Feasibility of the Blended Care Pirate Group
NCT Number: NCT06507631
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cerebral Palsy
Interventions: BEHAVIORAL: Blended care pirate group
Sponsor: Sint Maartenskliniek
Sex: ALL
Age: CHILD
Enrollment: 16
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-07-19
Completion Date: 2024-10-30
Locations: Sint Maartenskliniek, Ubbergen, Gelderland, 6574 NA, Netherlands

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.

Primary Outcome Measures: Training hours, Training hours at home will be logged by parents. The total training hours will be compared to the advised training duration of three hours per week., During the 8-week intervention period
Secondary Outcome Measures: Interview with parents, After each pirate group, interviews with parents will be held about their experiences of training at home. A thematic analysis will be performed to analyse the interviews., After the 8-week intervention period|Assisting Hand Assessment (AHA), The AHA will be performed to measure the arm use during bimanual activities. The scale ranges between 0-100, with a higher score meaning better arm use., Before and after 8-week intervention|Video observarion Aarts en Aarts - Determine Developmental Disregard - Revised (VOAA-DDD-R), The VOAA-DDD-R measures the spontaneous arm use of the affected upper limb during two activities. During one activity it is required to use both hand, and during the second it is most efficient to use both hands. The score is the difference in arm use between the two tests. This score ranges between 0-100% with a lower score indicating better spontaneous arm use., Before and after 8-week intervention|Box and Block test (BBT), This test measures the unilateral gross manual dexterity. Children have to transfer blocks for one box to the other. There is no maximum score, a higher score indicating better hand function, Before and after 8-week intervention