Neuromuscular Characteristics of Individuals With Down Sy... | NCT00643955

Studies
Neuromuscular Characteristics of Individuals With Down Syndrome (DS)

NCT00643955

Sponsor

State University of New York - Upstate Medical University

Status

Terminated

Last Update Posted

Dec 21, 2023Actual

Enrollment

15Actual

Phase

Not provided

Conditions

Down Syndrome

Interventions

muscle strength

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Mar 2009Actual

Completion Date

Not provided

First Submitted Date

Mar 24, 2008

First Submission Date that Met QC Criteria

Mar 25, 2008

First Posted Date

Mar 26, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2023

Last Update Posted Date

Dec 21, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DS		Individual with Down Syndrome	Other: muscle strength

Interventions

Name	Type	Description	Arm Group Labels	Other Names
muscle strength	Other	muscle strength	DS

Measure	Description	Time Frame
Muscle strength Central activation ratio		One time

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-45 years old
good health with no contraindications to exercise
documented DS (not for control subjects)

Exclusion Criteria:

contraindications to exercise,
severe or profound MR
documented atherosclerotic heart disease
documented atlantoaxial instability
uncorrected congenital heart disease
implanted prosthetic device
implanted pacemaker

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Individuals with Down Snydrome and control subjects without DS

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
IHP		Syracuse	New York	13210	United States

Condition Browse Module

MeSH Terms

ID	Term
D004314	Down Syndrome

Ancestor Terms

ID	Term
D008607	Intellectual Disability
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D053580	Muscle Strength

Ancestor Terms

ID	Term
D010808	Physical Examination
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D009142	Musculoskeletal Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided