To assess fidelity (quality), dose delivered (completeness), dose received (exposure and satisfaction), recruitment and context of two newly developed upper limb home-based training programs, i.e. one based on implicit strategies and one based on…
ID
Source
Brief title
Condition
- Congenital and peripartum neurological conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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)
Background summary
Home-based training programs can be a useful addition to institutional
occupational and physical therapy for children with Cerebral Palsy (CP) for
several reasons, for instance promoting parental involvement, healthcare
independence and continuation of therapy aspects following institutional
therapy. Even though there is a general consensus on the importance of
home-based training programs, to date no evidence-based best practice exists
for bimanual home-based training.
Study objective
To assess fidelity (quality), dose delivered (completeness), dose received
(exposure and satisfaction), recruitment and context of two newly developed
upper limb home-based training programs, i.e. one based on implicit strategies
and one based on explicit strategies regarding teaching (of children by
parents), in young children (aged 2 through 7 years) with unilateral spastic
CP.
Study design
A mixed methods process evaluation, embedded in a multi-centre,
assessor-blinded comparative case series study.
Intervention
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 home-based
training program (i.e. formulating treatment goals, designing
the home-based training program and training of the parents); the actual
home-based training program; and follow-up.
Study burden and risks
Risk associated with participation is negligible, but the burden of
participation is substantial, particularly for parents. Parents will watch
videos and will be home visited by a therapist at the start of the actual
home-based training program. For a period of twelve weeks, parents will
practice with their child for 3.5 hours per week. The home-based training
programs consist of tasks comparable to activities of daily living. During the
home-based training program, the therapist will visit the children and parents
at week 5 and week 9 at their home, video registrations will be made at home by
the parents on a weekly basis, and parents will register training-related
activities on a daily basis in digital files. Children of all treatment arms
will visit a rehabilitation centre three times for a measurement session. The
sessions will consist of non-invasive tests (children), and a short interview
(parents). Furthermore, parents will complete questionnaires at home and will
three times be interviewed. The proposed study is considered a therapeutic
study.
Universiteitssingel 40
Maastricht 6229 HR
NL
Universiteitssingel 40
Maastricht 6229 HR
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL53670.091.15 |
| OMON | NL-OMON29631 |