Investigation of Gait, Foot Pressure Distribution and Balance in Parkinson's Patients With Motor Freezing

February 20, 2022 updated by: Suleyman Korkusuz, Hacettepe University
Parkinson's disease is characterized by cardinal motor signs such as bradykinesia, tremor, rigidity and postural instability. In addition to these findings, motor freezing, gait disorders, posture disorders, decreased arm swings and loss of axial rotation are also seen. About 80% of the causes of falls in Parkinson's patients are due to postural instability and motor freezing, and patients' quality of life is significantly affected. In addition, gait disorders are common in advanced stages of Parkinson's Disease. Gait disorders decrease the quality of life by increasing the risk of falls, fractures and mortality. Therefore, the aim of this study is to observe the change in gait, foot pressure distribution and balance parameters of Parkinson's patients with and without motor deceleration compared to each other and healthy controls and to determine the relationship between these parameters.

Study Overview

Status

Completed

Conditions

Detailed Description

Parkinson's disease is characterized by basic motor symptoms such as bradykinesia, tremor, rigidity and postural instability. In addition to these findings, motor freezing, gait disorders, posture disorders, decreased arm swings and loss of axial rotation are also seen. Restrictions in balance, mobility and activities of daily living due to motor disorders seen in Parkinson's Disease and related disability, addiction and decrease in quality of life occur. Approximately 80% of the causes of falls in Parkinson's patients are due to postural instability and motor freezing, and the quality of life of patients is significantly affected. Also, gait disturbances are common in advanced stages of Parkinson's Disease. Gait disorders reduce the quality of life by increasing the risk of falls, fractures and death. Therefore, the aim of this study is to observe the changes in the gait, foot pressure distribution and balance parameters of Parkinson's patients with and without motor retardation compared to each other and to healthy controls, and to determine the relationship between these parameters.

This research is planned as two sub-work packages. Foot pressure distribution analysis and gait evaluation will be performed in the first sub-work package, and balance evaluation will be performed in the second sub-work package.

From the results of this research, 2 separate articles will be written that evaluate the balance and foot pressure distribution analysis and gait separately.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Parkinson's patients and healthy individuals who applied to Hacettepe University Neurology Clinic as voluntary participants will be included in this study.

Description

Inclusion Criteria:

  • Being diagnosed with idiopathic Parkinson's disease
  • Healthy individuals who do not have musculoskeletal disease or any neurological disease that may affect assessments
  • Being between 50-80 years old
  • Volunteer to participate in the study
  • Grade 2-3 on the Modified Hoehn-Yahr Scale
  • To have a score above 24 in the Standardized Mini Mental Test

Exclusion Criteria:

  • Having an additional neurological or psychiatric disease other than Parkinson's disease
  • Uncontrollable dyskinesia or motor fluctuations
  • Presence of postural hypotension, vision problems (not compensated by the correct lens) or vestibular disorders that may affect balance
  • Presence of cardiopulmonary diseases that may affect gait
  • Presence of orthopedic problems (such as fractures, osteoporosis, osteomyelitis) and inflammatory arthritis that may cause limitation of movement and affect gait and assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Parkinson's Patients with Motor Freezing
Individuals with Parkinson's Disease with motor freezing were included in this group.
Parkinson's Patients Without Motor Freeze
Individuals with Parkinson's Disease without motor freeze were included in this group.
Healthy Controls
Healthy individuals who did not have any neurological problems that would affect gait were included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
E-LINK FP3 Force Plate
Time Frame: Baseline
The system allows an accurate and objective assessment of the patient's ability to maintain postural stability on a static surface by measuring the symmetrical weight distribution in both the anterior-posterior and left-right axes. While the patient is standing on the force platform, a timed balance test is performed by the researcher to determine which direction the patient's balance has shifted.
Baseline
KoreBalance Balance Evaluation System
Time Frame: Baseline
KoreBalance is a balance assessment and training system designed with the latest technology. There is a variable air pressure pouch system and tilt sensor under the platform to monitor movements 360° horizontally and 20° vertically. There are dynamic and static balance tests in the device.
Baseline
Functional Reach Test
Time Frame: Baseline
The functional reach test is a dynamic test used to evaluate postural control. Participants are asked to reach forward through the ankle joint without moving their hips. Values less than 25.4 cm indicate an increased risk of falling.
Baseline
Time Up and Go Test
Time Frame: Baseline
The patient is asked to get up from the chair he is sitting in, walk three meters, turn around and sit again. At this time, the time is recorded. 10 seconds or less; It indicates that the patient walks independently, the risk of falling is low, and if it is longer than 30 seconds, it indicates the need for help from time to time and a high risk of falling.
Baseline
Computerized Gait Assessment System (Zebris Rehawalk)
Time Frame: Baseline
In addition to the spatiotemporal characteristics of gait such as gait speed, stride length, double stride length, stride width, cadence, stance and swing phase outputs, the pressure distribution measurement platform integrated into the system allows the measurement of dynamic foot pressure distribution. In addition, kinematic analysis of the gait can be made with the support of the camera in the system.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freezing of Gait Questionnaire
Time Frame: Baseline
The scale is a scale that evaluates motor freezing in Parkinson's patients. It is questioned whether freezing occurs during activities such as walking and turning on the 6-item scale developed. In addition, in the presence of freezing, the severity, frequency and duration of freezing are recorded.
Baseline
Unified Parkinson's Disease Rating Scale
Time Frame: Baseline
It is used to evaluate the symptoms of the disease and the complications that develop due to treatment. In this scale, which consists of 4 parts, the scoring of each item is between 0-4 points. The increase in the total score reflects the increase in the severity of the symptoms.
Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standardized Mini Mental Test
Time Frame: Baseline
There are 19 items in this test, which consists of 5 main parts: orientation, recording memory, attention and calculation, recall and language. The total score of the test is evaluated out of 30 and 24 points are accepted as the threshold value for the diagnosis of mild dementia.
Baseline
Modified Hoehn & Yahr Scale
Time Frame: Baseline
It is the most frequently used scale to classify the progression stages of Parkinson's Disease. It is widely used for reasons such as being quite simple and being able to determine the motor and functional group of the patients. It performs the staging on the basis of the unilateral or bilateral status of the disease, and the effect on balance and gait. Progression in stages is associated with worsening motor and reduced quality of life.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Study Chair: Kadriye Armutlu, Prof. Dr., Hacettepe University
  • Study Chair: Büşra Seçkinoğulları, MSc, Hacettepe University
  • Study Chair: Bülent Elibol, Prof. Dr., Hacettepe University
  • Study Chair: Emine Nur Demircan, MSc, Hacettepe University
  • Study Chair: Ayşenur Özcan, MSc, Hacettepe University
  • Study Chair: Gül Yalçın Çakmaklı, Assoc. Prof., Hacettepe University
  • Study Chair: Ferdi Yavuz, Assoc. Prof.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2021

Primary Completion (Actual)

February 5, 2022

Study Completion (Actual)

February 5, 2022

Study Registration Dates

First Submitted

October 18, 2021

First Submitted That Met QC Criteria

October 25, 2021

First Posted (Actual)

November 4, 2021

Study Record Updates

Last Update Posted (Actual)

February 22, 2022

Last Update Submitted That Met QC Criteria

February 20, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO21/777

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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