Feasibility of the Blended Care Pirate Group

NCT06507631 | Recruiting

• 1 other identifier: 1054
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Home-based rehabilitation; Constrained induced movement therapy

Outcome Measures

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.

  During the 8-week intervention period

Secondary Outcomes (4)

• Interview with parents

  After the 8-week intervention period

• Assisting Hand Assessment (AHA)

  Before and after 8-week intervention

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

  Before and after 8-week intervention

• Box and Block test (BBT)

  Before and after 8-week intervention

Study Arms (1)

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

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.

Blended care pirate group

Eligibility Criteria

• Age: 30 Months - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sint Maartenskliniek: lead

Study Sites (1)

Sint Maartenskliniek

Ubbergen, Gelderland, 6574 NA, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 20424191 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Noël Keijsers, Prof.

  Donders Institute for Brain, Cognition and Behavior, Radboud University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Merle Matijsen, MSc

CONTACT

m.matijsen@maartenskliniek.nl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: July 18, 2024
• Study Start: July 19, 2022
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)