Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06591559
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-12
Brief Title:
Up Down and All Around Evaluating Mobility Devices for Young Children with Down Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Up Down and All Around Evaluating Mobility Devices for Young Children with Down Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
This research study will examine young children with Down syndromes initial experiences with mobility devices Childrens biomechanics and exploration will be quantified while they are using both an overground partial bodyweight support system and powered mobility device
Detailed Description:
Young children with Down syndrome experience delays in cognition communication and mobility As a result of cerebellar hypoplasia children with Down syndrome have altered balance and coordination muscle hypotonia decreased muscle strength and ligament laxity Low muscle tone and ligament laxity can lead to the adoption of unfavorable postures putting children at risk for developing musculoskeletal disorders in the future
While children with Down syndrome are expected to walk they do so significantly later than their peers creating a gap in mobility exploration and socialization in the first years of life Mobility during the first years is crucial to facilitate cascades of reciprocal development in cognition communication and motor skills as well as reduce developmental delays and participation disparities for children with Down syndrome compared to their peers While early intervention is common during this time to facilitate movement clinical practice patterns vary widely and there are few evidence-based interventions or assistive technologies to support children and their families
Treadmill training is currently the only intervention that has demonstrated efficacy for young children with hypotonia but only for improving walking speed among already ambulatory children Traditional treadmill training is limited however in that it does not allow for the sensorimotor experiences and social interactions that occur with self-initiated mobility in enriched and often unpredictable natural environments As such treadmill training and other clinical interventions may not fully address the need for holistic and multi-modal mobility opportunities
Augmented mobility - in the form of partial bodyweight support systems gait trainers and powered mobility - has been proposed as a promising and complementary intervention to support early development in Down syndrome While these tools have the potential to bridge the gap in self-initiated mobility and accelerate the onset of independent walking little is scientifically known about how children engage with these devices nor how these devices shape their interactions with their environment Furthermore there is a lack of knowledge concerning the impact of different mobility devices on a childs physical development and posture
In this research the investigators propose to quantify a childs exploration posture and motor control strategies while using two promising assistive technologies for pre-ambulatory young children with Down syndrome a partial-bodyweight support system PUMA Enliten LLC and a powered mobility device Explorer Mini Permobil that can be used in both seated and standing postures
Participants will attend a total of four play sessions where they will play with a no devices b partial bodyweight support c in the Explorer Mini in a standing posture and d in the Explorer Mini in a seated posture
While children with Down syndrome are expected to walk they do so significantly later than their peers creating a gap in mobility exploration and socialization in the first years of life Mobility during the first years is crucial to facilitate cascades of reciprocal development in cognition communication and motor skills as well as reduce developmental delays and participation disparities for children with Down syndrome compared to their peers While early intervention is common during this time to facilitate movement clinical practice patterns vary widely and there are few evidence-based interventions or assistive technologies to support children and their families
Treadmill training is currently the only intervention that has demonstrated efficacy for young children with hypotonia but only for improving walking speed among already ambulatory children Traditional treadmill training is limited however in that it does not allow for the sensorimotor experiences and social interactions that occur with self-initiated mobility in enriched and often unpredictable natural environments As such treadmill training and other clinical interventions may not fully address the need for holistic and multi-modal mobility opportunities
Augmented mobility - in the form of partial bodyweight support systems gait trainers and powered mobility - has been proposed as a promising and complementary intervention to support early development in Down syndrome While these tools have the potential to bridge the gap in self-initiated mobility and accelerate the onset of independent walking little is scientifically known about how children engage with these devices nor how these devices shape their interactions with their environment Furthermore there is a lack of knowledge concerning the impact of different mobility devices on a childs physical development and posture
In this research the investigators propose to quantify a childs exploration posture and motor control strategies while using two promising assistive technologies for pre-ambulatory young children with Down syndrome a partial-bodyweight support system PUMA Enliten LLC and a powered mobility device Explorer Mini Permobil that can be used in both seated and standing postures
Participants will attend a total of four play sessions where they will play with a no devices b partial bodyweight support c in the Explorer Mini in a standing posture and d in the Explorer Mini in a seated posture
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