Clinical trial NCT05107531: Investigation of Gait, Foot Pressure Distribution and Balance in Parkinson's Patients With Motor Freezing
Official title: Investigation of Gait, Foot Pressure Distribution and Balance in Parkinson's Patients With Motor Freezing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Parkinson's Disease
Keywords: Postural Balance
Parkinson's Disease
Gait Analysis
Kinematic Analysis
Motor Freezing
Spatio-Temporal Analysis
Foot Pressure Distribution
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: E-LINK FP3 Force Plate
timeFrame: Baseline
measure: KoreBalance Balance Evaluation System
timeFrame: Baseline
measure: Functional Reach Test
timeFrame: Baseline
measure: Time Up and Go Test
timeFrame: Baseline
measure: Computerized Gait Assessment System (Zebris Rehawalk)
timeFrame: Baseline
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale
timeFrame: Baseline
measure: Freezing of Gait Questionnaire
timeFrame: Baseline
Other outcomes:
measure: Standardized Mini Mental Test
timeFrame: Baseline
measure: Modified Hoehn & Yahr Scale
timeFrame: Baseline
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Kadriye Armutlu, Prof. Dr.
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Süleyman Korkusuz, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Emine Nur Demircan, MSc
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Ayşenur Özcan, MSc
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Büşra Seçkinoğulları, MSc
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Gül Yalçın Çakmaklı, Assoc. Prof.
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Bülent Elibol, Prof. Dr.
role: STUDY_CHAIR
name: Ferdi Yavuz, Assoc. Prof.
role: STUDY_CHAIR
References:
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.
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.
citation: 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.
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.
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.
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. doi: 10.1016/j.gaitpost.2007.08.003. Epub 2007 Sep 24.