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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06122740
Other study ID # 2663-GOA
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 15, 2016
Est. completion date June 30, 2017

Study information

Verified date February 2024
Source Istanbul Medeniyet University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study aim was to investigate the validity and reliability of Turkish version of Manual Ability Measure-36 (MAM-36) in patients with neurological disease.


Description:

The reliability and validity of the scale were initiated by language equivalence and cultural adaptation. The MAM-36 scale was translated into Turkish by two experienced physiotherapists who are native Turkish speakers and have a good command of English, following the translation procedures. The two translations were compared with each other and a single Turkish draft was created. This draft was translated back into English by two translators who are native English speakers and have a good command of Turkish. The two back translations were compared to each other and converted into a single form. The resulting form was compared with the original form and the final back-translation scale was created. All translation formats of the scale were examined in detail by those who translated the scale into Turkish and a jury consisting of experienced physiotherapists. At the end of the meeting, the pilot study form of the scale was created. The created draft was applied to 30 healthy individuals as a pilot study. The final version of the scale was created by evaluating the feedback obtained. The clinical phase of the study was carried out on 250 volunteer individuals who applied to Dokuz Eylül University Hospital Neurology Department Polyclinics and were diagnosed with MS, Parkinson's disease, and stroke, and who had various degrees of problems in hand dexterity and functions due to their diseases. To evaluate the validity of MAM-36, Disability of Arm Shoulder and Hand (DASH), which can measure manual dexterity and was validated in Turkish, was used. The scales were repeated 15 days later to assess test-retest reliability.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date June 30, 2017
Est. primary completion date January 25, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Being diagnosed with a neurological disease (Stroke, Parkinson's or MS) - At least one upper extremity is affected - Being conscious enough to complete the survey and knowing how to read and write - Agreeing to participate in the research - Being over 18 years old Exclusion Criteria: - Having an upper extremity operation within the last 6 months - Having had an attack or seizure in the last month - Participating in any physical therapy program during the study

Study Design


Intervention

Other:
Turkish Validity and Reliability of The MAM-36 Scale
The aim of this study is to adapt the Manual Ability Measure-36 (MAM-36) scale to Turkish society and to make its validity and reliability in Turkish.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medeniyet University

Outcome

Type Measure Description Time frame Safety issue
Primary Manual Ability Measure-36 Manual Ability Measure-36 was used to measure hand functions. The scale is a task- and patient-oriented measurement tool. Scale items consist of tasks that are frequently performed in daily life. In the survey where individuals subjectively evaluate their manual skills, a 4-point Likert rating scale is used, where 1 is 'I cannot do', 2 is 'very difficult', 3 is 'somewhat difficult', 4 is 'easy'. As a result of this 4-grade scoring of the scale, each patient receives a score between 0-144 from the test. However, in order to facilitate the analysis of future studies on the scale, a 100-point conversion table was created by the creators of the test. baseline
Primary Disability of Arm Shoulder and Hand Disability of Arm Shoulder and Hand (DASH) was developed by the 'Institute of Work and Health Ontario and American Academy of Orthopedic Surgeons' for use in patients with upper extremity problems. DASH is a self-report scale that measures activity and participation limitations and level of disability in upper extremity disorders. The patient's symptoms and daily life activities are examined on a scale consisting of thirty questions. Grading of the scale is done with a Likert scale. For each task, the patient gives a difficulty rating between 1 and 5. These five difficulty levels are defined as 1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: not at all. A score between 0-100 (0 = no apology, 100 = maximum apology) is obtained from the scale. A high score also indicates high functional disability. The scale has a Turkish cultural adaptation. baseline
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