Idiopathic Parkinson's DiseaseNCT05107531
Investigation of Gait, Foot Pressure Distribution and Balance in Parkinson's Patients With Motor Freezing
An observational study of Idiopathic Parkinson's Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Parkinson's Disease
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2021to 5 Feb 2022
- 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: Parkinson's patients and healthy individuals who applied to Hacettepe University Neurology Clinic as voluntary participants will be included in this study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Keywords
- Postural Balance, Parkinson's Disease, Gait Analysis, Kinematic Analysis, Motor Freezing, Spatio-Temporal Analysis, Foot Pressure Distribution
- Medical subject headings
- Parkinson 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 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (2)
Unified Parkinson's Disease Rating Scale
It is used to evaluate the symptoms of the disease and the complications that develop due to treatment. In this scale, which consists of 4 parts, the scoring of each item is between 0-4 points. The increase in the total score reflects the increase in the severity of the symptoms.
Measured: Baseline
Freezing of Gait Questionnaire
The scale is a scale that evaluates motor freezing in Parkinson's patients. It is questioned whether freezing occurs during activities such as walking and turning on the 6-item scale developed. In addition, in the presence of freezing, the severity, frequency and duration of freezing are recorded.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start10 Sep 2021
- Primary completion5 Feb 2022
- Study completion5 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Idiopathic 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suleyman Korkusuz, Hacettepe University
- Investigators
- Kadriye Armutlu, Prof. Dr., Study chair, Hacettepe UniversitySüleyman Korkusuz, MSc, Principal investigator, Hacettepe UniversityEmine Nur Demircan, MSc, Study chair, Hacettepe UniversityAyşenur Özcan, MSc, Study chair, Hacettepe UniversityBüşra Seçkinoğulları, MSc, Study chair, Hacettepe UniversityGül Yalçın Çakmaklı, Assoc. Prof., Study chair, Hacettepe UniversityBülent Elibol, Prof. Dr., Study chair, Hacettepe UniversityFerdi Yavuz, Assoc. Prof., Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107531
- Sponsor's protocol ID
- GO21/777
- Status last verified
- Feb 2022
- First submitted
- 18 Oct 2021
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26762797Mezzarobba 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.
PubMed 29413805Bekkers 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.
PubMed 30125601Shah 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.
PubMed 29773512Chee 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.
PubMed 19433440Yang 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.
PubMed 17890091
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Gait, Foot Pressure Distribution and Balance in Parkinson's Patients With Motor Freezing
- ClinicalTrials.gov ID
- NCT05107531
- Acronym / sponsor ID
- GO21/777
- Conditions
- Idiopathic Parkinson's Disease
- Keywords
- Postural Balance, Parkinson's Disease, Gait Analysis, Kinematic Analysis, Motor Freezing, Spatio-Temporal Analysis, Foot Pressure Distribution
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 5 Feb 2022 (actual)
- Study completion
- 5 Feb 2022 (actual)
- First posted
- 4 Nov 2021 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's patients and healthy individuals who applied to Hacettepe University Neurology Clinic as voluntary participants will be included in this study.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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
E-LINK FP3 Force Plate
Time frame: Baseline
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.
KoreBalance Balance Evaluation System
Time frame: Baseline
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.
Functional Reach Test
Time frame: Baseline
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.
Time Up and Go Test
Time frame: Baseline
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.
Computerized Gait Assessment System (Zebris Rehawalk)
Time frame: Baseline
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.
2 secondary outcomes
Unified Parkinson's Disease Rating Scale
Time frame: Baseline
Freezing of Gait Questionnaire
Time frame: Baseline
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 22 Feb 2022.
- Background: PubMed 26762797Schlenstedt 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.
- Background: PubMed 29413805Mezzarobba 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.
- Background: PubMed 30125601Bekkers 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.
- Background: PubMed 29773512Shah 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.
- Background: PubMed 19433440Chee 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.
- Background: PubMed 17890091Yang 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.
- 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.
Kadriye Armutlu, Prof. Dr. study chair
Hacettepe University
Süleyman Korkusuz, MSc principal investigator
Hacettepe University
Emine Nur Demircan, MSc study chair
Hacettepe 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 Idiopathic 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 6 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 22 Feb 2022. 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?
E-LINK FP3 Force Plate (time frame: Baseline). The study lists 5 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 NCT05107531, which also lists 6 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 22 Feb 2022.