Fine Motor Skill DysfunctionNCT03589872
The Fine Motor Dexterity Under Dual Task in Parkinson's Disease
An observational study of Fine Motor Skill Dysfunction and Parkinson Disease, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to investigate the contribution of dual task interference on dexterity related ADL disability in patients with Parkinson's disease. We hypothesised that the dual task interference is an indicator of dexterity related ADL difficulties. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Fine Motor Skill Dysfunction, Parkinson Disease
- What is being tested?
- Fine motor dexterity test, nine hole peg test
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 May 2018to 15 Jan 2019
- 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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: community sample:community-dwelling patients with Parkinson disease.
Who may be able to join
- Diagnosis of idiopathic Parkinson's disease according to the criteria of the United Kingdom brain Bank by neurologist
- Age 50-90 range
- having sufficient cognitive status according to the Mini Mental Status Evaluation (24 or above from the Mini Mental Test)
Who cannot join
- Having orthopedic and neurological disorders affecting hand function,
- Having sensory problems,
- Having Diabetus mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Contribution of the Dual Task Interference on the Dexterity Related Activities of Daily Living in Parkinson's Disease
This study was planned to investigate the contribution of dual task interference on dexterity related ADL disability in patients with Parkinson's disease. We hypothesised that the dual task interference is an indicator of dexterity related ADL difficulties.
Read the detailed description
We planned this study as a cross sectional trial. 53 patients with Parkinson's disease will be evaluated under 2 different task by nine hole peg test. Besides this assessment the cardinal symptoms (bradykinesia, tremor, rigidity) will be evaluated to determine their contribution on the ADL performance.
- Conditions
- Fine Motor Skill Dysfunction, Parkinson Disease
- Being tested
- Fine motor dexterity test, nine hole peg test
- Keywords
- hand function, dual task, Parkinson disease, activities of daily living
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fine motor dexterity test, nine hole peg testDiagnostic test
The nine hole peg test will be performed under two different task (1)single task, (2)adding a cognitive task
| Study group | Role | What they receive |
|---|---|---|
| Study Group | patients with parkinson disease Receives: Diagnostic Test: Fine motor dexterity test, nine hole peg test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nine hole peg test
The Nine-Hole Peg Test is used to measure finger dexterity in patients with various neurological diagnoses. The patient must pick up the pegs from the holes and replace them back as fast as possible. The Nine Hole Peg Test should be conducted with the dominant arm first, then nondominant hand. The time will be recorded in second to complete the test. The test will be performed under three task;
- single task: Only nine-hole peg test
- adding a cognitive task: Nine-hole peg test will be performed with a concurrent cognitive task. The cognitive task is a serial 7 subtraction from numbers changed between 290 and 310 during the performing nine-hole peg test. The time will be recorded.
Measured: 5 minutes
ADL-related dexterity Questionnaire 24 (DextQ-24)
Dexterity-related ADL difficulties were measured by the ADL-related dexterity Questionnaire 24 (DextQ-24), including 24 question dealing with bimanual and unimanual activities, which is a reliable and valid disease specific questionnaire to evaluate dexterity in patients with PD. Each question is scored between 1 (no problems) and 4 (need aid to perform task) by the patient's experience. Total score ranged from 24 points to 96 points.
Measured: 10 minutes
Secondary outcomes (3)
Modified Hoehn and Yahr Scale
Disease progression will be assessed with modified Hoehn and Yahr Scale. The original scale included stages 1 through 5. Since then, stage 0 has been added, and stages 1.5 and 2.5 have been proposed. This modified scale allocates stages from 0 to 5 to indicate the relative level of disability.
Stage 0: No signs of disease.
Stage 1: Unilateral symptoms only.
Stage 1.5: Unilateral and axial involvement.
Stage 2: Bilateral symptoms. No impairment of balance.
Stage 2.5: Mild bilateral disease with recovery on pull test.
Stage 3: Balance impairment. Mild to moderate disease. Physically independent.
Stage 4: Severe disability, but still able to walk or stand unassisted.
Stage 5: Needing a wheelchair or bedridden unless assisted.
Measured: 2 minutes
Unified Parkinson's Disease Rating Scale (UPDRS) - Section of Activities of Daily Living (ADL)
The UPDRS- ADL section evaluates the impact of Parkinson disease on ADL according to patient's perspective. The ADL section consists of 13 items for gathering information on the patient's own perception of functional impairment due to PD. Each item scores between 0-4. 0 means normal and 4 means severe impairment. The total score change between 0-52. High scores indicate severe impairment.
