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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04420910
• Other study ID #: 2019-71
• Status: Completed
• Start date: April 15, 2019
• Est. completion date: September 15, 2019

Study information

• Verified date: June 2020
• Source: Ankara Yildirim Beyazit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 15, 2019
• Est. primary completion date: August 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Balance
• Mobility
• Muscle Strength
• Non-motor Symptoms
• Parkinson Disease

Intervention

Other:
• 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.
• 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.
• 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 90? flexion and 0? extension angles. The individual was asked to perform it with the maximum strength, while the therapist motivated the individual with verbal stimulation.
• 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.

Locations

Country	Name	City	State
Turkey	Ankara Yildirim Beyazit University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation	Ankara	Esenboga

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Yildirim Beyazit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-Motor Symptoms	Non-motor symptoms of the participants were evaluated using the Non-Motor Symptoms Scale (NMSS).Each item of the scale is scored between 0 and 30, with "yes" 1 point and "no" 0 point. According to the scoring result, "0" indicates no NMSs, "1-5" indicates mild NMSs, "6-9" indicates medium NMSs, "10-13" indicates heavy NMSs, and "=14" indicates very heavy NMSs.	one hour
Primary	Balance	To measure balance, the Biodex Balance System (Biodex Medical Systems, Shirley, NY, USA) was used.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. As a result, overall stability and anteroposterior and mediolateral indexes were taken into account, and low values indicate high postural stability.	one hour
Primary	Lower limb strength	A Biodex® System 4 Dynamometer device was used to evaluate muscle strength.Maximal concentric knee flexion and extension muscle strength was measured at 90 degrees/sec angular velocity with 5 repetition [19]. The flexion and extension peak torque (PT) values, peak torque/body weight (PT/BW) ratio, and hamstring/quadriceps (H/Q) ratio were recorded. Low values indicate decreased muscle strength.	one hour
Primary	Functional mobility	The Timed Up and Go test (TUG) was used in the evaluation of functional mobility. Dual task performance was performed by adding cognitive and motor tasks into the TUG.. As the time increases, dual task performance decreases.	one hour