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

NCT05107531 | Completed

• 1 other identifier: GO21/777
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Parkinson's Disease

Keywords

Postural Balance; Parkinson's Disease; Gait Analysis; Kinematic Analysis; Motor Freezing; Spatio-Temporal Analysis; Foot Pressure Distribution

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Unified Parkinson's Disease Rating Scale

  Baseline

• Freezing of Gait Questionnaire

  Baseline

Other Outcomes (2)

• Standardized Mini Mental Test

  Baseline

• Modified Hoehn & Yahr Scale

  Baseline

Study Arms (3)

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.

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 26762797 BACKGROUND

• 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.

  PMID: 29413805 BACKGROUND

• 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.

  PMID: 30125601 BACKGROUND

• 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.

  PMID: 29773512 BACKGROUND

• 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.

  PMID: 19433440 BACKGROUND

• 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. doi: 10.1016/j.gaitpost.2007.08.003. Epub 2007 Sep 24.

  PMID: 17890091 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Kadriye Armutlu, Prof. Dr.

  Hacettepe University

  STUDY CHAIR

• Süleyman Korkusuz, MSc

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Emine Nur Demircan, MSc

  Hacettepe University

  STUDY CHAIR

• Ayşenur Özcan, MSc

  Hacettepe University

  STUDY CHAIR

• Büşra Seçkinoğulları, MSc

  Hacettepe University

  STUDY CHAIR

• Gül Yalçın Çakmaklı, Assoc. Prof.

  Hacettepe University

  STUDY CHAIR

• Bülent Elibol, Prof. Dr.

  Hacettepe University

  STUDY CHAIR

• Ferdi Yavuz, Assoc. Prof.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: November 4, 2021
• Study Start: September 10, 2021
• Primary Completion: February 5, 2022
• Study Completion: February 5, 2022
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)