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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03589872
Other study ID # OrduU3
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 8, 2018
Est. completion date January 15, 2019

Study information

Verified date January 2019
Source T.C. ORDU ÜNIVERSITESI
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 53
Est. completion date January 15, 2019
Est. primary completion date December 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Sevim ACARÖZ CANDAN Ordu Altinordu

Sponsors (1)

Lead Sponsor Collaborator
T.C. ORDU ÜNIVERSITESI

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
5 minutes
Primary 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. 10 minutes
Secondary 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.
2 minutes
Secondary 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. 10 minutes
Secondary 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. 10 minutes
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