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NCT Number: NCT06840223

Thoracolumbar Fascia Release on Pulmonary Function in Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Fascial Manipulation Nervous System Diseases Pulmonary Function Vascular Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli Sağlık ve Teknoloji Üniversitesi

Kocaeli, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Traditional stroke rehabilitation

Other

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 release

Other

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 exercise

Other

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Kocaeli Sağlık ve Teknoloji Üniversitesi

Other

Collaborators

  • İnönü Üniversitesi

Registry information

Official study title

Immediate Effects of Thoracolumbar Fascia Release on Pulmonary Function in Stroke Patients: a Randomized Controlled Study

Acronym: TLF-STROKE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 21, 2025
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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