Cerebral Palsy (CP)FACTNCT07889622
Effects and Feasibility of a HABIT-ILE and a Home Program on the Bimanual Performance of Children With Cerebral Palsy
An observational study of Cerebral Palsy (CP), run by Fondation Ildys at 1 site in France.
Trial summary
This single arm double baseline study explored the efficacy and feasibility of the PARTNER program (30h HABIT-ILE + 10h home program) on the functional changes and families' resources of 14 children with unilateral CP aged 24 to 71 months. Read more about this study
- Who is it for?
- Ages 24 to 71 months
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Behavioral
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2022to 1 Sep 2023
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 71 months
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 24 to 71 months (corrected age) with physician-confirmed unilateral cerebral palsy were eligible. Participants were required to demonstrate minimal upper limb function in the affected hand, defined as the ability to grasp a light object and lift it at least 15 cm above a table surface. Cognitive and communicative abilities sufficient to understand instructions and complete all assessments were also required. Children with ataxic CP, uncontrolled epilepsy, or significant visual or auditory deficits likely to interfere with participation were excluded. To ensure treatment stability, children who had received botulinum toxin injections or undergone surgery within the 6 months prior to enrolment, or for whom such procedures were planned during the study period, were also excluded. Family commitment was required, with written informed consent obtained from a parent or legal guardian who agreed to participate consistently throughout the study.
Who may be able to join
- Child with unilateral CP confirmed by a physician
- Child aged between 24 to 71 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.
- Written informed consent obtained from a parent or legal guardian.
- Commitment to having the same parent or guardian participate throughout the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a "PARTNER" Program - Combining an Intensive HABIT-ILE Rehabilitation Program With a Family Empowerment Program Designed to Provide Individualized Support for the Motor Development of Children With Cerebral Palsy at Home - a Pilot Study
This single arm double baseline study explored the efficacy and feasibility of the PARTNER program (30h HABIT-ILE + 10h home program) on the functional changes and families' resources of 14 children with unilateral CP aged 24 to 71 months.
Read the detailed description
This single-arm, double-baseline study evaluated the feasibility and efficacy of a combined 30-hour HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) clinic-based intervention and a 10-hour structured home program for children with unilateral cerebral palsy aged 24 to 71 months yo.
The primary outcome was the PDMS-2, assessing gross and fine motor performance. Secondary outcomes included the Assisting Hand Assessment (AHA) for bimanual performance, the Canadian Occupational Performance Measure (COPM) for functional goals, and family-centered measures: the Psychological Empowerment Scale (PES), the Enabling Practices Scal, and Client Satisfaction Questionnaire (CSQ-8) for global satisfaction.
The clinical rehabilitation protocol included two initial assessments (conducted 14 days apart and prior to the motor intervention) to jointly determine the goals with the family. These assessments were followed by a two-week intervention phase (HABIT-ILE + home-based activities). The post-intervention and three-month follow-up assessments allowed for the sharing of follow-up information with the family and also for the evaluation of the immediate and short-term effects of the intervention. The feasibility of the intervention was assessed using adherence rates (on-site intervention and home program), the three-month retention rate, and family satisfaction.
The scientific evaluation of the data from this clinical protocol aimed to provide preliminary evidence for the combined approach while refining protocols for a future randomized controlled trial.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Behavioral
- 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
- Medical subject headings
- Cerebral Palsy, Nervous System Diseases, Brain Damage, Chronic, Brain Diseases, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BehavioralOther
Structured bimanual tasks training, with gradual increase in motor difficulty, requiring increased postural adjustments and the use of the lower extremities. - Home program with parental coaching
| Study group | Role | What they receive |
|---|---|---|
| PARTNER protocol | Subjects received 30 hours of HABIT-ILE clinic-based intervention 3h/day, 5 days/week and 10 hours of home program 1h/day, 5 day/week. These two procedures were performed concurrently over a 2-week period. Receives: Other: Behavioral |
What is being measured
The primary outcome is the main question the study is designed to answer.
PDMS-2
The primary outcome was the difference in PDMS-2 score changes between the usual care control and PARTNER intervention periods. The PDMS-2 is a standardized, norm-referenced tool assessing motor development in children aged 0-5 years, with demonstrated reliability and responsiveness in young children with cerebral palsy (CP). It includes six subtests evaluating gross and fine motor skills. Raw scores are converted into age-standardized scores to calculate the Total Motor Quotient (TMQ), Fine Motor Quotient (FMQ), and Gross Motor Quotient (GMQ). The TMQ provides an overall measure of motor competence, classified as average (90-110), below average (80-89), poor (70-79), or very poor (35-69). FMQ and GMQ assess fine and gross motor performance relative to age-matched peers. In children aged 27-64 months with CP, responsiveness ranged from 1.7 to 2.3 across the three composite scores.
Measured: pre-camp, two weeks post-camp, 3 months follow-up
Secondary outcomes (4)
AHA
The Assisting Hand Assessment (AHA) is a valid and reliable measure of bimanual performance, assessing the contribution of the most affected hand. Developed for children with unilateral cerebral palsy (CP) aged 18 months to 12 years, it is the gold standard in clinical practice and research. Raw scores are converted to a 0-100 logit scale using a Rasch model and conversion table. Its Smallest Detectable Difference (SDD) is 3.89.
Measured: pre-camp, two weeks post-camp, 3 months follow-up
Feasibility
Protocol feasibility will be assessed using a traffic-light system based on predefined criteria (Davis et al.). (1) On-site intervention completion: green, ≥90% of children complete ≥90% of the 30 hours; amber, 70-89% complete ≥90%, or ≥90% complete 70-89%; red, <70% complete ≤70%. (2) Home intervention completion: green, ≥90% of families complete >90% of the 10 hours; amber, 70-89% complete ≥90%, or ≥90% complete 70-89%; red, <70% complete ≤70%. (3) Three-month retention: green, ≥90% return; amber, 70-89%; red, <70%. (4) Family satisfaction: green, ≥90% of families report ≥90% satisfaction; amber, 70-89%; red, ≤70%, measured using the validated 8-item Client Satisfaction Questionnaire (CSQ-8). Feasibility will be confirmed if all criteria are green; amber results will require protocol adjustments, while any red result will prevent progression to the main trial.
Measured: During the camp, 3 months follow up
The empowerment of parents
Parental empowerment refers to parents' ability to act confidently, take control and advocate for their child's needs within healthcare and support systems to improve family quality of life. The Psychological Empowerment Scale (PES) measures parents' perceived empowerment; the overall score will be used. We hypothesize that active participation in the PARTNER program, through problem-solving and support for children's motor development, will strengthen family empowerment.
Parental enabling refers to professionals' practices that promote parents' active involvement, informed decision-making and skill development in their child's care. Unlike empowerment, which reflects parents' internal sense of control and agency, enabling concerns the external, professional-driven conditions that facilitate engagement. The Enabling Practices Scale (EPS) assesses parents' perceptions of these practices.
Measured: pre-camp, 3 months follow-up.
COPM
The Canadian Occupational Performance Measure (COPM) is a semi-structured interview used to define therapeutic goals and assess children's performance and parents' satisfaction. Following Cuzick et al., "paid/unpaid work" and "household management" were excluded. Parents identified five priority needs and rated their child's performance (COPMp) and their satisfaction (COPMs). Although the minimal clinically important difference (MCID) is commonly set at 2 points, Cuzick et al. reported a mean overall score change of 2.85 points (median 2.84).
Measured: pre-camp, two weeks post-camp, 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Mar 2022
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ildys
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Angers Les Capucins, SMR Pédiatrique, IMT Atlantique Brest, INSERM UMR 1101
- Responsible party
- Sponsor
- Investigators
- Rodolphe BAILLY, Principal investigator, Fondation Ildys
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889622
- Sponsor's protocol ID
- RI2022_001
- Acronym
- FACT
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37930692Bonden 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.
PubMed 38083836Holmefur 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.
PubMed 19841839Kang 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.
PubMed 32491226Karstad 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.
PubMed 36615077Krumlinde-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.
PubMed 17376135Laister 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.
PubMed 34950076Tedla 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.
PubMed 38050486