The Quality of Life in Individuals With Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

A Cross-sectional Study - The Quality of Life in Individuals With Parkinson's Disease: Is it Related to Functionality and Tremor Severity?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05906693
• Other study ID #: 60116787-020/45991
• Secondary ID: 2019SABE021
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: July 13, 2021

Study information

• Verified date: June 2023
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aimed to examine the relationship of quality of life with tremor severity and upper limb functionality in individuals with Parkinson's Disease. The differences between Parkinson's Disease Quality of Life Questionnaire, Nine-Hole Peg Test, grip and pinch strength values in the individuals with and without tremor in the study were investigated.

Description:

Evaluating the relationship between Quality of Life and tremor is needed to determine the best physiotherapy and rehabilitation approaches for individuals with Parkinson's Disease. This study aimed to examine the relationship of quality of life with tremor severity and upper limb functionality in individuals with Parkinson's Disease. Fifty-two individuals with Parkinson's Disease participated in the study. Quality of Life, tremor amplitude, upper limb functionality, grip and pinch strength were evaluated. The relationship of quality of life with tremor severity and upper limb functionality was examined in individuals with Parkinson's Disease. The results of individuals with and without tremor were compared.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 13, 2021
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Definite diagnosis of idiopathic Parkinson Disease

• Age between 40 and 80 years

• Being literate

• Having a grade between 1-4 from the Modified Hoehn and Yahr Scale

• Having a score lower than 11 in Hospital Anxiety and Depression Scale

Exclusion Criteria:

• Who were with any other neurologic or orthopedic or rheumatologic disease affecting the upper extremity

• Using antidepressants

• Having vision loss

• Deep brain stimulation

Related Conditions & MeSH terms

• Functionality
• Parkinson Disease
• Tremor

Intervention

Other:
• Quality of life
Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
• Upper limb functionality
Nine-Hole Peg Test
• Grip and pinch strength
Dynamometer
• Tremor amplitude
Electromyography
• Depression and anxiety levels
Hospital Anxiety and Depression Scale
• Clinical manifestations
The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli	Pamukkale

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Bhatia KP, Bain P, Bajaj N, Elble RJ, Hallett M, Louis ED, Raethjen J, Stamelou M, Testa CM, Deuschl G; Tremor Task Force of the International Parkinson and Movement Disorder Society. Consensus Statement on the classification of tremors. from the task force on tremor of the International Parkinson and Movement Disorder Society. Mov Disord. 2018 Jan;33(1):75-87. doi: 10.1002/mds.27121. Epub 2017 Nov 30. — View Citation

Kuhlman GD, Flanigan JL, Sperling SA, Barrett MJ. Predictors of health-related quality of life in Parkinson's disease. Parkinsonism Relat Disord. 2019 Aug;65:86-90. doi: 10.1016/j.parkreldis.2019.05.009. Epub 2019 May 7. — View Citation

Louis ED, Machado DG. Tremor-related quality of life: A comparison of essential tremor vs. Parkinson's disease patients. Parkinsonism Relat Disord. 2015 Jul;21(7):729-35. doi: 10.1016/j.parkreldis.2015.04.019. Epub 2015 Apr 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale	The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale. Used for the evaluation of clinical manifestations of Parkinson's disease. The scale consists of 4 subscales: the first part is Non-Motor Aspects of Experiences of Daily Living (13), the second part is Motor Aspects of Experiences of Daily Living (13), the third part is Motor Examination (33), and the fourth part is Motor Complications (6). The total number of items in the scale is 65. The minimum score is 0. The maximum MDS-UPDRS score is higher, given the additional items and scores for each body area, with a maximum score of 272. Higher scores indicate greater impact of Parkinson Disease symptoms.	1 year
Primary	Hospital Anxiety and Depression Scale	The Hospital Anxiety and Depression Scale aims to measure symptoms of anxiety and depression and consists of 14 items, seven items for the anxiety subscale (Hospital Anxiety and Depression Scale Anxiety) and seven for the depression subscale (Hospital Anxiety and Depression Scale Depression). Each item is scored on a response-scale with four alternatives ranging between 0 and 3. After adjusting for six items that are reversed scored, all responses are summed to obtain the two subscales. Both depression and anxiety subheadings are scored between 0 and 21. Higher scores indicate greater levels of anxiety or depression. Cut-off scores are 8-10 for doubtful cases and =11 for definite cases.	1 year
Primary	Parkinson's Disease Quality of Life Questionnaire (PDQ-39)	Used to assess the quality of life of Parkinson's patients	1 year
Primary	Electromyography	Used to assess the tremor amplitude of Parkinson's patients	1 year
Primary	Nine-Hole Peg Test	Used to assess the upper limb functionality of Parkinson's patients	1 year
Primary	Dynamometer	Used to assess the grip and pinch strength of Parkinson's patients	1 year