Clinical trial NCT06507631: Feasibility of the Blended Care Pirate Group
Official title: Feasibility and Effectiveness of the Blended Care Pirate Group for Children With Unilateral Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Palsy
Keywords: Home-based rehabilitation
Constrained induced movement therapy
Lead sponsor: Sint Maartenskliniek
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 16
Sex: ALL
Minimum age (years): 30
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with unilateral cerebral palsy who are being reffered to the local rehabilitation centre to participate in the pirate group.

Brief summary: Rationale: In 2010 Aarts developed the pirate group in which children received constrained induced movement therapy (constrained with a sling) followed by bilateral therapy. During this pirate group children were dressed as a pirate to increase motivation and to make the sling more meaningful. This pirate group had a duration of eight weeks with three times three hour training sessions each week. However, due to COVID-19 therapists were introduced to home-based rehabilitation. Therefore they developed the blended care pirate group, which is in principle the same as the pirate group of Aarts, however one training session each week is replaced by a home-based training session. It is however not yet clear how this blended care pirate group is perceived by parents and therapists.

Objective: The aim of the current study is to investigate the feasibility and effectiveness of the blended care pirate group.

Study population: Children with unilateral cerebral palsy between 2.5 and 8 years old will participate. These children will participate in the blended care pirate group and are asked to participate in the study as well.

Intervention: The total duration of one blended care pirate group is eight weeks with two times three hour training sessions at the rehabilitation centre and additional training sessions at home. The training sessions on-site will be the same as the conventional pirate group. For the training sessions at home parents will receive instructions and material from the therapists. This intervention is developed and already planned by therapists without direct influence of the research department and can therefore be considered as standard treatment.

Main study parameters/endpoints: The primary outcome are the total training hours performed by parents at home. Additionally after the blended care pirate group parents and therapists will participate in an interview about how they perceived the blended care pirate group. Secondary outcomes are improvements in arm function during the blended care pirate group.


Eligibility criteria: Inclusion Criteria:

* Receiving treatment at the Sint Maartenskliniek. Care demand of parents that requires a more and better use of the affected arm and hand.
* Children with unilateral cerebral palsy
* A Manual Ability Classification System (MACS) score of I, II or III

Exclusion Criteria:

* Cognitive developmental age below 2
* Child is not able to walk independently without a walking tool

Primary outcomes:
measure: Training hours
timeFrame: During the 8-week intervention period
Secondary outcomes:
measure: Interview with parents
timeFrame: After the 8-week intervention period
measure: Assisting Hand Assessment (AHA)
timeFrame: Before and after 8-week intervention
measure: Video observarion Aarts en Aarts - Determine Developmental Disregard - Revised (VOAA-DDD-R)
timeFrame: Before and after 8-week intervention
measure: Box and Block test (BBT)
timeFrame: Before and after 8-week intervention
Other outcomes:
Locations:
city: Ubbergen
country: Netherlands
facility: Sint Maartenskliniek
state: Gelderland
Study officials:
affiliation: Donders Institute for Brain, Cognition and Behavior, Radboud University
name: Noël Keijsers, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aarts PB, Jongerius PH, Geerdink YA, van Limbeek J, Geurts AC. Effectiveness of modified constraint-induced movement therapy in children with unilateral spastic cerebral palsy: a randomized controlled trial. Neurorehabil Neural Repair. 2010 Jul-Aug;24(6):509-18. doi: 10.1177/1545968309359767. Epub 2010 Apr 27.