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CompletedNCT06507631Updated May 7, 2026

Feasibility of the Blended Care Pirate Group

An observational study in Cerebral Palsy, sponsored by Sint Maartenskliniek. Completed at 1 site in Netherlands. Open to participants aged 30 Months to 8 Years. Per ClinicalTrials.gov, last updated 2026-05-07.

Sponsored by Sint Maartenskliniek · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
17
Ages
30 Months to 8 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cerebral Palsy

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Keywords

  • Home-based rehabilitation
  • Constrained induced movement therapy
03

In context

Cerebral Palsy

1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.

This study's enrollment of 17 is below the median of 63 across 472 observational studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Sint Maartenskliniek is the lead sponsor of 29 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Months to 8 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Cognitive developmental age below 2
  • Child is not able to walk independently without a walking tool
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
17 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • BehavioralBlended 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: During the 8-week intervention period

Secondary outcomes

  1. 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.

    Time frame: After the 8-week intervention period

  2. 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.

    Time frame: Before and after 8-week intervention

  3. 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.

    Time frame: Before and after 8-week intervention

  4. 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

    Time frame: Before and after 8-week intervention

07

Study locations

1 site
  • Sint Maartenskliniek
    Ubbergen, Gelderland 6574 NA, Netherlands
08

References and documents

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. PubMed 20424191 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2022 to primary completion in Oct 2024, 27 months.

Of 214 non-industry observational studies under Cerebral Palsy, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 60. This study's 27 months is above that.

Counting every sponsor, half of 218 studies reached it within 21 months; a quarter within 8 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 6, 2024
First posted
Jul 18, 2024
StartActual
Jul 19, 2022
Primary completionActual
Oct 30, 2024
CompletionActual
Oct 30, 2024
Last update
May 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06507631
Lead sponsor
Sint Maartenskliniek
Responsible party
Sponsor
First posted
Jul 18, 2024
Start date
Jul 19, 2022
Primary completion
Oct 30, 2024
Completion
Oct 30, 2024
Last update
May 7, 2026

Study contacts

Noël Keijsers, Prof.
principal investigator · Donders Institute for Brain, Cognition and Behavior, Radboud University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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