NCT06507631

Feasibility of the Blended Care Pirate Group

Feasibility and Effectiveness of the Blended Care Pirate Group for Children With Unilateral Cerebral Palsy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 16 (estimated)
• Sponsor: Sint Maartenskliniek · Academic / Other
• Sex: All
• Age: 30 Months – 8 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
BEHAVIORAL	Blended care pirate group	During the blended care pirate group, children will receive training while their less affected arm is in a sling. They will perform play-like activities with their affected arm both on-site and at home.

Timeline

• Start date: 2022-07-19
• Primary completion: 2024-10-30
• Completion: 2024-10-30
• First posted: 2024-07-18
• Last updated: 2024-07-18

Locations

1 site across 1 country: Netherlands