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

NCT ID: NCT05107531

Last Updated: 2022-02-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-10
• Study Completion Date: 2022-02-05

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.

Conditions

Idiopathic Parkinson's Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Parkinson's Patients with Motor Freezing

Individuals with Parkinson's Disease with motor freezing were included in this group.

No interventions assigned to this group

Parkinson's Patients Without Motor Freeze

Individuals with Parkinson's Disease without motor freeze were included in this group.

No interventions assigned to this group

Healthy Controls

Healthy individuals who did not have any neurological problems that would affect gait were included.

No interventions assigned to this group

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Suleyman Korkusuz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kadriye Armutlu, Prof. Dr.

Role: STUDY_CHAIR

Hacettepe University

Süleyman Korkusuz, MSc

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Emine Nur Demircan, MSc

Role: STUDY_CHAIR

Hacettepe University

Ayşenur Özcan, MSc

Role: STUDY_CHAIR

Hacettepe University

Büşra Seçkinoğulları, MSc

Role: STUDY_CHAIR

Hacettepe University

Gül Yalçın Çakmaklı, Assoc. Prof.

Role: STUDY_CHAIR

Hacettepe University

Bülent Elibol, Prof. Dr.

Role: STUDY_CHAIR

Hacettepe University

Ferdi Yavuz, Assoc. Prof.

Role: STUDY_CHAIR

Locations

Hacettepe University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 26762797 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29413805 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30125601 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29773512 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19433440 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17890091 (View on PubMed)

Other Identifiers

GO21/777

Identifier Type: -

Identifier Source: org_study_id