Chronic Stroke PatientNCT07727902
Functional Inspiratory Muscle Training for Gait Recovery in Patients With Chronic Stroke
A study testing Functional Inspiratory Muscle Training and Conventional Inspiratory Muscle Training in people with Chronic Stroke Patient and Stroke Rehabilitation, run by Cairo University.
Trial summary
The purpose of this randomized controlled trial is to evaluate the effect of functional inspiratory muscle training (F-IMT) on spatiotemporal gait parameters in patients with chronic stroke. Read more about this study
- Who is it for?
- Ages 55 to 65 years
- Conditions the study is for
- Chronic Stroke Patient, Stroke Rehabilitation
- What is being tested?
- Functional Inspiratory Muscle Training and Conventional Inspiratory Muscle Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 20 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 55 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 55 and 65 years.
- Both male and female participants.
- Chronic stroke patients (>6 months after stroke onset), including ischemic or hemorrhagic stroke confirmed by neuroimaging.
- Moderate gait impairment with gait speed ranging from 0.4 to 0.8 m/s.
- Ability to understand instructions and communicate sufficiently to participate in the study procedures.
- Breathing spontaneously without ventilatory support.
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- No thoracic or abdominal surgery within the previous 6 months.
- No facial palsy, or mild facial palsy without limitation of labial occlusion.
- Ability to walk independently for at least 10 meters with or without an assistive device.
- Willingness to participate and provide written informed consent.
Who cannot join
- Unstable cardiovascular disease (e.g., recent myocardial infarction, uncontrolled hypertension, decompensated heart failure).
- Uncontrolled metabolic disease or poorly controlled diabetes mellitus.
- Severe pulmonary disease or respiratory impairment (e.g., severe COPD, hypoxemia, chronic cough, or sputum retention).
- Active malignancy.
- Presence of nasal feeding tube, tracheostomy tube, or any condition preventing implementation of the study procedures.
- Severe musculoskeletal disorders affecting gait performance (e.g., lower limb fracture, severe osteoarthritis, or amputation).
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- Significant cognitive or communication impairment preventing reliable participation.
- Severe spasticity (Modified Ashworth Scale >3) or fixed contractures.
- Other neurological disorders affecting gait (e.g., Parkinson's disease, multiple sclerosis, spinal cord injury).
- Severe obesity (BMI ≥35 kg/m²) that may interfere with gait assessment or exercise performance.
- Previous participation in inspiratory muscle training programs.
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 Functional Inspiratory Muscle Training on Spatiotemporal Gait Parameters in Patients With Chronic Stroke
The purpose of this randomized controlled trial is to evaluate the effect of functional inspiratory muscle training (F-IMT) on spatiotemporal gait parameters in patients with chronic stroke. Sixty participants with chronic stroke will be randomly assigned to either a functional inspiratory muscle training group or a conventional inspiratory muscle training group. Both groups will receive the same conventional rehabilitation program for 8 weeks. The primary outcome is spatiotemporal gait parameters measured using the STEADYS gait assessment system. Secondary outcomes include exercise capacity assessed by the Six-Minute Walk Test (6MWT) and health-related quality of life assessed using the EuroQol Five-Dimension (EQ-5D) questionnaire.
Read the detailed description
Stroke is a leading cause of long-term disability worldwide and is frequently associated with persistent impairments in walking ability. Patients with chronic stroke commonly demonstrate reduced gait speed, shorter stride length, impaired gait symmetry, prolonged double-support time, and decreased functional mobility. These gait abnormalities are associated with impaired trunk control, respiratory muscle weakness, reduced exercise tolerance, and diminished quality of life. Although conventional rehabilitation improves motor function, many patients continue to experience limitations in walking performance.
Inspiratory muscle training (IMT) has been shown to improve inspiratory muscle strength, pulmonary function, exercise capacity, and trunk stability in individuals with neurological disorders. Functional inspiratory muscle training (F-IMT) integrates inspiratory muscle training with functional rehabilitation exercises, allowing simultaneous activation of respiratory and postural muscles during task-oriented activities. This integrated approach may enhance motor control and walking performance beyond conventional IMT alone.
