spasticity unilateral Cerebral Palsy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Process evaluation: fidelity (quality), dose delivered (completeness), dose received (exposure and satisfaction), recruitment and context. Effects: Change in performance of predetermined, individual treatment goals, focused on bimanual daily life activities (child) and therapy-related stress (parents). | — |
Secondary
| Measure | Time frame |
|---|---|
| Effects: Bimanual performance (child) Performance of predetermined, individual rehabilitation goals (child) Satisfaction of the parents of the performance of predetermined, individual rehabilitation goals (child) Participation (child) Performance of upper limb functioning in daily life (child) Quality of upper limb movements (child) (Therapy-related) parental stress (parents) Empowerment (parents) | — |
Countries
Netherlands