StrokeNCT06156813
Turkish Lower-Extremity Motor Activity Log (LE-MAL)
An observational study of Stroke and Spastic Paraplegia, run by Gaziantep Islam Science and Technology University at 1 site in Turkey (Türkiye).
Trial summary
The Motor Activity Log was developed to measure paretic upper extremity use in daily activities in the real-life context (real world) of people with different health conditions, including stroke. Subsequently, the Lower Extremity Motor Activity Diary was developed. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Spastic Paraplegia
- What is being tested?
- Diagnostic test
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2023to 15 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke patients
Who may be able to join
- Individuals between the ages of 18-80 living in Gaziantep who applied to the neurology outpatient clinic of Hospital and were diagnosed with stroke.
Who cannot join
- Patients with a history of trauma within the last year, alcohol and substance addiction, and pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziantep Islam Science and Technology University
Gaziantep
Zekiye İpek Katırcı kırmacı
About this study
Official title: Validity and Reliability of Turkish Version of the Lower Extremity Motor Activity Log
The Motor Activity Log was developed to measure paretic upper extremity use in daily activities in the real-life context (real world) of people with different health conditions, including stroke. Subsequently, the Lower Extremity Motor Activity Diary was developed. This survey is a semi-structured survey in which the participant is asked to rate himself/herself according to each scale over 14 activities.
Read the detailed description
The Motor Activity Log was developed to measure paretic upper extremity use in daily activities in the real-life context (real world) of people with different health conditions, including stroke. Real-world use outside the individual's clinical/laboratory environment, including daily activities (e.g., walking indoors and outdoors above ground, climbing stairs, getting in and out of a car, jumping over an object, picking up an object, sitting and standing) It's about what they do.
The Motor Activity Log is a reliable patient self-report measure and correlates significantly with another real-world measure, the accelerometer.
Adaptation of the Motor Activity Log to the lower extremity involved the development of three subscales to measure changes in types of activity that are bilateral in nature and use of the paretic lower extremity: level of assistance, functional ability, and confidence. The Lower Extremity Motor Activity Log is a semi-structured questionnaire in which the participant is asked to rate himself on each scale across 14 activities. The score for each scale is the average of the rate provided for each activity. Additionally, a composite score can be calculated that combines all scales through assistance, functional ability, and confidence scores.
A preliminary study with individuals with stroke using the English version of the Lower Extremity Motor Activity Log-14 showed that the total score was 0.93, 0.90, 0.94, and 0.88 test-retest for the composite score, assistance, functional ability, and confidence scales, respectively. The test showed that it has reliability.
The aim of this study is to investigate the reliability and validity of the Turkish version of the Lower Extremity Motor Activity Log-14.
- Conditions
- Stroke, Spastic Paraplegia
- Being tested
- Diagnostic test
- Keywords
- LE-MAL, Spasticity, Measurement, validity, reliability
- Medical subject headings
- Stroke, Paraplegia, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic testDiagnostic test
Measurements for validity and reliability
What is being measured
The primary outcome is the main question the study is designed to answer.
Tr- LE-MAL
t is a semi-structured interview that includes questions to determine the participant's level of assistance, movement quality and confidence while performing a 14-day activity.
Measured: baseline and two weeks later
Secondary outcomes (2)
Stroke Impact Scale
This scale, which aims to evaluate the perception of the quality of life after stroke by the patients themselves or their caregivers, consists of 8 subsections and 59 questions.
