Parkinson DiseaseNCT07006376
Thoracolumbar Fascia Thickness in Patients With Parkinson's Disease
An observational study of Parkinson Disease, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine thoracolumbar fascia thickness, trunk flexibility, trunk control and upper extremity skills in Parkinson's disease patients. Patients between the ages of 55-80 who have been diagnosed with Parkinson's disease by a neurologist and healthy individuals with similar demographic… Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jun 2025to 20 Sep 2025
- 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 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Parkinson's Disease
Who may be able to join
- Age between 50 and 80
- Mini Mental State Examination (MMSE) score between 24 and 30
- Diagnosed with Parkinson's by a neurologist
- MH\&Y stage 2-3
Who cannot join
- Inability to communicate verbally
- Use of walking aids
- Elderly people with severe visual impairment, neurological disorders and/or congestive heart failure
- Older adults in whom exercise is not recommended.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Thoracolumbar Fascia Thickness, Trunk Flexibility and Manual Dexterity in Parkinson's Disease Patients
The aim of this study is to examine thoracolumbar fascia thickness, trunk flexibility, trunk control and upper extremity skills in Parkinson's disease patients. Patients between the ages of 55-80 who have been diagnosed with Parkinson's disease by a neurologist and healthy individuals with similar demographic characteristics will be included in the study as a control group. Demographic information of the individuals will be recorded and clinical evaluations will be made. Staging of Parkinson's patients will be done with the Modified Hoehn and Yahr Scale (MHRS), and disease severity will be done with the Unified Parkinson's Disease Rating Scale (UPDRS). Thoracolumbar fascia thickness of individuals in both groups will be evaluated with ultrasonography, trunk flexibility with the Active Trunk Range of Motion Assessment and Sit-Reach test, trunk functions with the Trunk Impairment Scale, and manual skills with the Purdue Pegboard Test.
- Conditions
- Parkinson Disease
- 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 |
|---|---|---|
| Study Group | Patients with Parkinson's Disease | |
| Control Group | Healthy individuals with similar demographic characteristics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonography Measurement
The thickness of the Thoracolumbar Fascia will be measured by ultrasonography at the level of the L3 lumbar vertebra and using a predefined standard protocol.
Measured: Baseline
Range of Motion Assessment
Active trunk ranges of motion will be assessed during flexion/extension, rotation, and lateral flexion using a universal goniometer.
Measured: Baseline
Sit and Reach Test
For this test, a tape measure will be fixed to a table at the exact level of the subjects' feet. Subjects will sit in front of the table with bare feet and legs straight. Then, they will slowly extend forward as far as possible, keeping their hands together and without bending their knees. During this extension, attention will be paid to the subjects' straight backs and to avoid sudden movements.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start11 Jun 2025
- Primary completion20 Aug 2025
- Study completion20 Sep 2025
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 Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Ankara 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Seçkinoğulları Korkusuz, Ankara University
- Investigators
- Ayla Fil Balkan, Assoc Prof, Study chair, Hacettepe UniversityGül Yalçın Çakmaklı, Assoc Prof, Study chair, Hacettepe UniversitySüleyman Korkusuz, Assist.Prof, Study chair, Atılım UniversityBüşra Seçkinoğulları Korkusuz, PhD, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006376
- Sponsor's protocol ID
- E-59394181-604.01-112208
- Status last verified
- Jul 2025
- First submitted
- 28 May 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
De Coninck K, Hambly K, Dickinson JW, Passfield L. Measuring the morphological characteristics of thoracolumbar fascia in ultrasound images: an inter-rater reliability study. BMC Musculoskelet Disord. 2018 Jun 1;19(1):180. doi: 10.1186/s12891-018-2088-5.
PubMed 29859080Yerli S, Yinanc SB, Yagci G, Erbahceci F, Ozcakar L. Thoracolumbar fascia and chronic low back pain in idiopathic lumbar scoliosis: an ultrasonographic study. Eur Spine J. 2024 Jun;33(6):2469-2475. doi: 10.1007/s00586-024-08266-x. Epub 2024 Apr 23.
PubMed 38653872
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Thoracolumbar Fascia Thickness, Trunk Flexibility and Manual Dexterity in Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT07006376
- Acronym / sponsor ID
- E-59394181-604.01-112208
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 20 Sep 2025 (actual)
- First posted
- 5 Jun 2025 (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.
The aim of this study is to examine thoracolumbar fascia thickness, trunk flexibility, trunk control and upper extremity skills in Parkinson's disease patients. Patients between the ages of 55-80 who have been diagnosed with Parkinson's disease by a neurologist and healthy individuals with similar demographic characteristics will be included in the study as a control group. Demographic information of the individuals will be recorded and clinical evaluations will be made. Staging of Parkinson's patients will be done with the Modified Hoehn and Yahr Scale (MHRS), and disease severity will be done with the Unified Parkinson's Disease Rating Scale (UPDRS). Thoracolumbar fascia thickness of individuals in both groups will be evaluated with ultrasonography, trunk flexibility with the Active Trunk Range of Motion Assessment and Sit-Reach test, trunk functions with the Trunk Impairment Scale, and manual skills with the Purdue Pegboard Test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | –Patients with Parkinson's Disease |
| Control Group | – | –Healthy individuals with similar demographic characteristics |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's Disease
Key inclusion criteria (4 listed)
- Age between 50 and 80
- Mini Mental State Examination (MMSE) score between 24 and 30
- Diagnosed with Parkinson's by a neurologist
- MH\&Y stage 2-3
Key exclusion criteria (4 listed)
- Inability to communicate verbally
- Use of walking aids
- Elderly people with severe visual impairment, neurological disorders and/or congestive heart failure
- Older adults in whom exercise is not recommended.
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
Ultrasonography Measurement
Time frame: Baseline
The thickness of the Thoracolumbar Fascia will be measured by ultrasonography at the level of the L3 lumbar vertebra and using a predefined standard protocol.
Range of Motion Assessment
Time frame: Baseline
Active trunk ranges of motion will be assessed during flexion/extension, rotation, and lateral flexion using a universal goniometer.
Sit and Reach Test
Time frame: Baseline
For this test, a tape measure will be fixed to a table at the exact level of the subjects' feet. Subjects will sit in front of the table with bare feet and legs straight. Then, they will slowly extend forward as far as possible, keeping their hands together and without bending their knees. During this extension, attention will be paid to the subjects' straight backs and to avoid sudden movements.
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 25 Mar 2026.
- Results publication: PubMed 29859080De Coninck K, Hambly K, Dickinson JW, Passfield L. Measuring the morphological characteristics of thoracolumbar fascia in ultrasound images: an inter-rater reliability study. BMC Musculoskelet Disord. 2018 Jun 1;19(1):180. doi: 10.1186/s12891-018-2088-5.
- Results publication: PubMed 38653872Yerli S, Yinanc SB, Yagci G, Erbahceci F, Ozcakar L. Thoracolumbar fascia and chronic low back pain in idiopathic lumbar scoliosis: an ultrasonographic study. Eur Spine J. 2024 Jun;33(6):2469-2475. doi: 10.1007/s00586-024-08266-x. Epub 2024 Apr 23.
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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.
Ayla Fil Balkan, Assoc Prof study chair
Hacettepe University
Gül Yalçın Çakmaklı, Assoc Prof study chair
Hacettepe University
Süleyman Korkusuz, Assist.Prof study chair
Atılım 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 Parkinson Disease, run by Ankara 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 4 inclusion and 4 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 25 Mar 2026. 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?
Ultrasonography Measurement (time frame: Baseline). The study lists 3 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 NCT07006376, 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 25 Mar 2026.