NCT07107295

Brief Summary

The main objective of this study was to examine the thoracolumbar fascia thickness in chronic stroke patients using objective methods and to reveal the relationship of this flexibility with balance, trunk control, trunk flexibility, functional independence and other relevant clinical parameters. Demographic information will be recorded and evaluated. Thoracolumbar fascia thickness will be assessed for individuals in both groups using ultrasonography, trunk flexibility using the Sit-and-Reach test, trunk function using the Trunk Impairment Scale, balance using the Functional Reach Test and the Timed Up and Go test, and functional independence using the Functional Independence Scale.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 24, 2026

Status Verified

July 1, 2025

Enrollment Period

8 months

First QC Date

July 30, 2025

Last Update Submit

March 22, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • Ultrasonographic Assessment

    In this study, ultrasonography will be used to assess the thickness of the thoracolumbar fascia in participants. Participants will be assessed in a comfortable prone position. A physical therapist trained in musculoskeletal ultrasonography will measure the thickness of the thoracolumbar fascia at standard anatomical landmarks. During measurements, care will be taken to ensure the probe is placed perpendicularly and steadily against the muscle tissue, and the images will be optimized and recorded to ensure accurate measurement of muscle thickness. Data obtained will be expressed in millimeters and recorded along with the participants' age, gender, and other demographic information.

    Baseline

  • Sit-and-Reach Test

    This study will be used to assess the flexibility of participants' hamstrings and lumbar extensors. This test is a standardized assessment method that measures how far a person can reach in a seated position with their legs straight, typically using a flexibility box or tape measure. Participants will be asked to sit with their legs straight and lean forward, with their feet resting on the measuring box or wall, without bending their knees. They will be asked to touch their toes as far forward as possible. The farthest point they reach will be recorded in centimeters. The test will be repeated twice, and the best performance will be considered. The resulting values will be used in analyses as an indicator of participants' trunk and lower extremity flexibility levels.

    Baseline

  • Functional Reach Test

    This test is a simple and reliable method for measuring static balance, measuring the maximum distance in centimeters a person can extend their arm forward while standing. The participant is asked to stand parallel to a wall, make a fist with their arm flexed 90 degrees at shoulder height, and reach forward as far as possible without losing their balance or lifting their feet off the ground. The distance between the initial toe position and the maximum reach position is recorded. The test will be repeated three times, and the best performances will be evaluated.

    Baseline

  • Timed up Go Test

    The test assesses functional mobility and balance. The participant rises from a chair, walks 3 meters, turns, walks back to the chair, and sits down. The duration of this activity is recorded with a stopwatch. The test can be performed with the individual's usual assistive devices to ensure safety. Multiple attempts are usually required to ensure optimal performance.

    Baseline

  • Trunk Impairment Scale

    This scale consists of three main sections: static sitting balance, dynamic sitting balance, and trunk coordination. The TIS, which contains 17 items in total, has a maximum score of 23, with higher scores indicating greater trunk control and mobility. The assessment will be conducted by a qualified physiotherapist in accordance with established standard procedures. The results obtained from the scale will be used in statistical analyses as an objective indicator of participants' trunk performance and will be an important data source for determining relationships with other functional parameters.

    Baseline

  • Functional Independence Measure

    The test will be used to assess participants' levels of independence in activities of daily living and their care needs.Each item is scored from 1 (complete dependence) to 7 (complete independence), and the total score ranges from 18 to 126. Higher FIM scores indicate greater functional independence.

    Baseline

Study Arms (2)

Study Group

Chronic Stroke Patients

Control Group

Healthy individuals with similar demographic characteristics

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic stroke patients between the ages of 40 and 70 who are receiving routine treatment at a Private University Hospital and healthy individuals with similar demographic characteristics will be included in the study.

You may qualify if:

  • Being between 40 and 70 years old.
  • Being diagnosed with a stroke by a neurologist.
  • Scoring above 21 on the Montreal Cognitive Assessment Scale.
  • Scoring between 0 and 3 on the Modified Rankin Scale.
  • Being at least 6 months past the stroke

You may not qualify if:

  • Inability to communicate verbally
  • Individuals with severe visual impairment, neurological disorders in addition to stroke, and/or congestive heart failure
  • Patients in whom exercise is not recommended.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Verheyden G, Nieuwboer A, Mertin J, Preger R, Kiekens C, De Weerdt W. The Trunk Impairment Scale: a new tool to measure motor impairment of the trunk after stroke. Clin Rehabil. 2004 May;18(3):326-34. doi: 10.1191/0269215504cr733oa.

  • 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

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Süleyman Korkusuz, PhD

    Atılım University

    STUDY CHAIR
  • Büşra Seçkinoğulları Korkusuz, PhD

    Ankara University

    PRINCIPAL INVESTIGATOR
  • Ayşenur Özcan, MSc

    Çankırı Karatekin University

    STUDY CHAIR
  • Ali Mert Özcan, MSc

    Baskent University

    STUDY CHAIR

Central Study Contacts

Büşra Seçkinoğulları Korkusuz, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

July 30, 2025

First Posted

August 6, 2025

Study Start

August 1, 2025

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

March 24, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations