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

Idiopathic Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05107531
• Other study ID #: GO21/777
• Status: Completed
• Start date: September 10, 2021
• Est. completion date: February 5, 2022

Study information

• Verified date: February 2022
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 5, 2022
• Est. primary completion date: February 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Parkinson's Disease
• Parkinson Disease

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Bekkers EMJ, Dijkstra BW, Heremans E, Verschueren SMP, Bloem BR, Nieuwboer A. Balancing between the two: Are freezing of gait and postural instability in Parkinson's disease connected? Neurosci Biobehav Rev. 2018 Nov;94:113-125. doi: 10.1016/j.neubiorev.2018.08.008. Epub 2018 Aug 17. Review. — View Citation

Chee R, Murphy A, Danoudis M, Georgiou-Karistianis N, Iansek R. Gait freezing in Parkinson's disease and the stride length sequence effect interaction. Brain. 2009 Aug;132(Pt 8):2151-60. doi: 10.1093/brain/awp053. Epub 2009 May 11. — View Citation

Mezzarobba S, Grassi M, Valentini R, Bernardis P. Postural control deficit during sit-to-walk in patients with Parkinson's disease and freezing of gait. Gait Posture. 2018 Mar;61:325-330. doi: 10.1016/j.gaitpost.2018.01.032. Epub 2018 Feb 2. — View Citation

Schlenstedt C, Muthuraman M, Witt K, Weisser B, Fasano A, Deuschl G. Postural control and freezing of gait in Parkinson's disease. Parkinsonism Relat Disord. 2016 Mar;24:107-12. doi: 10.1016/j.parkreldis.2015.12.011. Epub 2015 Dec 18. — View Citation

Shah J, Pillai L, Williams DK, Doerhoff SM, Larson-Prior L, Garcia-Rill E, Virmani T. Increased foot strike variability in Parkinson's disease patients with freezing of gait. Parkinsonism Relat Disord. 2018 Aug;53:58-63. doi: 10.1016/j.parkreldis.2018.04.032. Epub 2018 May 1. — View Citation

Yang YR, Lee YY, Cheng SJ, Lin PY, Wang RY. Relationships between gait and dynamic balance in early Parkinson's disease. Gait Posture. 2008 May;27(4):611-5. Epub 2007 Sep 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Standardized Mini Mental Test	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
Other	Modified Hoehn & Yahr Scale	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
Primary	E-LINK FP3 Force Plate	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
Primary	KoreBalance Balance Evaluation System	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
Primary	Functional Reach Test	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
Primary	Time Up and Go Test	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
Primary	Computerized Gait Assessment System (Zebris Rehawalk)	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	Unified Parkinson's Disease Rating Scale	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
Secondary	Freezing of Gait Questionnaire	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