Parkinson DiseaseNCT06122740
Reliability and Validity Studies of Turkish Version of Manual Ability Measure-36
An observational study of Parkinson Disease and Multiple Sclerosis, run by Istanbul Medeniyet University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Multiple Sclerosis, Stroke
- What is being tested?
- Turkish Validity and Reliability of The MAM-36 Scale
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2016to 30 Jun 2017
- How long will I take part?
- 15 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease, Multiple Sclerosis, Stroke, Upper Extremity Problem
- Being tested
- Turkish Validity and Reliability of The MAM-36 Scale
- Medical subject headings
- Parkinson Disease, Multiple Sclerosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish Validity and Reliability of The MAM-36 ScaleOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start15 Jul 2016
- Primary completion25 Jan 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (actual)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulser CINBAZ, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122740
- Sponsor's protocol ID
- 2663-GOA
- Status last verified
- Feb 2024
- First submitted
- 3 Nov 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity Studies of Turkish Version of Manual Ability Measure-36 (MAM-36)
- ClinicalTrials.gov ID
- NCT06122740
- Acronym / sponsor ID
- 2663-GOA
- Conditions
- Parkinson Disease, Multiple Sclerosis, Stroke, Upper Extremity Problem
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 15 Jul 2016 (actual)
- Primary completion
- 25 Jan 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 15 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Turkish Validity and Reliability of The MAM-36 ScaleThe 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. | Other | – |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Multiple Sclerosis, run by Istanbul Medeniyet University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manual Ability Measure-36 (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.