Sensitivity to Change of the Lower Extremity Functional S... | NCT01536990

Studies
Sensitivity to Change of the Lower Extremity Functional Scale in Patients With Stroke

NCT01536990

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Aug 31, 2023Actual

Enrollment

39Actual

Phase

Not provided

Conditions

Lower Extremity Dysfunction
Stroke

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

Status Module

Record Verification Date

Aug 2023

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

May 2007

Primary Completion Date

Dec 2010Actual

Completion Date

Jan 2011Actual

First Submitted Date

Feb 16, 2012

First Submission Date that Met QC Criteria

Feb 21, 2012

First Posted Date

Feb 22, 2012Estimated

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 29, 2023

Last Update Posted Date

Aug 31, 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

Description Module

Brief Summary

The purpose of this study was to investigate the reliability, construct validity, and sensitivity to change of the Lower Extremity Functional Scale (LEFS) in individuals affected by stroke.

Detailed Description

The purpose of this study was to investigate the reliability, construct validity, and sensitivity to change of the Lower Extremity Functional Scale (LEFS) in individuals affected by stroke. Patients were measured with the LEFS at the beginning and end of physical therapy treatment, or at 8 weeks of physical therapy treatment.

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

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stroke		Medically stable patients receiving inpatient or outpatient physical therapy care for lower extremity dysfunction secondary to stroke.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
LEFS	Lower Extremity Function Scale	36 days average (range 4-76 days)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Medically stable patients receiving inpatient or outpatient physical therapy care for lower extremity dysfunction due to stroke

Exclusion Criteria:

Unable to understand English
More than moderate assist for bed mobility and coming to sitting from the supine position
Lower extremity amputation
Unable to reach overhead, grasp an object, or feed self with an upper extremity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Medically stable patients receiving inpatient or outpatient physical therapy care for lower extremity dysfunction due to stroke.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph L Verheijde, PhD MBA PT	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Scottsdale	Arizona	85259	United States

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided