Non-motor Symptoms, Balance, Muscle Strength, and Functional Mobility in Patients With Parkinson's Disease

NCT ID: NCT04420910

Last Updated: 2020-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-15

Study Completion Date

2019-09-15

Brief Summary

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The purposes of this study is to examine balance, muscle strength, and mobility in relation with non-motor symptoms (NMSs) in patients with Parkinsosn's Disease (PD).

NMSs have been shown to be the key determinant of health-related quality of life (HRQoL) and have a greater effect on HRQoL compared to motor symptoms.Despite a growing literature on NMSs, there are few data on the association between NMSs and motor phenotypes of PD, and they have usually focused only on specific domains of NMSs, such as cognition, mood/anxiety issues, or sleep disorders.

When literature is examined, there is no study which examines balance, muscle strength, and mobility in relation with NMSs in patients with PD.For all these reasons, we think that balance, muscle strength, mobility, and NMSs in patients with PD are worse than those of the healthy individuals and that there is a relationship between NMSs and motor symptoms.

Detailed Description

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Conditions

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Parkinson Disease Balance Muscle Strength Mobility Non-motor Symptoms

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Parkinson's disease group

being diagnosed with PD by a neurologist, being in Hoehn \& Yahr Stage 1-3

Non-Motor Symptoms

Intervention Type OTHER

NMSs of the participants were evaluated using the Non-Motor Symptoms Scale (NMSS). The scale consists of 30 yes-no questions and is administered face to face with the therapist.

Balance

Intervention Type OTHER

To measure balance, the Biodex Balance System (Biodex Medical Systems, Shirley, NY, USA) was used. The participants were asked to position themselves in a comfortable position on the platform, and their foot position coordinates were recorded. The participants focused on a characteristic dot on the monitor screen. Their task was to balance the body in such a way that the dot was in the center of a circle displayed on the monitor at the point of intersection of the coordinate axes. The test consisted of three 20 s trials, each separated by 10 s breaks. Measurements were conducted while their eyes were open and close, and the results were analyzed by calculating the average value of the measurements.

Lower Limb Strength

Intervention Type OTHER

A Biodex® System 4 Dynamometer device was used to evaluate muscle strength. The participants' dominant extremity was determined by asking them the foot with which they most often hit the ball.The dynamometer arm of the device was placed at the lateral condyle level of the knee, and the belt at the distal end of the dynamometer was attached to the lower leg on the malleolus. Knee flexion and extension movements were evaluated in sitting position between 90ᵒ flexion and 0ᵒ extension angles. The individual was asked to perform it with the maximum strength, while the therapist motivated the individual with verbal stimulation.

Functional mobility

Intervention Type OTHER

The Timed Up and Go test (TUG) was used in the evaluation of functional mobility. . For this test, participants were seated on a standard armless chair and a cone was placed 3 meters away from the chair. Participants were instructed to stand up and (1) walk towards the cone, (2) turn around the cone, (3) walk back to the chair, and (4) sit back on the chair. It was stated that patients should walk without running but as fast as possible. Dual task performance was performed by adding cognitive and motor tasks into the TUG.

Healthy group

20 healthy volunteers with matching ages and genders.

Non-Motor Symptoms

Intervention Type OTHER

NMSs of the participants were evaluated using the Non-Motor Symptoms Scale (NMSS). The scale consists of 30 yes-no questions and is administered face to face with the therapist.

Balance

Intervention Type OTHER

To measure balance, the Biodex Balance System (Biodex Medical Systems, Shirley, NY, USA) was used. The participants were asked to position themselves in a comfortable position on the platform, and their foot position coordinates were recorded. The participants focused on a characteristic dot on the monitor screen. Their task was to balance the body in such a way that the dot was in the center of a circle displayed on the monitor at the point of intersection of the coordinate axes. The test consisted of three 20 s trials, each separated by 10 s breaks. Measurements were conducted while their eyes were open and close, and the results were analyzed by calculating the average value of the measurements.

Lower Limb Strength

Intervention Type OTHER

A Biodex® System 4 Dynamometer device was used to evaluate muscle strength. The participants' dominant extremity was determined by asking them the foot with which they most often hit the ball.The dynamometer arm of the device was placed at the lateral condyle level of the knee, and the belt at the distal end of the dynamometer was attached to the lower leg on the malleolus. Knee flexion and extension movements were evaluated in sitting position between 90ᵒ flexion and 0ᵒ extension angles. The individual was asked to perform it with the maximum strength, while the therapist motivated the individual with verbal stimulation.

Functional mobility

Intervention Type OTHER

The Timed Up and Go test (TUG) was used in the evaluation of functional mobility. . For this test, participants were seated on a standard armless chair and a cone was placed 3 meters away from the chair. Participants were instructed to stand up and (1) walk towards the cone, (2) turn around the cone, (3) walk back to the chair, and (4) sit back on the chair. It was stated that patients should walk without running but as fast as possible. Dual task performance was performed by adding cognitive and motor tasks into the TUG.

Interventions

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Non-Motor Symptoms

NMSs of the participants were evaluated using the Non-Motor Symptoms Scale (NMSS). The scale consists of 30 yes-no questions and is administered face to face with the therapist.

Intervention Type OTHER

Balance

To measure balance, the Biodex Balance System (Biodex Medical Systems, Shirley, NY, USA) was used. The participants were asked to position themselves in a comfortable position on the platform, and their foot position coordinates were recorded. The participants focused on a characteristic dot on the monitor screen. Their task was to balance the body in such a way that the dot was in the center of a circle displayed on the monitor at the point of intersection of the coordinate axes. The test consisted of three 20 s trials, each separated by 10 s breaks. Measurements were conducted while their eyes were open and close, and the results were analyzed by calculating the average value of the measurements.

Intervention Type OTHER

Lower Limb Strength

A Biodex® System 4 Dynamometer device was used to evaluate muscle strength. The participants' dominant extremity was determined by asking them the foot with which they most often hit the ball.The dynamometer arm of the device was placed at the lateral condyle level of the knee, and the belt at the distal end of the dynamometer was attached to the lower leg on the malleolus. Knee flexion and extension movements were evaluated in sitting position between 90ᵒ flexion and 0ᵒ extension angles. The individual was asked to perform it with the maximum strength, while the therapist motivated the individual with verbal stimulation.

Intervention Type OTHER

Functional mobility

The Timed Up and Go test (TUG) was used in the evaluation of functional mobility. . For this test, participants were seated on a standard armless chair and a cone was placed 3 meters away from the chair. Participants were instructed to stand up and (1) walk towards the cone, (2) turn around the cone, (3) walk back to the chair, and (4) sit back on the chair. It was stated that patients should walk without running but as fast as possible. Dual task performance was performed by adding cognitive and motor tasks into the TUG.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* being diagnosed with PD by a neurologist, being in Hoehn \& Yahr Stage 1-3, having no musculoskeletal system problems in the previous 6 months, having a score of 24 or more in the Mini-Mental State Examination (MMSE), and being volunteer.

Exclusion Criteria

* Healthy individuals of similar age and sex, without neurological problems, and who did not experience any musculoskeletal system problems in the previous 6 months were included in the control group.
Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara Yildirim Beyazıt University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ankara Yıldırım Beyazıt University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation

Ankara, Esenboğa, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2019-71

Identifier Type: -

Identifier Source: org_study_id

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