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

Sponsor
Gaziantep Islam Science and Technology University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06156813
Collaborator
(none)
80
1
7
11.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Diagnostic test

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

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Validity and Reliability of Turkish Version of the Lower Extremity Motor Activity Log
Actual Study Start Date :
Nov 15, 2023
Anticipated Primary Completion Date :
May 15, 2024
Anticipated Study Completion Date :
Jun 15, 2024

Outcome Measures

Primary Outcome Measures

  1. Tr- LE-MAL [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.

Secondary Outcome Measures

  1. Stroke Impact Scale [Baseline]

    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.

  2. 6 min walk test [Baseline]

    Functional capacity in terms of mobility is evaluated by measuring the person's maximum walking distance within a six-minute period.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gaziantep Islam Science and Technology University Gaziantep Turkey

Sponsors and Collaborators

  • Gaziantep Islam Science and Technology University

Investigators

  • Principal Investigator: Zekiye İpek Katırcı Kırmacı, Gaziantep Islam Science and Technology University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gaziantep Islam Science and Technology University
ClinicalTrials.gov Identifier:
NCT06156813
Other Study ID Numbers:
  • ipek.kirmaci
First Posted:
Dec 5, 2023
Last Update Posted:
Dec 5, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gaziantep Islam Science and Technology University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 5, 2023