- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07821255
Effect of Diaphragmatic Breathing Training on Trunk Control and Postural Stability in Individuals With Chronic Stroke
Effect of Diaphragmatic Breathing Training on Trunk Control and Postural Stability in Individuals With Chronic Stroke: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: fatma shehata mohamad, phD
- Phone Number: +201014001578
- Email: Fatma.mohamad@the.suezuni.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline (Week 0) and post-intervention (Week 6)
|
|
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.
|
Baseline (Week 0) and post-intervention (Week 6)
|
|
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.
|
Baseline (Week 0) and post-intervention (Week 6)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed Up and Go (TUG)
Time Frame: 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)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TOMA-PT-2026-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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