Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507631
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-03-06
Brief Title:
Feasibility of the Blended Care Pirate Group
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility and Effectiveness of the Blended Care Pirate Group for Children With Unilateral Cerebral Palsy
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 25 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 parametersendpoints 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
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 25 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 parametersendpoints 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None