Down Syndrome Clinical Trial
Official title:
An Investigation of Trunk Control in Young Children With Down Syndrome
NCT number | NCT03544840 |
Other study ID # | 20067 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2018 |
Est. completion date | January 31, 2019 |
Verified date | August 2019 |
Source | Texas Woman's University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Overall, the purpose of this dissertation research is to investigate trunk control in young
children with DS. This will be done in three studies:
1. The purpose of the first study is to determine the reliability of the SATCo in young
children with DS. The hypothesis is that the SATCo will demonstrate good (κ > 0.8)
interrater and intrarater reliability.
2. The purpose of the second study is to examine the validity of the SATCo with the GMFM-66
and determine whether age and SATCo score predict GMFM-66 score in young children with
DS. The hypotheses are that 1) the SATCo will show concurrent validity with the GMFM-66,
and 2) both age and SATCo scores will be significant predictors of GMFM-66 scores.
3. The purpose of the third study is to explore the impact of a dynamic standing device
(Upsee) on trunk control and motor skills in young children with DS. The hypothesis is
that participants will demonstrate a greater change in scores on the SATCo and the GMFM
during the dynamic standing home program phase than during the baseline phases.
Status | Completed |
Enrollment | 18 |
Est. completion date | January 31, 2019 |
Est. primary completion date | January 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 24 Months |
Eligibility |
Inclusion Criteria: 1. Diagnosis of DS. This is the diagnosis that is being investigated 2. Speak English. This is the language spoken by the PI. 3. Medically stable, without physician- ordered restrictions. Some children with DS have cardiac surgery or other complications that would contraindicate handling or movement. These children would not be considered medically stable. 4. Between the age of 6 to 24 months. This captures the full range of the outcome measure being investigated. Exclusion Criteria: 1. Meet inclusion and exclusion criteria for part 1 of the study. Children for part 2 of the study will be a sub-sample of those in part 1 of the study. 2. Between the age of 9 to 18 months. This captures the age when most children with DS are able to bear weight through their lower extremities, but before they can walk independently. This is necessary to be able to use the home programs and demonstrate gross motor changes. 3. Unable to ambulate independently. Children who can walk independently cannot use the home program devices. |
Country | Name | City | State |
---|---|---|---|
United States | University of St. Augustine for Health Sciences | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Woman's University | American Physical Therapy Association |
United States,
Butler PB, Saavedra S, Sofranac M, Jarvis SE, Woollacott MH. Refinement, reliability, and validity of the segmental assessment of trunk control. Pediatr Phys Ther. 2010 Fall;22(3):246-57. doi: 10.1097/PEP.0b013e3181e69490. — View Citation
Russell D, Palisano R, Walter S, Rosenbaum P, Gemus M, Gowland C, Galuppi B, Lane M. Evaluating motor function in children with Down syndrome: validity of the GMFM. Dev Med Child Neurol. 1998 Oct;40(10):693-701. — View Citation
Ulrich BD. Opportunities for early intervention based on theory, basic neuroscience, and clinical science. Phys Ther. 2010 Dec;90(12):1868-80. doi: 10.2522/ptj.20100040. Epub 2010 Oct 21. Review. — View Citation
Ulrich DA, Ulrich BD, Angulo-Kinzler RM, Yun J. Treadmill training of infants with Down syndrome: evidence-based developmental outcomes. Pediatrics. 2001 Nov;108(5):E84. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Segmental Assessment of Trunk Control | Assesses seated trunk control in children with neuromotor disorders. | 20 minutes | |
Primary | Gross Motor Function Measure | Assesses gross motor skills in children with Down syndrome | 40 minutes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04854122 -
Blood Flow Regulation in Individuals With Down Syndrome - Training Study
|
N/A | |
Completed |
NCT04020302 -
Self-Monitoring Shopping Intervention
|
N/A | |
Recruiting |
NCT01950624 -
DS-Connect {TM}: The Down Syndrome Registry
|
||
Completed |
NCT04751136 -
the Effect of Cerebrolysin on Physical and Mental Functions of Down Syndrome
|
Phase 2 | |
Completed |
NCT04767412 -
Inspiratory Muscle Training and Physical Fitness in Children With Down Syndrome Randomized Control Trial
|
N/A | |
Not yet recruiting |
NCT04037579 -
Protocol for a Non-randomized Survey in Down Syndrome People Who Practice Sports. Self and Observers´ Perception.
|
||
Completed |
NCT04536506 -
Bobath and Vojta Therapy for DS
|
N/A | |
Completed |
NCT02882698 -
Performance Analysis in Down Syndrome on Mobile Phone
|
N/A | |
Completed |
NCT01791725 -
A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia
|
Phase 2 | |
Unknown status |
NCT01975545 -
Fluor Varnish With Silver Nanoparticles for Dental Remineralization in Patients With Trisomy 21
|
Phase 2 | |
Completed |
NCT01808508 -
Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome
|
N/A | |
Terminated |
NCT00754013 -
Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 6 To 10
|
Phase 3 | |
Terminated |
NCT00754052 -
Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 11 To 17
|
Phase 3 | |
Completed |
NCT01313325 -
Hippotherapy to Improve the Balance of Children With Movement Disorders
|
N/A | |
Completed |
NCT01256112 -
Parent Supported Weight Reduction in Down Syndrome
|
N/A | |
Completed |
NCT01594346 -
Multicenter Vitamin E Trial in Aging Persons With Down Syndrome
|
Phase 3 | |
Completed |
NCT05343468 -
Life Skills Improved in Children With Down Syndrome After Using Assistive Technology
|
N/A | |
Suspended |
NCT05755464 -
Evaluation of Patients With Down Syndrome Compliance to Dental Therapy
|
||
Recruiting |
NCT04022460 -
Using Personal Mobile Technology to Identify Obstructive Sleep Apnea in Children With Down Syndrome (UPLOAD)
|
||
Completed |
NCT04818437 -
Effect of Core Stability Exercises and Balance Training in Postural Control Among Down Syndrome
|
N/A |