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Effect of Diaphragmatic Breathing Training on Trunk Control and Postural Stability in Individuals With Chronic Stroke

9 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Studietype

Ingrijpend

Inschrijving (Geschat)

40

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: Diaphragmatic Breathing Training and Conventional Physiotherapy
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.
Actieve vergelijker: 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.
Gedragsmatig: Diaphragmatic Breathing Training and Conventional Physiotherapy
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Trunk Impairment Scale
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Timed Up and Go (TUG)
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

fatma shehata

Medewerkers

Suez University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 december 2026

Studie voltooiing (Geschat)

1 december 2026

Studieregistratiedata

Eerst ingediend

9 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

9 september 2026

Eerst geplaatst (Werkelijk)

15 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 september 2026

Laatste update ingediend die voldeed aan QC-criteria

9 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • TOMA-PT-2026-005

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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