NCT07006376

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 5, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

June 11, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2025

Completed
Last Updated

March 25, 2026

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

May 28, 2025

Last Update Submit

March 22, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    Baseline

  • Range of Motion Assessment

    Active trunk ranges of motion will be assessed during flexion/extension, rotation, and lateral flexion using a universal goniometer.

    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.

    Baseline

Study Arms (2)

Study Group

Patients with Parkinson's Disease

Control Group

Healthy individuals with similar demographic characteristics

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Parkinson's Disease

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atılım University

Ankara, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

  • Yerli 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.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Ayla Fil Balkan, Assoc Prof

    Hacettepe University

    STUDY CHAIR
  • Gül Yalçın Çakmaklı, Assoc Prof

    Hacettepe University

    STUDY CHAIR
  • Süleyman Korkusuz, Assist.Prof

    Atılım University

    STUDY CHAIR
  • Büşra Seçkinoğulları Korkusuz, PhD

    Ankara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 28, 2025

First Posted

June 5, 2025

Study Start

June 11, 2025

Primary Completion

August 20, 2025

Study Completion

September 20, 2025

Last Updated

March 25, 2026

Record last verified: 2025-07

Locations