Skip to main content
OpenTrials
Completed

NCT Number: NCT05107531

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 4, 2021
Registry last updated
Feb 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.