Measured: Baseline
6 min walk test
Functional capacity in terms of mobility is evaluated by measuring the person's maximum walking distance within a six-minute period.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start15 Nov 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziantep Islam Science and Technology University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zekiye İpek Katırcı Kırmacı, Principal investigator, Gaziantep Islam Science and Technology University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156813
- Sponsor's protocol ID
- ipek.kirmaci
- Status last verified
- Mar 2025
- First submitted
- 27 Nov 2023
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Turkish Version of the Lower Extremity Motor Activity Log
- ClinicalTrials.gov ID
- NCT06156813
- Acronym / sponsor ID
- ipek.kirmaci
- Conditions
- Stroke, Spastic Paraplegia
- Keywords
- LE-MAL, Spasticity, Measurement, validity, reliability
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Gaziantep Islam Science and Technology UniversityUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 5 Dec 2023 (actual)
- 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 Motor Activity Log was developed to measure paretic upper extremity use in daily activities in the real-life context (real world) of people with different health conditions, including stroke. Subsequently, the Lower Extremity Motor Activity Diary was developed. This survey is a semi-structured survey in which the participant is asked to rate himself/herself according to each scale over 14 activities.
Detailed description
The Motor Activity Log was developed to measure paretic upper extremity use in daily activities in the real-life context (real world) of people with different health conditions, including stroke. Real-world use outside the individual's clinical/laboratory environment, including daily activities (e.g., walking indoors and outdoors above ground, climbing stairs, getting in and out of a car, jumping over an object, picking up an object, sitting and standing) It's about what they do.
The Motor Activity Log is a reliable patient self-report measure and correlates significantly with another real-world measure, the accelerometer.
Adaptation of the Motor Activity Log to the lower extremity involved the development of three subscales to measure changes in types of activity that are bilateral in nature and use of the paretic lower extremity: level of assistance, functional ability, and confidence. The Lower Extremity Motor Activity Log is a semi-structured questionnaire in which the participant is asked to rate himself on each scale across 14 activities. The score for each scale is the average of the rate provided for each activity. Additionally, a composite score can be calculated that combines all scales through assistance, functional ability, and confidence scores.
A preliminary study with individuals with stroke using the English version of the Lower Extremity Motor Activity Log-14 showed that the total score was 0.93, 0.90, 0.94, and 0.88 test-retest for the composite score, assistance, functional ability, and confidence scales, respectively. The test showed that it has reliability.
The aim of this study is to investigate the reliability and validity of the Turkish version of the Lower Extremity Motor Activity Log-14.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients
Key inclusion criteria (1 listed)
- Individuals between the ages of 18-80 living in Gaziantep who applied to the neurology outpatient clinic of Hospital and were diagnosed with stroke.
Key exclusion criteria (1 listed)
- Patients with a history of trauma within the last year, alcohol and substance addiction, and pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic testMeasurements for validity and reliability | Diagnostic test | – |
Primary outcome
Tr- LE-MAL
Time frame: baseline and two weeks later
t is a semi-structured interview that includes questions to determine the participant's level of assistance, movement quality and confidence while performing a 14-day activity.
2 secondary outcomes
Stroke Impact Scale
Time frame: Baseline
6 min walk test
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
Not yet recruiting
Closed-Loop SCS-BCI for Post-Stroke Hemiplegia
Stroke, Motor Dysfunction
Active, not recruiting
Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke
Stroke, Cognitive Dysfunction
Not yet recruitingObservational study
A Speaking-Valve-Based Decannulation Protocol for Tracheostomized Stroke Patients
Stroke Patients, Tracheostomy
RecruitingPhase 4
Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals
Cerebrovascular Disorders
Not yet recruiting
Effect of Early Tendon Vibrations on Upper Limb Motor Recovery After a Stroke
Acute Stroke, Upper Limb Motor Deficit
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.
Zekiye İpek Katırcı Kırmacı principal investigator
Gaziantep Islam Science and Technology University
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 Stroke and Spastic Paraplegia, run by Gaziantep Islam Science and Technology University at 1 site in Turkey (Türkiye).
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 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: looking for participants now, as of the sponsor's last update on 11 Mar 2025. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zekiye İpek Katırcı Kırmacı, PhD (+90 544 261 82 85, ipekkatirci@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tr- LE-MAL (time frame: baseline and two weeks later). 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 11 Mar 2025; AzTrials last refreshed its copy on 30 Oct 2026.