Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579027
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
A Novel Program Using Ride-on Toys to Improve Upper Extremity Function in Children With Hemiplegia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Novel Child-friendly Home-based Navigation Training Program Using Joystick-operated Ride-on Toys to Improve Upper Extremity Function in Children With Hemiplegia A Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-08
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:
The purpose of this study is to assess the feasibility and utility of 2 types of play-based training programs co-delivered by researchers and caregivers within homecommunity settings to promote arm function among 3-to-8-year-old children with hemiplegia Specifically investigators will assess the feasibility of implementation and acceptancesatisfaction associated with a researcher-caregiver co-delivered community-based training program involving either joystick-operated powered ride-on toys SPEED training or creative upper extremity training CRAFT training
The investigators will also compare the effects of these 2 types of training programs on childrens arm motor function and spontaneous use of their affected arm during daily activities
The investigators will also compare the effects of these 2 types of training programs on childrens arm motor function and spontaneous use of their affected arm during daily activities
Detailed Description:
Prior to the start of the study researchers will conduct a phone screening with the family to confirm their childs eligibility to participate in the study Once eligibility is confirmed during the pretest session week 1 standardized assessments will be conducted to evaluate the childs ability to use their affected arm for different functional activities During this testing visit researchers will also attach small sensors on the childs arms and ask them to complete arm movements and functional tasks eg lifting blocks and putting them into a small cup At the pretest the child will also be provided 2 activity monitors similar to wrist watches to wear on both wrists for 1 week The activity monitors will allow the researchers to track the childs habitual arm activity over the duration of a week In addition caregivers will be asked to complete questionnaires to obtain information on their childs overall health development and their ability to use their affected arm for various activities of daily living
Assessments and questionnaires will be repeated again at the posttest ie at week 8 that corresponds with completion of the 6-week intervention phase and at 1-month follow-up following intervention completion ie week 12
Following the pretest the child will be randomized into one of the training groups SPEED or CRAFT During the 6-week intervention phase the research team will visit the childs homecommunity 2 timesweek to provide the training Caregivers will be requested to practice 2 additional sessions every week with their child in both groups
Children in the Strength and Power in upper Extremities through Exploratory Driving SPEED training group will engage in multidirectional navigation games and object-based upper extremity quests using the ride-on toys The toy will be modified to enable operation in a single joystick control mode with the joystick control provided on the childs affected side The training activities will be designed to encourage children to use their affected arm for training activities The training will involve children driving through incrementally challenging coursespaths and completing object-based tasks that require use of their affected arm for reaching grasping release and fine manipulation activities Children will be asked to wear a mitten on their unaffected hand during the sessions Children in the Creative Rehabilitation for Arm Functional Training CRAFT group will engage in seated creative motor games that will encourage use of their affected arm Training activities will involve stretching and strengthening exercises building activities eg using Play-doh blocks etc and art-craft projects all of which will require the skillful use of the affected arm for reach grasp release and manipulation activities
Research-delivered sessions in both groups will last around 30-45 minutes Caregivers will be encouraged to provide 2 more sessions every week lasting about 15-20 minutessession The research team will provide caregivers in both groups with the required materials for caregiver sessions In the SPEED group the ride-on toy will be left with the family for the duration of the intervention ie 6 weeks Both researchers and caregivers will be asked to keep track of training sessions duration frequency etc using a training log During the course of the study children in both groups will continue to receive treatment-as-usual through school or private settings Families will be asked to log the therapies their child is receiving every week over the course of the study using a training diary of timesweek duration of each session type of therapy received provided by the researchers Researchers will video record all testing and researcher-delivered training sessions so that childrens performance can be scored later
Assessments and questionnaires will be repeated again at the posttest ie at week 8 that corresponds with completion of the 6-week intervention phase and at 1-month follow-up following intervention completion ie week 12
Following the pretest the child will be randomized into one of the training groups SPEED or CRAFT During the 6-week intervention phase the research team will visit the childs homecommunity 2 timesweek to provide the training Caregivers will be requested to practice 2 additional sessions every week with their child in both groups
Children in the Strength and Power in upper Extremities through Exploratory Driving SPEED training group will engage in multidirectional navigation games and object-based upper extremity quests using the ride-on toys The toy will be modified to enable operation in a single joystick control mode with the joystick control provided on the childs affected side The training activities will be designed to encourage children to use their affected arm for training activities The training will involve children driving through incrementally challenging coursespaths and completing object-based tasks that require use of their affected arm for reaching grasping release and fine manipulation activities Children will be asked to wear a mitten on their unaffected hand during the sessions Children in the Creative Rehabilitation for Arm Functional Training CRAFT group will engage in seated creative motor games that will encourage use of their affected arm Training activities will involve stretching and strengthening exercises building activities eg using Play-doh blocks etc and art-craft projects all of which will require the skillful use of the affected arm for reach grasp release and manipulation activities
Research-delivered sessions in both groups will last around 30-45 minutes Caregivers will be encouraged to provide 2 more sessions every week lasting about 15-20 minutessession The research team will provide caregivers in both groups with the required materials for caregiver sessions In the SPEED group the ride-on toy will be left with the family for the duration of the intervention ie 6 weeks Both researchers and caregivers will be asked to keep track of training sessions duration frequency etc using a training log During the course of the study children in both groups will continue to receive treatment-as-usual through school or private settings Families will be asked to log the therapies their child is receiving every week over the course of the study using a training diary of timesweek duration of each session type of therapy received provided by the researchers Researchers will video record all testing and researcher-delivered training sessions so that childrens performance can be scored later
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