Down SyndromeNCT00643955
Neuromuscular Characteristics of Individuals With Down Syndrome (DS)
An observational study of Down Syndrome, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
Evaluation of muscle strength and central activation of muscle in individuals with Down Syndrome Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome
- What is being tested?
- muscle strength
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Individuals with Down Snydrome and control subjects without DS
Who may be able to join
- 18-45 years old
- good health with no contraindications to exercise
- documented DS (not for control subjects)
Who cannot join
- contraindications to exercise,
- severe or profound MR
- documented atherosclerotic heart disease
- documented atlantoaxial instability
- uncorrected congenital heart disease
- implanted prosthetic device
- implanted pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromuscular Characteristics of Individuals With Down Syndrome
Evaluation of muscle strength and central activation of muscle in individuals with Down Syndrome
- Conditions
- Down Syndrome
- Being tested
- muscle strength
- Keywords
- Evaluation of muscle strength and central activation
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
muscle strengthOther
muscle strength
| Study group | Role | What they receive |
|---|---|---|
| DS | Individual with Down Syndrome Receives: Other: muscle strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength Central activation ratio
Measured: One time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643955
- Sponsor's protocol ID
- 5495
- Status last verified
- Dec 2023
- First submitted
- 24 Mar 2008
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Characteristics of Individuals With Down Syndrome
- ClinicalTrials.gov ID
- NCT00643955
- Acronym / sponsor ID
- 5495
- Conditions
- Down Syndrome
- Keywords
- Evaluation of muscle strength and central activation
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 15 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Mar 2009 (actual)
- First posted
- 26 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of muscle strength and central activation of muscle in individuals with Down Syndrome
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DS | – | Other: muscle strengthIndividual with Down Syndrome |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Individuals with Down Snydrome and control subjects without DS
Key inclusion criteria (3 listed)
- 18-45 years old
- good health with no contraindications to exercise
- documented DS (not for control subjects)
Key exclusion criteria (7 listed)
- contraindications to exercise,
- severe or profound MR
- documented atherosclerotic heart disease
- documented atlantoaxial instability
- uncorrected congenital heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| muscle strengthmuscle strength | Other | DS |
Primary outcome
Muscle strength Central activation ratio
Time frame: One time
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Down Syndrome, run by State University of New York - Upstate Medical University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength Central activation ratio (time frame: One time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.