About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Parallel
Treatments tested in this trial
Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities
Other intervention* 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
Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities
Other intervention\- Structured bimanual tasks training, with gradual increase in motor difficulty, requiring increased postural adjustments and the use of the lower extremities.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Canadian Measure of Occupational Performance (COPM)
The Canadian Measure of Occupational Performance (COPM) will be used to define therapeutic goals, and to quantify the change in the child's performance and the parents' level of satisfaction for each functional goal. Using the COPM, the therapist conducts a semi-structured interview with the child's parent to identify difficulties in self-care, productivity, and leisure. The parent rates the importance of each indetified issue(1-10) and selects five priorities. For each, they rate their child's performance and their satisfaction with that performance (1-10, Higher ratings indicate greater importance, performance, and satisfaction). Average scores (out of 10) are calculated for performace and satisfaction. A change of two points or more is considered clinically significant. For this secondary outcome, the assumption is a maximum non-inferiority of 10% (T2-T0), ie, 0.4 points on average for the COPM, based on the results of Arenada et al..
Pediatric Evaluation of Disability Inventory Computer Adaptative Test (PEDI-CAT)
The Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) will measure the change in functional skills in the domains of daily activities and mobility. These reliable questionnaires are used in clinical practice and research to determine changes in activity and participation in children with CP. These reliable questionnaires are used in clinical practice and research to determine changes in activity and participation in children with CP. The minimal score of PEDI CAT is 20 and the maximum 80, a higher score translates to higher function functional ability. For this secondary outcome, the assumption is a maximum non-inferiority of 10% (T2-T0), ie, 0.2 points for PEDI-CAT, based on the results of Arenada et al..
Gross motor activity and upper limb activity
Gross motor activity (whole-body movements such as walking, cycling or jumping) and upper limb activity (movements of the arms, hands, and fingers, such as reaching, grasping or manipulating objects) will be measured using inertial sensors worn on each wrist and the trunk during the entire intervention time (35h+15h for the PARTNER group, 50h for the HABIT-ILE group). The main outcome will be the percentage of time spent performing movement during the sessions. The amount of activity performed at home out with sessions will also be measured in both groups.
Changes of family resources: World health organization quality of life - Bref (WHOQOL-Bref)
To complete the questionnaire and participate in the semi-structured interviews, families will be asked to designate the child's main carer, who will agree to participate in the entire study and complete the questionnaires and interviews alone. The WHOQOL-Bref will measure parents' perceptions of their quality of life. This scale is derived from the WHOQOL-100 developed by the WHO (1995). It measures peopol's perception of their quality of life. The scale comprises 26 items divided into four areas: physical health, physiological health, social relationships end the environment. A hign score indicates a good quality of life, while a low score indicates a poorer quality of life. The 26 items are rated on a 5-point Likert scale (scores from 1 to 5). It is possible to obtain a score in each of the 4 domains (average score). These domain scores must be multiplied by 4 to be comparable with the WHOQOL-100. Two items can be analysed separately.
Sponsors and contacts
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Fondation Ildys
Lead sponsor
University Hospital, Angers
Collaborator
University of Rennes 2
Collaborator
Claude Bernard University
Collaborator
IMT Atlantique Brest
Collaborator
INSERM UMR 1101
Collaborator
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