The Fine Motor Dexterity Under Dual Task in Parkinson's Disease

January 14, 2019 updated by: Sevim ACARÖZ CANDAN, T.C. ORDU ÜNİVERSİTESİ

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Altinordu
      • Ordu, Altinordu, Turkey, 52100
        • Sevim ACARÖZ CANDAN

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

community sample:community-dwelling patients with Parkinson disease.

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Having orthopedic and neurological disorders affecting hand function,
  • Having sensory problems,
  • Having Diabetus mellitus

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Study Group
patients with parkinson disease
Diagnostic test: Fine motor dexterity test, nine hole peg test
The nine hole peg test will be performed under two different task (1)single task, (2)adding a cognitive task

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
5 minutes
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.
10 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Unified Parkinson's Disease Rating Scale (UPDRS) - Section of Activities of Daily Living (ADL)
Time Frame: 10 minutes
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.
10 minutes
Modified Hoehn and Yahr Scale
Time Frame: 2 minutes

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.
2 minutes
Unified Parkinson's Disease Rating Scale (UPDRS) - Motor Section
Time Frame: 10 minutes
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.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
T.C. ORDU ÜNİVERSİTESİ

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: SEVİM ACARÖZ CANDAN, Ordu University, Department of Physiotherapy and Rehabilitation

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 8, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OrduU3

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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