Thoracolumbar Fascia Release on Pulmonary Function in Stroke

NCT ID: NCT06840223

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-12-01

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.

Conditions

Stroke; Pulmonary Function; Fascial Manipulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Traditional stroke rehabilitation

Traditional personalized stroke rehabilitation

Group Type: EXPERIMENTAL

Traditional stroke rehabilitation

Intervention Type: 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

Traditional personalized stroke rehabilitation plus thorakolumbar fascia release

Group Type: EXPERIMENTAL

Thoracolumbar fascia release

Intervention Type: 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

Traditional personalized stroke rehabilitation plus respiratory exercise

Group Type: EXPERIMENTAL

Respiratory exercise

Intervention Type: 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.

Interventions

Traditional stroke rehabilitation

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

Intervention Type: OTHER

Thoracolumbar fascia release

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.

Intervention Type: OTHER

Respiratory exercise

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

İnönü Üniversitesi

UNKNOWN

Sponsor Role: collaborator

Kocaeli Sağlık ve Teknoloji Üniversitesi

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kocaeli Sağlık ve Teknoloji Üniversitesi

Kocaeli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KOSTU-25-STROKE-01

Identifier Type: -

Identifier Source: org_study_id