Thoracolumbar Fascia Release on Pulmonary Function in Stroke

NCT06840223 | Completed

• 1 other identifier: KOSTU-25-STROKE-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Pulmonary Function; Fascial Manipulation

Keywords

myofascial release; pulmonary function test; spirometry; stroke; thoracolumbar fascia

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the immediately after one session of treatment in all groups

Study Arms (3)

Traditional stroke rehabilitation

EXPERIMENTAL

Traditional personalized stroke rehabilitation

Other: Traditional stroke rehabilitation

Thoracolumbar fascia release

EXPERIMENTAL

Traditional personalized stroke rehabilitation plus thorakolumbar fascia release

Other: Thoracolumbar fascia release

Respiratory exercise

EXPERIMENTAL

Traditional personalized stroke rehabilitation plus respiratory exercise

Other: Respiratory exercise

Interventions

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

Traditional stroke rehabilitation

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.

Thoracolumbar fascia release

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.

Respiratory exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kocaeli Sağlık ve Teknoloji Üniversitesi: lead
• İnönü Üniversitesi: collaborator

Study Sites (1)

Kocaeli Sağlık ve Teknoloji Üniversitesi

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: November 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 21, 2025

Record last verified: 2025-02

Locations

TU (1)