Turkish Lower-Extremity Motor Activity Log (LE-MAL)

Stroke Clinical Trial

Official title:

Validity and Reliability of Turkish Version of the Lower Extremity Motor Activity Log

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06156813
• Other study ID #: ipek.kirmaci
• Status: Recruiting
• Start date: November 15, 2023
• Est. completion date: June 15, 2024

Study information

• Verified date: November 2023
• Source: Gaziantep Islam Science and Technology University
• Contact: Zekiye Ipek Katirci Kirmaci, PhD
• Phone: +90 544 261 82 85
• Email: ipekkatirci[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. This survey is a semi-structured survey in which the participant is asked to rate himself/herself according to each scale over 14 activities.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 15, 2024
• Est. primary completion date: May 15, 2024
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Paraplegia
• Spastic Paraplegia
• Stroke

Intervention

Diagnostic Test:
• Diagnostic test
Measurements for validity and reliability

Locations

Country	Name	City	State
Turkey	Gaziantep Islam Science and Technology University	Gaziantep

Sponsors (1)

Lead Sponsor	Collaborator
Gaziantep Islam Science and Technology University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline and two weeks later
Secondary	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.	Baseline
Secondary	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.	Baseline