Primary Condition: StrokeNCT07821255
Effect of Diaphragmatic Breathing Training on Trunk Control and Postural Stability in Individuals With Chronic Stroke
A study testing Diaphragmatic Breathing Training and Conventional Physiotherapy in people with Primary Condition: Stroke, run by fatma shehata.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Primary Condition: Stroke
- What is being tested?
- Diaphragmatic Breathing Training and Conventional Physiotherapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 17Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
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
- Conditions
- Primary Condition: Stroke
- Being tested
- Diaphragmatic Breathing Training and Conventional Physiotherapy
- Keywords
- Chronic stroke; trunk control; postural stability; diaphragmatic breathing; physical therapy; balance; functional mobility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic Breathing Training and Conventional PhysiotherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Diaphragmatic Breathing Training and Conventional Physiotherapy | Experimental | 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. Receives: Behavioral: Diaphragmatic Breathing Training and Conventional Physiotherapy |
| Conventional Physiotherapy | Active comparator | 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. Receives: Behavioral: Diaphragmatic Breathing Training and Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk Impairment Scale
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.
Measured: Baseline (Week 0) and post-intervention (Week 6)
Trunk Impairment Scale (TIS)
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.
Measured: Baseline (Week 0) and post-intervention (Week 6)
Biodex Postural Stability
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.
Measured: Baseline (Week 0) and post-intervention (Week 6)
Secondary outcomes (1)
Timed Up and Go (TUG)
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.
Measured: Baseline (Week 0) and post-intervention (Week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Condition: StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- fatma shehata
- Sponsor type
- University, hospital or other
- Collaborators
- Suez University
- Responsible party
- Sponsor-investigator, fatma shehata, Suez University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821255
- Sponsor's protocol ID
- TOMA-PT-2026-005
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diaphragmatic Breathing Training on Trunk Control and Postural Stability in Individuals With Chronic Stroke: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07821255
- Acronym / sponsor ID
- TOMA-PT-2026-005
- Conditions
- Primary Condition: Stroke
- Keywords
- Chronic stroke; trunk control; postural stability; diaphragmatic breathing; physical therapy; balance; functional mobility
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- fatma shehataUniversity, hospital or other
- Collaborators
- Suez University
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Diaphragmatic Breathing Training and Conventional Physiotherapy | Experimental | Behavioral: Diaphragmatic Breathing Training and Conventional PhysiotherapyParticipants 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. |
| Conventional Physiotherapy | Active comparator | Behavioral: Diaphragmatic Breathing Training and Conventional PhysiotherapyParticipants 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragmatic Breathing Training and Conventional PhysiotherapyStandard 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. | Behavioural | Conventional Physiotherapy, Diaphragmatic Breathing Training and Conventional Physiotherapy |
Primary outcome
Trunk Impairment Scale
Time frame: 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.
Trunk Impairment Scale (TIS)
Time frame: 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.
Biodex Postural Stability
Time frame: 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.
1 secondary outcome
Timed Up and Go (TUG)
Time frame: Baseline (Week 0) and post-intervention (Week 6)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic Breathing Training and Conventional Physiotherapy in people with Primary Condition: Stroke, run by fatma shehata.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact fatma shehata mohamad, phD (+201014001578, Fatma.mohamad@the.suezuni.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk Impairment Scale (time frame: Baseline (Week 0) and post-intervention (Week 6)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.