Effect of Diaphragmatic Breathing Training on Trunk Control and Postural Stability in Individuals With Chronic Stroke
9. September 2026 aktualisiert von: fatma shehata
Effect of Diaphragmatic Breathing Training on Trunk Control and Postural Stability in Individuals With Chronic Stroke: A Randomized Controlled Trial
This randomized controlled trial will investigate whether adding diaphragmatic breathing training to conventional physiotherapy improves trunk control and postural stability in individuals with chronic stroke compared with conventional physiotherapy alone.
Forty participants with chronic unilateral stroke will be randomly allocated in a 1:1 ratio to either an experimental group receiving diaphragmatic breathing training plus conventional physiotherapy or a control group receiving conventional physiotherapy alone.
The intervention will be provided three times per week for six weeks.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The study will use a prospective, two-arm, parallel-group randomized controlled design. Forty individuals with chronic unilateral stroke will be recruited and randomly allocated to either an experimental group or a control group in a 1:1 ratio.
The experimental group will receive standard diaphragmatic breathing training in addition to conventional physiotherapy. The control group will receive the same conventional physiotherapy program without diaphragmatic breathing training.
Both groups will receive three treatment sessions per week for six weeks, for a total of 18 sessions.
Trunk control and postural stability will be assessed at baseline and after completion of the six-week intervention. Trunk control will be assessed using the Trunk Impairment Scale, while postural stability will be assessed using the Biodex Balance System. Functional mobility will be assessed using the Timed Up and Go test.
Primary C
Studientyp
Interventionell
Einschreibung (Geschätzt)
40
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: fatma shehata mohamad, phD
- Telefonnummer: +201014001578
- E-Mail: Fatma.mohamad@the.suezuni.edu.eg
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
Inclusion Criteria:Adults aged 40-65 years.
- Clinically diagnosed unilateral stroke.
- Chronic stroke stage of at least 6 months.
- Able to sit independently without physical assistance.
- Able to walk 10 meters with or without an assistive device.
- Mini-Mental State Examination (MMSE) score ≥24.
- Modified Ashworth Scale (MAS) score ≤2 in the affected upper and lower limb muscles.
- Medically stable.
- Able to understand and follow simple instructions.
- Willing to participate and provide written informed consent. Exclusion Criteria:Other neurological disorders.
- Bilateral neurological deficits or multiple deficits substantially interfering with trunk control, balance, or gait.
- Severe cardiopulmonary disease limiting participation in exercise.
- Severe musculoskeletal disorders affecting the trunk or lower limbs.
- Severe cognitive impairment.
- Severe aphasia preventing understanding of instructions.
- Significant visual or vestibular impairment affecting balance assessment.
- Uncontrolled medical conditions.
- Current participation in another structured rehabilitation program.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Diaphragmatic Breathing Training and Conventional Physiotherapy
Participants will receive conventional physiotherapy combined with standard diaphragmatic breathing training.
Diaphragmatic breathing training will involve slow nasal inspiration emphasizing abdominal/lower rib cage expansion, followed by slow controlled oral expiration while minimizing upper chest and shoulder movement.
Training will be provided for approximately 10-15 minutes per session, three sessions per week for six weeks.
|
Standard diaphragmatic breathing training involving slow nasal inspiration with abdominal and lower rib cage expansion, minimal upper chest movement, and slow controlled oral expiration.
Participants will perform approximately 10 breaths per set for three sets, with rest periods as needed.
Training will be provided for approximately 10-15 minutes per session, three times per week for six weeks.A standardized conventional physiotherapy program including postural alignment and trunk activation, sitting weight-shifting, controlled trunk rotation, sit-to-stand training, standing weight-shifting, static standing balance, and functional mobility/gait training.
Treatment will be provided three times per week for six weeks.
|
|
Aktiver Komparator: Conventional Physiotherapy
Participants will receive the same standardized conventional physiotherapy program as the experimental group without diaphragmatic breathing training.
Treatment will be provided three sessions per week for six weeks.
|
Standard diaphragmatic breathing training involving slow nasal inspiration with abdominal and lower rib cage expansion, minimal upper chest movement, and slow controlled oral expiration.
Participants will perform approximately 10 breaths per set for three sets, with rest periods as needed.
Training will be provided for approximately 10-15 minutes per session, three times per week for six weeks.A standardized conventional physiotherapy program including postural alignment and trunk activation, sitting weight-shifting, controlled trunk rotation, sit-to-stand training, standing weight-shifting, static standing balance, and functional mobility/gait training.
Treatment will be provided three times per week for six weeks.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Trunk Impairment Scale
Zeitfenster: Baseline (Week 0) and post-intervention (Week 6)
|
Trunk control will be assessed using the original 17-item Trunk Impairment Scale, which evaluates static sitting balance, dynamic sitting balance, and coordination.
Total scores range from 0 to 23, with higher scores indicating better trunk control.
|
Baseline (Week 0) and post-intervention (Week 6)
|
|
Trunk Impairment Scale (TIS)
Zeitfenster: Baseline (Week 0) and post-intervention (Week 6)
|
Trunk control will be assessed using the original 17-item Trunk Impairment Scale, which evaluates static sitting balance, dynamic sitting balance, and coordination.
Total scores range from 0 to 23, with higher scores indicating better trunk control.
|
Baseline (Week 0) and post-intervention (Week 6)
|
|
Biodex Postural Stability
Zeitfenster: Baseline (Week 0) and post-intervention (Week 6)
|
Postural stability will be assessed using the Biodex Balance System.
The selected postural stability index will be recorded under standardized testing conditions, with the same test configuration used at baseline and post-intervention.
|
Baseline (Week 0) and post-intervention (Week 6)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Timed Up and Go (TUG)
Zeitfenster: Baseline (Week 0) and post-intervention (Week 6)
|
Functional mobility will be assessed using the 3-meter Timed Up and Go test.
The time required for the participant to stand up from a chair, walk 3 meters, turn, return to the chair, and sit down will be recorded in seconds.
Lower completion time indicates better functional mobility.
|
Baseline (Week 0) and post-intervention (Week 6)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. September 2026
Primärer Abschluss (Geschätzt)
1. Dezember 2026
Studienabschluss (Geschätzt)
1. Dezember 2026
Studienanmeldedaten
Zuerst eingereicht
9. September 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
9. September 2026
Zuerst gepostet (Tatsächlich)
15. September 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
15. September 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. September 2026
Zuletzt verifiziert
1. September 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- TOMA-PT-2026-005
Plan für individuelle Teilnehmerdaten (IPD)
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NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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