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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 50 to 65 years
• All sexes
• Healthy volunteers accepted
• Adult, Older adult

Study population: being diagnosed with PD by a neurologist, being in Hoehn \& Yahr Stage 1-3 and healthy individuals of similar age and sex

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

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

Being tested

Non-Motor Symptoms, Balance, Lower Limb Strength, Functional mobility

Medical subject headings

Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Non-Motor SymptomsOther

  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.

• BalanceOther

  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 StrengthOther

  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 mobilityOther

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: one hour

2. 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.

   Measured: one hour

3. 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.

   Measured: one hour

4. 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.

   Measured: one hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted9 Jun 2020
2. Study start15 Apr 2019
3. Primary completion15 Aug 2019
4. Study completion15 Sep 2019

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
• More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.