Implicit and explicit home-based training programs for young children with cerebral palsy: process evaluation and effectiveness on bimanual performance and parental stress
- Conditions
- spasticityunilateral Cerebral Palsy10010335
- Registration Number
- NL-OMON44919
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 24
In order to be eligible to participate in this study, a child must meet all of the following criteria: 1) clinically confirmed diagnosis of spastic CP based on published diagnostic criteria (either unilateral or extreme asymmetric bilateral), 2) being aged 2 through 7 years at the time of inclusion, 3) Manual Ability Classification System (MACS) level I-III, and 4) Gross Motor Function Classification System (GMFCS) level I-III.
A parents-child triade who meets any of the following criteria will be excluded from participation in this study: 1) surgery or other medical interventions that may affect motor function during the study or within 9 months prior to the study, 2) participation in intensive therapy programs focusing on the upper limbs (e.g. Piratengroep) during the study, 3) inability of parents to respond to interviews and questionnaires in Dutch, 4) expected inability of parents to adhere to the home-based training protocol, 5) co-morbidity affecting arm-hand function, and 6) other indications to withhold the treatment as described.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Process evaluation:<br /><br>fidelity (quality), dose delivered (completeness), dose received (exposure and<br /><br>satisfaction), recruitment and context.<br /><br><br /><br>Effects:<br /><br>Change in performance of predetermined, individual treatment goals, focused on<br /><br>bimanual daily life activities (child) and therapy-related stress (parents).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Effects:<br /><br>Bimanual performance (child)<br /><br>Performance of predetermined, individual rehabilitation goals (child)<br /><br>Satisfaction of the parents of the performance of predetermined, individual<br /><br>rehabilitation goals (child)<br /><br>Participation (child)<br /><br>Performance of upper limb functioning in daily life (child)<br /><br>Quality of upper limb movements (child)<br /><br>(Therapy-related) parental stress (parents)<br /><br>Empowerment (parents)</p><br>