StrokeTLF-STROKENCT06840223
Thoracolumbar Fascia Release on Pulmonary Function in Stroke
A study testing Traditional stroke rehabilitation, Thoracolumbar fascia release and Respiratory exercise in people with Stroke and Pulmonary Function, run by Kocaeli Sağlık ve Teknoloji Üniversitesi at 1 site in Turkey (Türkiye).
Trial summary
This study looks at how thoracolumbar fascia release affects breathing in people who had a stroke. After a stroke, many people have trouble breathing well because their muscles become stiff. We want to see if releasing the thoracolumbar fascia (a big sheet of tissue in the lower back) can help improve lung function. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Stroke, Pulmonary Function, Fascial Manipulation
- What is being tested?
- Traditional stroke rehabilitation, Thoracolumbar fascia release and Respiratory exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 1 Dec 2024
- Phase
- Interventional
- 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 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants were male patients aged 18-65 years, diagnosed with monohemispheric ischemic stroke above the brainstem, confirmed through computed tomography or magnetic resonance imaging and a stroke diagnosis at least six months prior to the study.
Who cannot join
- Severe cardiorespiratory or neuromuscular disease, tracheostomy, obesity (BMI ≥30 kg/m²), rib cage deformity, cognitive impairment (Mini-Mental State Examination score ≤ 20), and severe dysphagia, aphasia or confusion.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli Sağlık ve Teknoloji Üniversitesi
Kocaeli
About this study
Official title: Immediate Effects of Thoracolumbar Fascia Release on Pulmonary Function in Stroke Patients: a Randomized Controlled Study
This study looks at how thoracolumbar fascia release affects breathing in people who had a stroke. After a stroke, many people have trouble breathing well because their muscles become stiff. We want to see if releasing the thoracolumbar fascia (a big sheet of tissue in the lower back) can help improve lung function.
Participants will be divided into three groups:
Read more
Control group - Receives standard stroke rehabilitation. Breathing exercise group - Gets standard rehabilitation plus breathing exercises.
Thoracolumbar fascia release group - Gets standard rehabilitation plus thoracolumbar fascia release therapy.
We will measure lung function right after a single session to see if this therapy makes breathing easier.
Our primary outcome is to check if thoracolumbar fascia release improves lung function compared to the other groups.
This study hopes to find new ways to help stroke survivors breathe better and feel more comfortable.
Read the detailed description
This randomized controlled study investigates the immediate effects of thoracolumbar fascia (TLF) release on pulmonary function in stroke patients. Post-stroke impairments often lead to respiratory dysfunction due to musculoskeletal restrictions and altered neuromuscular control. Given the biomechanical connections between the thoracolumbar fascia and the respiratory system, we hypothesize that TLF release may enhance pulmonary mechanics by improving respiratory functions, in single session.
Participants randomly assigned into three groups:
Control group - Receives standard post-stroke rehabilitation. Respiratory exercise group - Undergoes standard rehabilitation combined with structured breathing exercises.
TLF release group - Receives standard rehabilitation along with thoracolumbar fascia release.
The primary outcome measure is the immediate change in spirometric parameters, including forced vital capacity (FVC%), forced expiratory volume in one second (FEV₁%), FEV₁/FVC (tiffeneu index) and peak expiratory flow (PEF%).
By evaluating the acute effects of thoracolumbar fascial release on respiratory function, this study aims to explore a potential adjunct therapy for post-stroke pulmonary rehabilitation.
- Conditions
- Stroke, Pulmonary Function, Fascial Manipulation
- Being tested
- Traditional stroke rehabilitation, Thoracolumbar fascia release, Respiratory exercise
- Keywords
- myofascial release, pulmonary function test, spirometry, stroke, thoracolumbar fascia
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional stroke rehabilitationOther
Personalized traditional stroke rehabilitation programme including spasticity inhibition, sensory-perceptual-motor integration techniques, core stabilization and strengthening exercises, balance training i.e. applied as needed for stroke patients approximately for 45 minutes
Thoracolumbar fascia releaseOther
Thoracolumbar fascia release was performed by physiotherapist for one session. Supine Pelvic Rotation, Supine Arm Elevation, Bending Forward in Sitting Position and Sitting Crossed Arm and Knee Positions were performed approximately for 10-15 minutes after 45 minutes of traditional stroke rehabilitation.
Respiratory exerciseOther
Respiratory exercises were performed by physiotherapist for one session. Pursed-Lip Breathing, Deep Breathing Exercise, Diaphragm Strengthening Exercise and Thoracic Expansion Exercises were performed approximately for 10-15 minutes after 45 minutes of traditional stroke rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Traditional stroke rehabilitation | Experimental | Traditional personalized stroke rehabilitation Receives: Other: Traditional stroke rehabilitation |
| Thoracolumbar fascia release | Experimental | Traditional personalized stroke rehabilitation plus thorakolumbar fascia release Receives: Other: Thoracolumbar fascia release |
| Respiratory exercise | Experimental | Traditional personalized stroke rehabilitation plus respiratory exercise Receives: Other: Respiratory exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Function
Spirometric measurements were performed by respiratory physical therapist using COSMED Pony FX spirometer (Elsa Medical Ltd., Rome, Italy) portable device. FEV1(%), FVC (%) and FEV1/FVC and PEF (%) were taken to assess the pulmonary functions.
