Ignite Creation Date:
2024-05-06 @ 7:32 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06040619
Status:
RECRUITING
Last Update Posted:
2023-12-21
First Post:
2023-08-28
Brief Title:
Implementation of Therapy Together
Sponsor:
Texas Scottish Rite Hospital for Children
Organization:
Texas Scottish Rite Hospital for Children
Study Overview
Official Title:
Implementation of Therapy Together With the State of Texas Early Childhood Intervention Program
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this pilot clinical trial is to learn about the implementation of Therapy Together a pediatric constraint-induced movement therapy program in young children with unilateral cerebral palsy The main questions it aims to answer are
Is the Therapy Together program effective in improving hand function and occupational performance compared to usual care
Is it feasible to implement the Therapy Together program within the standard care early intervention framework
Participants will participate in an 8-week pediatric constraint-induced movement therapy program Researchers will compare the group completing the Therapy Together Program to a group that is receiving usual care to see if there is a difference in the change in hand function occupational performance and development
Is the Therapy Together program effective in improving hand function and occupational performance compared to usual care
Is it feasible to implement the Therapy Together program within the standard care early intervention framework
Participants will participate in an 8-week pediatric constraint-induced movement therapy program Researchers will compare the group completing the Therapy Together Program to a group that is receiving usual care to see if there is a difference in the change in hand function occupational performance and development
Detailed Description:
A pilot randomized waitlist control trial with early intervention therapists infantstoddlers ages 3 mo - 2 yrs 11 mo with unilateral cerebral palsy or at risk for developing cerebral palsy and caregivers comparing Therapy Together to usual care followed by semi-structured interviews with caregivers and therapists will be utilized to examine the implementation and effectiveness of Therapy Together within early intervention
Therapy Together Program
The Therapy Together program includes caregiver education and coaching on implementing therapeutic activities that are play-based age-appropriate and tailored to meet goals to improve armhand function The child and caregiver complete 8 sessions with their early intervention therapist The early intervention therapist is trained to educate the caregiver on the Therapy Together program demonstrate how to engage the child in therapeutic activities and observe the caregiver implement the program during each weekly session The first 7 intervention visits focus on constraint-induced movement therapy CIMT and the final intervention visit focuses on bimanual therapy use of two hands
Therapy Together Program
The Therapy Together program includes caregiver education and coaching on implementing therapeutic activities that are play-based age-appropriate and tailored to meet goals to improve armhand function The child and caregiver complete 8 sessions with their early intervention therapist The early intervention therapist is trained to educate the caregiver on the Therapy Together program demonstrate how to engage the child in therapeutic activities and observe the caregiver implement the program during each weekly session The first 7 intervention visits focus on constraint-induced movement therapy CIMT and the final intervention visit focuses on bimanual therapy use of two hands
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None