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

Completed

• Conditions: Idiopathic Parkinson's Disease

• Registration Number: NCT05107531
• Lead Sponsor: Hacettepe University

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-09-10
• Study First Submitted: 2021-10-18
• Study First Submitted QC: 2021-10-25
• Study First Posted: 2021-11-04
• Status Verified: 2022-02
• Primary Completion: 2022-02-05
• Study Completion: 2022-02-05
• Last Update Submitted: 2022-02-20
• Last Update Posted: 2022-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
KoreBalance Balance Evaluation System	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.
E-LINK FP3 Force Plate	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.
Time Up and Go Test	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.
Computerized Gait Assessment System (Zebris Rehawalk)	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.
Functional Reach Test	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.

Secondary Outcome Measures

Name	Time	Method
Unified Parkinson's Disease Rating Scale	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.
Freezing of Gait Questionnaire	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.

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey