Feasibility of the Blended Care Pirate Group

Last updated: July 11, 2024
Sponsor: Sint Maartenskliniek
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cerebral Palsy

Treatment

Blended care pirate group

Clinical Study ID

NCT06507631
1054
  • Ages 30-8
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Receiving treatment at the Sint Maartenskliniek. Care demand of parents thatrequires 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

Exclusion Criteria:

  • Cognitive developmental age below 2

  • Child is not able to walk independently without a walking tool

Study Design

Total Participants: 16
Treatment Group(s): 1
Primary Treatment: Blended care pirate group
Phase:
Study Start date:
July 19, 2022
Estimated Completion Date:
October 30, 2024

Connect with a study center

  • Sint Maartenskliniek

    Ubbergen, Gelderland 6574 NA
    Netherlands

    Active - Recruiting

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