Multiple SclerosisNCT02398149
Characterizing Upper Extremity Function in Individuals With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Mount Sinai Rehabilitation Hospital at 1 site in United States.
Trial summary
Upper extremity (UE) function is critical to maintaining independence. Better understanding of UE involvement in MS will provide necessary information to prioritize the design and selection of future interventions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 267 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Oct 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons with MS who receive care at the Mandell Center for Multiple Sclerosis.
Who may be able to join
- Confirmed clinical Clinical diagnosis of MS
- Receive MS care at the Mandell MS Center
- Cognitively able to understand directions and complete protocol
- Signed consent form approved by the Saint Francis Institutional Review Board
- 18 years of age or older
Who cannot join
- Unwilling or unable to complete assessments
Trial locations and contacts
1 site in 1 country.
United States1 site
Mandell Center for Multiple Sclerosis at the Mount Sinai Rehabilitation Hospital
Hartford, Connecticut, 06112
About this study
Upper extremity (UE) function is critical to maintaining independence. Better understanding of UE involvement in MS will provide necessary information to prioritize the design and selection of future interventions. The goal of the proposed project is to characterize UE involvement in a population of community-based persons with MS across the International Classification of Functioning, Disability \& Health (ICF) domains and constructs.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PwMS receiving care at the Mandell Center | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalance of Impairment in the Upper Extremity
Measured: 3hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startOct 2013
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Principal investigator, Jennifer Ruiz, DPT, Mount Sinai Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398149
- Sponsor's protocol ID
- 13-12-002-E
- Other IDs
- RG 4815A2/2
- Status last verified
- Aug 2017
- First submitted
- 2 Mar 2015
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Upper Extremity Function in Individuals With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02398149
- Acronym / sponsor ID
- 13-12-002-E
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Mount Sinai Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- Oct 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 25 Mar 2015 (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.
Upper extremity (UE) function is critical to maintaining independence. Better understanding of UE involvement in MS will provide necessary information to prioritize the design and selection of future interventions. The goal of the proposed project is to characterize UE involvement in a population of community-based persons with MS across the International Classification of Functioning, Disability \& Health (ICF) domains and constructs.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PwMS receiving care at the Mandell Center | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons with MS who receive care at the Mandell Center for Multiple Sclerosis.
Key inclusion criteria (5 listed)
- Confirmed clinical Clinical diagnosis of MS
- Receive MS care at the Mandell MS Center
- Cognitively able to understand directions and complete protocol
- Signed consent form approved by the Saint Francis Institutional Review Board
- 18 years of age or older
Key exclusion criteria (1 listed)
- Unwilling or unable to complete assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalance of Impairment in the Upper Extremity
Time frame: 3hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
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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 Multiple Sclerosis, run by Mount Sinai Rehabilitation Hospital 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 30 Aug 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalance of Impairment in the Upper Extremity (time frame: 3hours). 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 30 Aug 2017.