Parkinson DiseaseNCT06713707
Investigation of Validity and Reliability of the Minnesota Manual Dexterity Test in Parkinson's Disease
An observational study of Parkinson Disease, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Parkinson's Disease (PD) is a disease that affects upper extremity functional skills with clinical findings such as bradykinesia, rigidity, and hypokinesia, and causes limitations in patients' daily life activities. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Manuel dexterity and Manual Dexterity (only MMDT)
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Nov 2024to 15 Jan 2025
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Parkinson's disease who apply to Sivas Cumhuriyet University, Department of Physiotherapy and Rehabilitation will be invited to this study.
Who may be able to join
- Between 40-80 years old
- Diagnosed with only "Parkinson's Disease" by a neurologist
- Between 1-3 values of your thoughts according to Hoehn and Yahr manufacturers
Who cannot join
- Having any vision, hearing or perception problems that may affect the research results,
- Having an orthopedic problem that may affect manual skills in the upper extremity,
- Having a cardiovascular, pulmonary disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sivas Cumhuriyet University
Sivas, Sivas/Center
About this study
Official title: Investigation of Validity and Reliability of the Minnesota Manual Dexterity Test in Patients with Parkinson's Disease
Parkinson's Disease (PD) is a disease that affects upper extremity functional skills with clinical findings such as bradykinesia, rigidity, and hypokinesia, and causes limitations in patients' daily life activities. The impairment of upper extremity functional skills is related to the deficiency in planning both voluntary and complex movements, as well as the deficiency in multiple motor planning. In particular; fine manual dexterity, reaching, and grasping movements are affected, greatly affecting patients' daily activities. Therefore, upper extremity evaluations are an important issue to consider for training upper extremity motor skills in PD. There are minimal assessment tools for evaluating the upper extremity functions of individuals with PD. The Nine-Hole Peg Test and the Jebsen Hand Function Evaluation Test are the most commonly used scales in the evaluation of the upper extremity in PD, and their validity and reliability have been demonstrated. These scales roughly evaluate both extremities separately. However, these scales are not suitable assessment tools for testing activities in which both extremities are frequently used in daily life. Therefore, there is a need for valid and reliable scales that can evaluate upper extremity activities both in isolation and bilaterally. The Minnesota manual dexterity test (MMDT) allows both hands to be evaluated together. It also evaluates hand-eye coordination and gross motor skills in addition to manual dexterity. MMDT is used in individuals with PD, but there is no study in the literature examining the validity and reliability of the scale. Therefore, this study aims to evaluate the reliability and validity of MMDT in individuals with PD.
Read the detailed description
At baseline, the MMDT, 9-hole peg test, and Jebsen-Taylor Hand Function Test (JTHFT) will be applied to the MS group. The MMDT will be repeated seven days after the first application in MS. Healthy controls are going to perform only the MMDT.
- Conditions
- Parkinson Disease
- Being tested
- Manuel dexterity, Manual Dexterity (only MMDT)
- Keywords
- Parkinson's disease, Minnesota manual dexterity, Validity, Reliability, upper limb function
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manuel dexterityOther
Individuals who meet the inclusion criteria will be evaluated for manual dexterity using 9-HPT, and JTHFT.
Manual Dexterity (only MMDT)Other
Individuals who meet the inclusion criteria will be evaluated for manual dexterity using MMDT on a predetermined day.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Patients with Parkinson's disease Receives: Other: Manuel dexterity; Other: Manual Dexterity (only MMDT) | |
| Control Group | Healthy group Receives: Other: Manual Dexterity (only MMDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minnesota Manual Dexterity Test
The Minnesota Manual Dexterity Test (MMDT) is a performance test designed to evaluate hand functions and hand-eye coordination both unilaterally and bilaterally, higher scores mean a worse outcome
Measured: baseline (on the predetermined assessment day)
Minnesota Manual Dexterity Test-second
The Minnesota Manual Dexterity Test (MMDT) is a performance test designed to evaluate hand functions and hand-eye coordination both unilaterally and bilaterally, higher scores mean a worse outcome
Measured: the second assessment will be conducted after the one week
Secondary outcomes (2)
9-Hole Peg Test
The 9-Hole Peg Test (9-HPT) evaluates hand dexterity based on performance, higher scores mean a worse outcome
Measured: baseline (on the predetermined assessment day)
The Jebsen Hand Function Test
The Jebsen Hand Function Test (JHFT) is one of the objective and standardized tests that assesses fine motor skills and functional hand use by simulating daily living activities, higher scores mean a worse outcome
Measured: baseline (on the predetermined assessment day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start28 Nov 2024
- Primary completion10 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Collaborators
- Cumhuriyet University
- Responsible party
- Principal investigator, Sefa Eldemir, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713707
- Sponsor's protocol ID
- 7-PD-Minnesota-validity
- Status last verified
- Nov 2024
- First submitted
- 27 Nov 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Earhart GM, Cavanaugh JT, Ellis T, Ford MP, Foreman KB, Dibble L. The 9-hole PEG test of upper extremity function: average values, test-retest reliability, and factors contributing to performance in people with Parkinson disease. J Neurol Phys Ther. 2011 Dec;35(4):157-63. doi: 10.1097/NPT.0b013e318235da08.
PubMed 22020457Mak MK, Lau ET, Tam VW, Woo CW, Yuen SK. Use of Jebsen Taylor Hand Function Test in evaluating the hand dexterity in people with Parkinson's disease. J Hand Ther. 2015 Oct-Dec;28(4):389-94; quiz 395. doi: 10.1016/j.jht.2015.05.002. Epub 2015 May 18.
