- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06122740
Reliability and Validity Studies of Turkish Version of Manual Ability Measure-36
February 3, 2024 updated by: Gulser CINBAZ, Istanbul Medeniyet University
Reliability and Validity Studies of Turkish Version of Manual Ability Measure-36 (MAM-36)
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
250
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Individuals who were diagnosed with stroke, Parkinson's or Multiple Sclerosis and had problems with manual dexterity in at least one upper extremity were included in the study.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Manual Ability Measure-36
Time Frame: baseline
|
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
|
Disability of Arm Shoulder and Hand
Time Frame: baseline
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2016
Primary Completion (Actual)
January 25, 2017
Study Completion (Actual)
June 30, 2017
Study Registration Dates
First Submitted
November 3, 2023
First Submitted That Met QC Criteria
November 3, 2023
First Posted (Actual)
November 8, 2023
Study Record Updates
Last Update Posted (Estimated)
February 6, 2024
Last Update Submitted That Met QC Criteria
February 3, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Multiple Sclerosis
- Parkinson Disease
Other Study ID Numbers
- 2663-GOA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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