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

Official title

Association of a HABIT-ILE Course and a Home Programme on the Bimanual Performance of Children Aged 3 to 5 Years With Cerebral Palsy: a Multicentre Randomised Controlled Trial of Non-inferiority

Overview

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.

Detailed description

The PARTNERSHIP study will compare, for the first time, a mixed PARTNER camp modality, including a HABIT-ILE camp modality and a home programme modality, with parental coaching, to a reference HABIT-ILE modality.

The children in the PARTNER group will therefore spend 3.5 hours a day for 10 days in HABIT-ILE therapy, plus 1.5 hours a day for 10 days in home activities carried out by the family.

The children in the HABIT-ILE group will have 5 hours of HABIT-ILE therapy per day, the reference modality.

A non-inferiority, mixed-methods, multicentre randomised controlled trial will be conducted to compare the effectiveness of the PARTNER programme with the reference HABIT-ILE programme on the bimanual performance (Assisting Hand Assessment \[AHA\]) of children with unilateral CP aged 3 to 5 years. The secondary aims are to compare the 3-month effectiveness of the programmes on occupational performance, functional skills and upper limb activity levels, as well as families' resources, the parent-child relationship, the quantity and quality of resources available in the home to stimulate the child's motor development, and parental perceptions of their child's disability and their child's abilities (qualitative study). The tertiary aim is to conduct a cost-effectiveness analysis of care consumption in each group up to 6 months after the end of the programmes.

Target recruitment is 66 children (33 in each group) from 3 centres in France. Outcomes will be evaluated before the interventions, immediately after, at 3 months and up to 6 months for the cost-effectiveness analysis. Families in the PARTNER group will receive specific coaching and extensive support to perform the home programme. The coaching will focus on enhancing their resources.

Interventions

• Other Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities
  * 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
• Other Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities
  \- Structured bimanual tasks training, with gradual increase in motor difficulty, requiring increased postural adjustments and the use of the lower extremities.

Primary outcome measures

• Assisting Hand Assessment (AHA) [Time frame: 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 outcome measures (12)

• Canadian Measure of Occupational Performance (COPM) [Time frame: 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) [Time frame: 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 [Time frame: 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) [Time frame: 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) [Time frame: 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)]
• Changes of family resources: The Psychological Empowerment Scale (PES) [Time frame: At the baseline (T0), at the end of the camp (T1: T0+ 21+2 days), and during the follow-up visit (T2: T0+ 90+2days)]
• Changes of family resources: The Parental Stress Inventory (PSI) [Time frame: 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)]
• Home Environment for Motor Development Self-Report (AHEMD-SR) [Time frame: 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)]
• Parent-Child Early Relational Assessment (PCERA) [Time frame: 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)]
• Parental representations: PARTNER programme [Time frame: At the baseline (T0), and during the follow-up visit (T2: T0+ 90±2 days)]
• Cost-effectiveness analysis [Time frame: From baseline (T0) to the end of the camp (T1: T0+ 21±2 days]
• Impact on care consumption [Time frame: From baseline (T0) to 6 months post intervention.]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

France · 1 center

• Fondation ILDYS — Brest

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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 Clinica PMID 37930692

Identifiers

NCT: NCT06963151 · RI2023_001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