Lower Extremity DysfunctionNCT01536990
Sensitivity to Change of the Lower Extremity Functional Scale in Patients With Stroke
An observational study of Lower Extremity Dysfunction and Stroke, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lower Extremity Dysfunction, Stroke
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jan 2011
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Medically stable patients receiving inpatient or outpatient physical therapy care for lower extremity dysfunction due to stroke.
Who may be able to join
- Medically stable patients receiving inpatient or outpatient physical therapy care for lower extremity dysfunction due to stroke
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sensitivity to Change of the Lower Extremity Functional Scale and a Single-Item Functional Assessment Tool in Patients With Neurological Impairments Secondary to Stroke
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.
Read the 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.
- Conditions
- Lower Extremity Dysfunction, Stroke
- Medical subject headings
- Stroke
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 |
|---|---|---|
| Stroke | Medically stable patients receiving inpatient or outpatient physical therapy care for lower extremity dysfunction secondary to stroke. |
What is being measured
The primary outcome is the main question the study is designed to answer.
LEFS
Lower Extremity Function Scale
Measured: 36 days average (range 4-76 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2012 (estimated)
- Study startMay 2007
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity DysfunctionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph L Verheijde, PhD MBA PT, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536990
- Sponsor's protocol ID
- 06-002770
- Status last verified
- Aug 2023
- First submitted
- 16 Feb 2012
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity to Change of the Lower Extremity Functional Scale and a Single-Item Functional Assessment Tool in Patients With Neurological Impairments Secondary to Stroke
- ClinicalTrials.gov ID
- NCT01536990
- Acronym / sponsor ID
- 06-002770
- Conditions
- Lower Extremity Dysfunction, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 22 Feb 2012 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke | – | –Medically stable patients receiving inpatient or outpatient physical therapy care for lower extremity dysfunction secondary to stroke. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Medically stable patients receiving inpatient or outpatient physical therapy care for lower extremity dysfunction due to stroke.
Key inclusion criteria (1 listed)
- Medically stable patients receiving inpatient or outpatient physical therapy care for lower extremity dysfunction due to stroke
Key exclusion criteria (4 listed)
- 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
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
LEFS
Time frame: 36 days average (range 4-76 days)
Lower Extremity Function Scale
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 31 Aug 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.
Joseph L Verheijde, PhD MBA PT principal investigator
Mayo Clinic
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 Lower Extremity Dysfunction and Stroke, run by Mayo Clinic 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 1 inclusion and 4 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 31 Aug 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 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?
LEFS (time frame: 36 days average (range 4-76 days)). 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 31 Aug 2023.