Jan;50(1):e13208. doi: 10.1111/cch.13208. Epub 2023 Dec 11.

  PMID: 38083836 BACKGROUND

• Araneda R, Ebner-Karestinos D, Paradis J, Klocker A, Saussez G, Demas J, Bailly R, Bouvier S, Carton de Tournai A, Herman E, Souki A, Le Gal G, Nowak E, Sizonenko SV, Newman CJ, Dinomais M, Riquelme I, Guzzetta A, Brochard S, Bleyenheuft Y. Changes Induced by Early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities in Young Children With Unilateral Cerebral Palsy: A Randomized Clinical Trial. JAMA Pediatr. 2024 Jan 1;178(1):19-28. doi: 10.1001/jamapediatrics.2023.4809.

  PMID: 37930692 BACKGROUND

• Demas J, Jacquemot D, Bouvier S, Goff ML, Carcreff L, Dinomais M, Vuillerot C, Brochard S, Dubois A, Bailly R. Is PARTNER, a hybrid HABIT-ILE programme with parent coaching, as effective as standard HABIT-ILE in children with cerebral palsy aged 3-5? A protocol for a multicentre, randomised controlled trial. BMJ Open. 2025 Sep 16;15(9):e105076. doi: 10.1136/bmjopen-2025-105076.

  PMID: 40962347 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rodolphe BAILLY

  Fondation Ildys

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manon LE GOFF

CONTACT

0298028308; manon.legoff@ildys.org

Matthieu PICHELIN

CONTACT

0298293915; matthieu.pichelin@ildys.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: May 8, 2025
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)