PubMed 26227308Ovacik U, Tarakci E, Gungor F, Menengic KN, Leblebici G, Acar ZO, Soysal A. The minnesota manual dexterity test as a bimanual performance measure in people with multiple sclerosis. Mult Scler Relat Disord. 2022 Aug;64:103943. doi: 10.1016/j.msard.2022.103943. Epub 2022 Jun 6.
PubMed 35738113
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Validity and Reliability of the Minnesota Manual Dexterity Test in Patients with Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06713707
- Acronym / sponsor ID
- 7-PD-Minnesota-validity
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, Minnesota manual dexterity, Validity, Reliability, upper limb function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Collaborators
- Cumhuriyet University
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 3 Dec 2024 (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.
Parkinson's Disease (PD) is a disease that affects upper extremity functional skills with clinical findings such as bradykinesia, rigidity, and hypokinesia, and causes limitations in patients' daily life activities. The impairment of upper extremity functional skills is related to the deficiency in planning both voluntary and complex movements, as well as the deficiency in multiple motor planning. In particular; fine manual dexterity, reaching, and grasping movements are affected, greatly affecting patients' daily activities. Therefore, upper extremity evaluations are an important issue to consider for training upper extremity motor skills in PD. There are minimal assessment tools for evaluating the upper extremity functions of individuals with PD. The Nine-Hole Peg Test and the Jebsen Hand Function Evaluation Test are the most commonly used scales in the evaluation of the upper extremity in PD, and their validity and reliability have been demonstrated. These scales roughly evaluate both extremities separately. However, these scales are not suitable assessment tools for testing activities in which both extremities are frequently used in daily life. Therefore, there is a need for valid and reliable scales that can evaluate upper extremity activities both in isolation and bilaterally. The Minnesota manual dexterity test (MMDT) allows both hands to be evaluated together. It also evaluates hand-eye coordination and gross motor skills in addition to manual dexterity. MMDT is used in individuals with PD, but there is no study in the literature examining the validity and reliability of the scale. Therefore, this study aims to evaluate the reliability and validity of MMDT in individuals with PD.
Detailed description
At baseline, the MMDT, 9-hole peg test, and Jebsen-Taylor Hand Function Test (JTHFT) will be applied to the MS group. The MMDT will be repeated seven days after the first application in MS. Healthy controls are going to perform only the MMDT.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | – | Other: Manuel dexterity, Other: Manual Dexterity (only MMDT)Patients with Parkinson's disease |
| Control Group | – | Other: Manual Dexterity (only MMDT)Healthy group |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's disease who apply to Sivas Cumhuriyet University, Department of Physiotherapy and Rehabilitation will be invited to this study.
Key inclusion criteria (3 listed)
- Between 40-80 years old
- Diagnosed with only "Parkinson's Disease" by a neurologist
- Between 1-3 values of your thoughts according to Hoehn and Yahr manufacturers
Key exclusion criteria (3 listed)
- Having any vision, hearing or perception problems that may affect the research results,
- Having an orthopedic problem that may affect manual skills in the upper extremity,
- Having a cardiovascular, pulmonary disorder
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 |
|---|---|---|
| Manuel dexterityIndividuals who meet the inclusion criteria will be evaluated for manual dexterity using 9-HPT, and JTHFT. | Other | Test Group |
| Manual Dexterity (only MMDT)Individuals who meet the inclusion criteria will be evaluated for manual dexterity using MMDT on a predetermined day. | Other | Control Group, Test Group |
Primary outcome
Minnesota Manual Dexterity Test
Time frame: baseline (on the predetermined assessment day)
The Minnesota Manual Dexterity Test (MMDT) is a performance test designed to evaluate hand functions and hand-eye coordination both unilaterally and bilaterally, higher scores mean a worse outcome
Minnesota Manual Dexterity Test-second
Time frame: the second assessment will be conducted after the one week
The Minnesota Manual Dexterity Test (MMDT) is a performance test designed to evaluate hand functions and hand-eye coordination both unilaterally and bilaterally, higher scores mean a worse outcome
2 secondary outcomes
9-Hole Peg Test
Time frame: baseline (on the predetermined assessment day)
The Jebsen Hand Function Test
Time frame: baseline (on the predetermined assessment day)
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 28 Jan 2025.
- Background: PubMed 22020457Earhart GM, Cavanaugh JT, Ellis T, Ford MP, Foreman KB, Dibble L. The 9-hole PEG test of upper extremity function: average values, test-retest reliability, and factors contributing to performance in people with Parkinson disease. J Neurol Phys Ther. 2011 Dec;35(4):157-63. doi: 10.1097/NPT.0b013e318235da08.
- Background: PubMed 26227308Mak MK, Lau ET, Tam VW, Woo CW, Yuen SK. Use of Jebsen Taylor Hand Function Test in evaluating the hand dexterity in people with Parkinson's disease. J Hand Ther. 2015 Oct-Dec;28(4):389-94; quiz 395. doi: 10.1016/j.jht.2015.05.002. Epub 2015 May 18.
- Background: PubMed 35738113Ovacik U, Tarakci E, Gungor F, Menengic KN, Leblebici G, Acar ZO, Soysal A. The minnesota manual dexterity test as a bimanual performance measure in people with multiple sclerosis. Mult Scler Relat Disord. 2022 Aug;64:103943. doi: 10.1016/j.msard.2022.103943. Epub 2022 Jun 6.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Gazi University at 1 site in Turkey (Türkiye).
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 3 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 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Minnesota Manual Dexterity Test (time frame: baseline (on the predetermined assessment day)). 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?
On the ClinicalTrials.gov record for NCT06713707, which also lists 3 linked publications.
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 28 Jan 2025.