Feasibility of the Blended Care Pirate Group

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Behavioral: Blended care pirate group

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Ubbergen, Gelderland, Netherlands, 6574 NA
      • Sint Maartenskliniek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Blended care pirate group; During the 8-week pirate group, children will receive two times three hour training sessions. Additionally, parents are advised to practise with their child at home for three hours per week.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sint Maartenskliniek
• Investigators: Principal Investigator: Noël Keijsers, Prof., Donders Institute for Brain, Cognition and Behavior, Radboud University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2022
• Primary Completion (Actual): October 30, 2024
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Home-based rehabilitation; Constrained induced movement therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 1054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No