Patients With Parkinson's DiseaseNCT06505343
Effect of Freezing Phenomenon in Patients With Parkinson's Disease
An observational study of Patients With Parkinson's Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Patients With Parkinson's Disease
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 May 2024to 10 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Parkinson's disease
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Patients With Parkinson's Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's patients with freezing phenomenon | Parkinson's patients with freezing phenomenon | |
| Parkinson's patients without freezing phenomenon | Parkinson's patients without freezing phenomenon | |
| Healthy | Healthy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Computerized Gait Evaluation System
This system allows the measurement of spatiotemporal features of gait.
Measured: Baseline
Pressure distribution measurement platform
This system allows the measurement of dynamic foot pressure distribution with the pressure distribution measurement platform integrated into the system
Measured: Baseline
Kinematic analysis
Kinematic analysis of the gait can be performed with the camera support within the system.
Measured: Baseline
The freezing of gait questionnaire
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start6 May 2024
- Primary completion1 Jul 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patients With Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suleyman Korkusuz, Hacettepe University
- Investigators
- Süleyman Korkusuz, PhD, Principal investigator, Atılım UniversityBüşra Seçkinoğulları Korkusuz, MSc, Study chair, Ankara UniversityAyşenur Özcan, Study chair, Çankırı Karatekin UniversityEmine Nur Demircan, Msc, Study chair, Hacettepe UniversityFerdi Yavuz, Assoc.Prof, Study chair, European University of LefkeBülent Elibol, Prof.Dr., Study chair, Hacettepe UniversityGül Yalçın Çakmaklı, Assoc.Prof, Study chair, Hacettepe UniversityAyla Fil Balkan, Assoc.Prof, Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505343
- Sponsor's protocol ID
- e2d1895a2fd54888
- Status last verified
- Aug 2024
- First submitted
- 6 May 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morris ME, Iansek R, Matyas TA, Summers JJ. The pathogenesis of gait hypokinesia in Parkinson's disease. Brain. 1994 Oct;117 ( Pt 5):1169-81. doi: 10.1093/brain/117.5.1169.
PubMed 7953597Giladi N, Nieuwboer A. Understanding and treating freezing of gait in parkinsonism, proposed working definition, and setting the stage. Mov Disord. 2008;23 Suppl 2:S423-5. doi: 10.1002/mds.21927. No abstract available.
PubMed 18668629
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Freezing Phenomenon on Gait Parameters and Pedobarographic Pressure Distribution in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06505343
- Acronym / sponsor ID
- e2d1895a2fd54888
- Conditions
- Patients With Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parkinson's patients with freezing phenomenon | – | –Parkinson's patients with freezing phenomenon |
| Parkinson's patients without freezing phenomenon | – | –Parkinson's patients without freezing phenomenon |
| Healthy | – | –Healthy |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's disease
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Computerized Gait Evaluation System
Time frame: Baseline
This system allows the measurement of spatiotemporal features of gait.
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
Kinematic analysis
Time frame: Baseline
Kinematic analysis of the gait can be performed with the camera support within the system.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Background: PubMed 7953597Morris ME, Iansek R, Matyas TA, Summers JJ. The pathogenesis of gait hypokinesia in Parkinson's disease. Brain. 1994 Oct;117 ( Pt 5):1169-81. doi: 10.1093/brain/117.5.1169.
- Background: PubMed 18668629Giladi N, Nieuwboer A. Understanding and treating freezing of gait in parkinsonism, proposed working definition, and setting the stage. Mov Disord. 2008;23 Suppl 2:S423-5. doi: 10.1002/mds.21927. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Süleyman Korkusuz, PhD principal investigator
Atılım University
Büşra Seçkinoğulları Korkusuz, MSc study chair
Ankara University
Ayşenur Özcan study chair
Çankırı Karatekin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Parkinson's Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Computerized Gait Evaluation System (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06505343, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.