Characterizing Upper Extremity Function in Individuals Wi... | NCT02398149

Studies
Characterizing Upper Extremity Function in Individuals With Multiple Sclerosis

NCT02398149

Sponsor

Mount Sinai Rehabilitation Hospital

Status

Completed

Last Update Posted

Aug 30, 2017Actual

Enrollment

267Actual

Phase

Not provided

Conditions

Multiple Sclerosis

Interventions

Not provided

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

ID	Type	Description	Link
RG 4815A2/2	Other Grant/Funding Number	National Multiple Sclerosis Society

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Oct 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

Mar 2, 2015

First Submission Date that Met QC Criteria

Mar 19, 2015

First Posted Date

Mar 25, 2015Estimated

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

Aug 28, 2017

Last Update Posted Date

Aug 30, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jennifer Ruiz, DPT, Research Manager, Mandell MS Center, Mount Sinai Rehabilitation HospitalPrincipal Investigator

Lead Sponsor

Mount Sinai Rehabilitation HospitalOTHER

Collaborators

Name	Class
National Multiple Sclerosis Society	OTHER

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

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

267Actual

Label	Type	Description	Intervention Names
PwMS receiving care at the Mandell Center

Measure	Description	Time Frame
Prevalance of Impairment in the Upper Extremity		3hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Unwilling or unable to complete assessments

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Persons with MS who receive care at the Mandell Center for Multiple Sclerosis.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mandell Center for Multiple Sclerosis at the Mount Sinai Rehabilitation Hospital		Hartford	Connecticut	06112	United States

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided