Clinical trial NCT06156813: Turkish Lower-Extremity Motor Activity Log (LE-MAL)
Official title: Validity and Reliability of Turkish Version of the Lower Extremity Motor Activity Log
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Spastic Paraplegia
Keywords: LE-MAL
Spasticity
Measurement
validity
reliability
Lead sponsor: Gaziantep Islam Science and Technology University
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stroke patients

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Individuals between the ages of 18-80 living in Gaziantep who applied to the neurology outpatient clinic of Hospital and were diagnosed with stroke.

Exclusion Criteria:

* Patients with a history of trauma within the last year, alcohol and substance addiction, and pregnancy

Primary outcomes:
measure: Tr- LE-MAL
timeFrame: baseline and two weeks later
Secondary outcomes:
measure: Stroke Impact Scale
timeFrame: Baseline
measure: 6 min walk test
timeFrame: Baseline
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Gaziantep Islam Science and Technology University
Study officials:
affiliation: Gaziantep Islam Science and Technology University
name: Zekiye İpek Katırcı Kırmacı
role: PRINCIPAL_INVESTIGATOR
References: