Effect of Freezing Phenomenon in Patients With Parkinson's Disease

August 16, 2024 updated by: Suleyman Korkusuz, Hacettepe University

Investigation of the Effect of Freezing Phenomenon on Gait Parameters and Pedobarographic Pressure Distribution in Patients With Parkinson's Disease

Although the literature review indicates that plantar pressure may be related to freezing, there are not enough studies examining the effect of freezing phenomenon on pedobarographic pressure distribution and gait parameters. Therefore, the aim of our study is to examine the effect of freezing phenomenon on gait parameters and pedobarographic pressure distribution in patients with Parkinson's Disease.

Study Overview

Status

Completed

Conditions

Detailed Description

Individuals diagnosed with Idiopathic Parkinson's disease by a physician and healthy individuals with similar demographic characteristics will be included in the study. Individuals will be examined in 3 groups: a group of patients with Parkinson's Disease with freezing phenomenon, a group of patients with Parkinson's Disease without freezing phenomenon, and a healthy control group.

Study Type

Observational

Enrollment (Actual)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with Parkinson's disease

Description

Inclusion Criteria:

  • Volunteering to participate in the study
  • Being between stage 2-3 according to the Modified Hoehn-Yahr Staging Scale
  • Having a score of 24 or above from the Standardized Mini Mental Test

Exclusion Criteria:

  • Presence of an additional neurological or psychiatric disease other than Parkinson's disease
  • Presence of uncontrollable dyskinesia or motor fluctuations
  • Presence of postural hypotension, vision problems (that cannot be compensated with the correct lens) or vestibular disorders that may affect balance
  • Presence of cardiopulmonary diseases that may affect walking
  • Presence of orthopedic problems and inflammatory arthritis (such as fractures, osteoporosis, osteomyelitis) that may cause limitation of movement and affect gait and evaluations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy
Parkinson's patients with freezing phenomenon
Parkinson's patients without freezing phenomenon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Computerized Gait Evaluation System
Time Frame: Baseline
This system allows the measurement of spatiotemporal features of gait.
Baseline
Pressure distribution measurement platform
Time Frame: Baseline
This system allows the measurement of dynamic foot pressure distribution with the pressure distribution measurement platform integrated into the system
Baseline
Kinematic analysis
Time Frame: Baseline
Kinematic analysis of the gait can be performed with the camera support within the system.
Baseline
The freezing of gait questionnaire
Time Frame: Baseline
This scale is a scale that evaluates freezing. This scale is related to patients' experiences, especially in the last week. One article describes the frequency of freezing seen in patients.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Study Chair: Emine Nur Demircan, Msc, Hacettepe University
  • Study Chair: Ayla Fil Balkan, Assoc.Prof, Hacettepe University
  • Study Chair: Bülent Elibol, Prof.Dr., Hacettepe University
  • Principal Investigator: Süleyman Korkusuz, PhD, Atılım University
  • Study Chair: Büşra Seçkinoğulları Korkusuz, MSc, Ankara University
  • Study Chair: Ayşenur Özcan, Çankırı Karatekin University
  • Study Chair: Ferdi Yavuz, Assoc.Prof, European University of Lefke
  • Study Chair: Gül Yalçın Çakmaklı, Assoc.Prof, Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2024

Primary Completion (Actual)

July 1, 2024

Study Completion (Actual)

July 10, 2024

Study Registration Dates

First Submitted

May 6, 2024

First Submitted That Met QC Criteria

July 14, 2024

First Posted (Actual)

July 17, 2024

Study Record Updates

Last Update Posted (Actual)

August 19, 2024

Last Update Submitted That Met QC Criteria

August 16, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • e2d1895a2fd54888

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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