NCT01536990

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 22, 2012

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

3.6 years

First QC Date

February 16, 2012

Last Update Submit

August 29, 2023

Conditions

Lower Extremity DysfunctionStroke

Outcome Measures

Primary Outcomes (1)

  • LEFS

    Lower Extremity Function Scale

    36 days average (range 4-76 days)

Study Arms (1)

Stroke

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

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Joseph L Verheijde, PhD MBA PT

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2012

First Posted

February 22, 2012

Study Start

May 1, 2007

Primary Completion

December 1, 2010

Study Completion

January 1, 2011

Last Updated

August 31, 2023

Record last verified: 2023-08

Locations

US(1)