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Completed

NCT Number: NCT06507631

Feasibility of the Blended Care Pirate Group

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

30 month–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sint Maartenskliniek

Ubbergen, Gelderland, 6574 NA, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blended care pirate group

Behavioral

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.

Primary outcomes

  1. Training hours

    Time frame: During the 8-week intervention period

    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.

Secondary outcomes

  1. Interview with parents

    Time frame: After the 8-week intervention period

    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.

  2. Assisting Hand Assessment (AHA)

    Time frame: Before and after 8-week intervention

    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.

  3. Video observarion Aarts en Aarts - Determine Developmental Disregard - Revised (VOAA-DDD-R)

    Time frame: Before and after 8-week intervention

    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.

  4. Box and Block test (BBT)

    Time frame: Before and after 8-week intervention

    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

Sponsors and collaborators

Lead sponsor

Sint Maartenskliniek

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2024
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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