Measured: 10 minutes
Unified Parkinson's Disease Rating Scale (UPDRS) - Motor Section
Motor section of UPDRS determines the impairment due to the Parkinson's disease. Rigidity, bradykinesia and tremor items which are relating with upper extremity function will be assessed. Each item scores between 0-4. 0 means normal and 4 means severe impairment. The total scores of rigidity, bradykinesia, and tremor, respectively range between 0-8, 0-24 and 0-16.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start8 May 2018
- Primary completion15 Dec 2018
- Study completion15 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fine Motor Skill DysfunctionStudies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevim ACARÖZ CANDAN, Ordu University
- Investigators
- SEVİM ACARÖZ CANDAN, Principal investigator, Ordu University, Department of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589872
- Sponsor's protocol ID
- OrduU3
- Status last verified
- Jan 2019
- First submitted
- 5 Jul 2018
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contribution of the Dual Task Interference on the Dexterity Related Activities of Daily Living in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03589872
- Acronym / sponsor ID
- OrduU3
- Conditions
- Fine Motor Skill Dysfunction, Parkinson Disease
- Keywords
- hand function, dual task, Parkinson disease, activities of daily living
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 8 May 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 15 Jan 2019 (estimated)
- First posted
- 18 Jul 2018 (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 was planned to investigate the contribution of dual task interference on dexterity related ADL disability in patients with Parkinson's disease. We hypothesised that the dual task interference is an indicator of dexterity related ADL difficulties.
Detailed description
We planned this study as a cross sectional trial. 53 patients with Parkinson's disease will be evaluated under 2 different task by nine hole peg test. Besides this assessment the cardinal symptoms (bradykinesia, tremor, rigidity) will be evaluated to determine their contribution on the ADL performance.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Diagnostic Test: Fine motor dexterity test, nine hole peg testpatients with parkinson disease |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- community sample:community-dwelling patients with Parkinson disease.
Key inclusion criteria (3 listed)
- Diagnosis of idiopathic Parkinson's disease according to the criteria of the United Kingdom brain Bank by neurologist
- Age 50-90 range
- having sufficient cognitive status according to the Mini Mental Status Evaluation (24 or above from the Mini Mental Test)
Key exclusion criteria (3 listed)
- Having orthopedic and neurological disorders affecting hand function,
- Having sensory problems,
- Having Diabetus mellitus
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 |
|---|---|---|
| Fine motor dexterity test, nine hole peg testThe nine hole peg test will be performed under two different task (1)single task, (2)adding a cognitive task | Diagnostic test | Study Group |
Primary outcome
Nine hole peg test
Time frame: 5 minutes
The Nine-Hole Peg Test is used to measure finger dexterity in patients with various neurological diagnoses. The patient must pick up the pegs from the holes and replace them back as fast as possible. The Nine Hole Peg Test should be conducted with the dominant arm first, then nondominant hand. The time will be recorded in second to complete the test. The test will be performed under three task; 1. single task: Only nine-hole peg test 2. adding a cognitive task: Nine-hole peg test will be performed with a concurrent cognitive task. The cognitive task is a serial 7 subtraction from numbers changed between 290 and 310 during the performing nine-hole peg test. The time will be recorded.
ADL-related dexterity Questionnaire 24 (DextQ-24)
Time frame: 10 minutes
Dexterity-related ADL difficulties were measured by the ADL-related dexterity Questionnaire 24 (DextQ-24), including 24 question dealing with bimanual and unimanual activities, which is a reliable and valid disease specific questionnaire to evaluate dexterity in patients with PD. Each question is scored between 1 (no problems) and 4 (need aid to perform task) by the patient's experience. Total score ranged from 24 points to 96 points.
3 secondary outcomes
Modified Hoehn and Yahr Scale
Time frame: 2 minutes
Unified Parkinson's Disease Rating Scale (UPDRS) - Section of Activities of Daily Living (ADL)
Time frame: 10 minutes
Unified Parkinson's Disease Rating Scale (UPDRS) - Motor Section
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
Related trials for Fine Motor Skill Dysfunction
Recruiting
Comparison of the Effects of Bimanual, Finger and VR Exercises in PwMCI
Mild Cognitive Impairment
Not yet recruiting
Sensory Mechanisms of Manual Dexterity Recovery After Stroke: a Prospective Cohort Study of Prediction and Cerebral Correlates
Stroke, Upper Extremity Paresis
Recruiting
The Efficacy of a Technology-Assisted Block Training Program on Cognitive Function, Hand Dexterity, and Grip Strength in Community-Dwelling Older Adults: A Mixed-Methods Research
Community-Dwelling Older Adults, Aging
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.
SEVİM ACARÖZ CANDAN principal investigator
Ordu University, Department of Physiotherapy and Rehabilitation
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 Fine Motor Skill Dysfunction and Parkinson Disease, run by Ordu 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: status not confirmed, as of the sponsor's last update on 15 Jan 2019. 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?
Results are not available in the source record.
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?
Nine hole peg test (time frame: 5 minutes). 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 15 Jan 2019.