Clinical trial NCT06840223: Thoracolumbar Fascia Release on Pulmonary Function in Stroke
Official title: Immediate Effects of Thoracolumbar Fascia Release on Pulmonary Function in Stroke Patients: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Pulmonary Function
Fascial Manipulation
Keywords: myofascial release
pulmonary function test
spirometry
stroke
thoracolumbar fascia
Lead sponsor: Kocaeli Sağlık ve Teknoloji Üniversitesi
Sponsor class: OTHER
Collaborators: name: İnönü Üniversitesi
First posted: 2025-02-21
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pulmonary Function
timeFrame: From enrollment to the immediately after one session of treatment in all groups
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli Sağlık ve Teknoloji Üniversitesi
Study officials:
References: