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Implicit and explicit home-based training programs for young children with cerebral palsy: process evaluation and effectiveness on bimanual performance and parental stress

Implicit and explicit home-based training programs for young children with cerebral palsy: process evaluation and effectiveness on bimanual performance and parental stress - COAD: home-based training programs for young children with cerebral palsy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44919
Enrollment
24
Registered
2016-02-01
Start date
2016-04-14
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

spasticity unilateral Cerebral Palsy

Interventions

The treatments under study consist of home-based training protocols based on either implicit or explicit strategies regarding teaching. The interventions consist of three phases: preparation of the h
the actual home-based training program
and follow-up.

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)