Measured: From enrollment to the immediately after one session of treatment in all groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Nov 2022
- Primary completion1 Jun 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli Sağlık ve Teknoloji Üniversitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Inonu University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840223
- Sponsor's protocol ID
- KOSTU-25-STROKE-01
- Acronym
- TLF-STROKE
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared after ensuring the protection of participants' personal data
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Thoracolumbar Fascia Release on Pulmonary Function in Stroke Patients: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06840223
- Acronym / sponsor ID
- TLF-STROKE / KOSTU-25-STROKE-01
- Conditions
- Stroke, Pulmonary Function, Fascial Manipulation
- Keywords
- myofascial release, pulmonary function test, spirometry, stroke, thoracolumbar fascia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Kocaeli Sağlık ve Teknoloji ÜniversitesiUniversity, hospital or other
- Collaborators
- Inonu University
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 21 Feb 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.
This study looks at how thoracolumbar fascia release affects breathing in people who had a stroke. After a stroke, many people have trouble breathing well because their muscles become stiff. We want to see if releasing the thoracolumbar fascia (a big sheet of tissue in the lower back) can help improve lung function.
Participants will be divided into three groups:
Control group - Receives standard stroke rehabilitation. Breathing exercise group - Gets standard rehabilitation plus breathing exercises.
Thoracolumbar fascia release group - Gets standard rehabilitation plus thoracolumbar fascia release therapy.
We will measure lung function right after a single session to see if this therapy makes breathing easier.
Our primary outcome is to check if thoracolumbar fascia release improves lung function compared to the other groups.
This study hopes to find new ways to help stroke survivors breathe better and feel more comfortable.
Detailed description
This randomized controlled study investigates the immediate effects of thoracolumbar fascia (TLF) release on pulmonary function in stroke patients. Post-stroke impairments often lead to respiratory dysfunction due to musculoskeletal restrictions and altered neuromuscular control. Given the biomechanical connections between the thoracolumbar fascia and the respiratory system, we hypothesize that TLF release may enhance pulmonary mechanics by improving respiratory functions, in single session.
Participants randomly assigned into three groups:
Control group - Receives standard post-stroke rehabilitation. Respiratory exercise group - Undergoes standard rehabilitation combined with structured breathing exercises.
TLF release group - Receives standard rehabilitation along with thoracolumbar fascia release.
The primary outcome measure is the immediate change in spirometric parameters, including forced vital capacity (FVC%), forced expiratory volume in one second (FEV₁%), FEV₁/FVC (tiffeneu index) and peak expiratory flow (PEF%).
By evaluating the acute effects of thoracolumbar fascial release on respiratory function, this study aims to explore a potential adjunct therapy for post-stroke pulmonary rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditional stroke rehabilitation | Experimental | Other: Traditional stroke rehabilitationTraditional personalized stroke rehabilitation |
| Thoracolumbar fascia release | Experimental | Other: Thoracolumbar fascia releaseTraditional personalized stroke rehabilitation plus thorakolumbar fascia release |
| Respiratory exercise | Experimental | Other: Respiratory exerciseTraditional personalized stroke rehabilitation plus respiratory exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible participants were male patients aged 18-65 years, diagnosed with monohemispheric ischemic stroke above the brainstem, confirmed through computed tomography or magnetic resonance imaging and a stroke diagnosis at least six months prior to the study.
Key exclusion criteria (1 listed)
- Severe cardiorespiratory or neuromuscular disease, tracheostomy, obesity (BMI ≥30 kg/m²), rib cage deformity, cognitive impairment (Mini-Mental State Examination score ≤ 20), and severe dysphagia, aphasia or confusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional stroke rehabilitationPersonalized traditional stroke rehabilitation programme including spasticity inhibition, sensory-perceptual-motor integration techniques, core stabilization and strengthening exercises, balance training i.e. applied as needed for stroke patients approximately for 45 minutes | Other | Traditional stroke rehabilitation |
| Thoracolumbar fascia releaseThoracolumbar fascia release was performed by physiotherapist for one session. Supine Pelvic Rotation, Supine Arm Elevation, Bending Forward in Sitting Position and Sitting Crossed Arm and Knee Positions were performed approximately for 10-15 minutes after 45 minutes of traditional stroke rehabilitation. | Other | Thoracolumbar fascia release |
| Respiratory exerciseRespiratory exercises were performed by physiotherapist for one session. Pursed-Lip Breathing, Deep Breathing Exercise, Diaphragm Strengthening Exercise and Thoracic Expansion Exercises were performed approximately for 10-15 minutes after 45 minutes of traditional stroke rehabilitation. | Other | Respiratory exercise |
Primary outcome
Pulmonary Function
Time frame: From enrollment to the immediately after one session of treatment in all groups
Spirometric measurements were performed by respiratory physical therapist using COSMED Pony FX spirometer (Elsa Medical Ltd., Rome, Italy) portable device. FEV1(%), FVC (%) and FEV1/FVC and PEF (%) were taken to assess the pulmonary functions.
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 21 Feb 2025.
- Individual participant dataSharing planned: Undecided. IPD will be shared after ensuring the protection of participants' personal data
Related trials for Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional stroke rehabilitation, Thoracolumbar fascia release and Respiratory exercise in people with Stroke and Pulmonary Function, run by Kocaeli Sağlık ve Teknoloji Üniversitesi 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 1 inclusion and 1 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 21 Feb 2025. 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?
Pulmonary Function (time frame: From enrollment to the immediately after one session of treatment in all groups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2025.