This study is a prospective, single-center, randomized controlled trial involving 60 participants with chronic stroke. Eligible participants will be randomly allocated in a 1:1 ratio to one of two intervention groups. The intervention group will receive functional inspiratory muscle training using a Threshold IMT device integrated with functional rehabilitation exercises at an intensity of 50% of maximal inspiratory pressure (MIP), five sessions per week for 8 weeks. The control group will receive conventional inspiratory muscle training using the same device, training intensity, frequency, and duration without integration into functional activities. Both groups will receive an identical standardized conventional rehabilitation program throughout the intervention period.
The primary outcome will be changes in spatiotemporal gait parameters measured using the STEADYS gait assessment system, including gait speed, cadence, stance time, swing time, double-support time, and stride length. Secondary outcomes will include functional exercise capacity measured using the Six-Minute Walk Test (6MWT) and health-related quality of life measured using the EuroQol Five-Dimension (EQ-5D) questionnaire. Outcome assessments will be performed at baseline and after completion of the 8-week intervention.
The findings of this trial will provide evidence regarding the effectiveness of functional inspiratory muscle training as an adjunct to conventional rehabilitation for improving gait performance, exercise capacity, and quality of life in individuals with chronic stroke.
- Conditions
- Chronic Stroke Patient, Stroke Rehabilitation
- Being tested
- Functional Inspiratory Muscle Training, Conventional Inspiratory Muscle Training
- Keywords
- Chronic stroke, Stroke rehabilitation, Functional inspiratory muscle training, Inspiratory muscle training, Respiratory muscle training, Gait parameters, Spatiotemporal gait analysis, Gait rehabilitation, Walking ability, Functional capacity, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Inspiratory Muscle TrainingBehavioural
Functional inspiratory muscle training combines inspiratory muscle loading with functional activities to improve respiratory muscle performance, trunk stability, and functional mobility. Training will be performed at 50% of maximal inspiratory pressure using a Threshold IMT device for 30 minutes per session, 5 days per week, for 8 weeks.
Conventional Inspiratory Muscle TrainingBehavioural
Conventional inspiratory muscle training will be performed using a Threshold IMT device at 50% of maximal inspiratory pressure for 30 minutes per session, 5 days per week, for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Functional Inspiratory Muscle Training Group | Experimental | Participants will receive functional inspiratory muscle training combined with a standardized conventional rehabilitation program. Functional inspiratory muscle training integrates inspiratory muscle loading with functional activities and will be performed using the Threshold IMT device at 50% of maximal inspiratory pressure (MIP), 5 days per week for 8 weeks. Each session will last approximately 30 minutes (3 sets of 10-15 repetitions). Participants will also receive conventional rehabilitation including range of motion exercises, muscle tone management, strengthening and endurance training, transfer training, task-oriented activities, gait training, and activities of daily living training. Receives: Behavioral: Functional Inspiratory Muscle Training |
| Conventional Inspiratory Muscle Training Group | Active comparator | Participants will receive conventional inspiratory muscle training combined with the same standardized conventional rehabilitation program. Inspiratory muscle training will be performed using the Threshold IMT device at 50% of maximal inspiratory pressure (MIP), 5 days per week for 8 weeks. Each session will last approximately 30 minutes (3 sets of 10-15 repetitions). The conventional rehabilitation program will include range of motion exercises, muscle tone management, strengthening and endurance training, transfer training, task-oriented activities, gait training, and activities of daily living training. Receives: Behavioral: Conventional Inspiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gait Speed
Gait speed assessed using the STEADYS gait assessment system and reported in meters per second (m/s).
Measured: Time Frame: Baseline (Day 1) and end of Week 8
Change in Cadence
Cadence assessed using the STEADYS gait assessment system and reported in steps per minute (steps/min).
Measured: Baseline (Day 1) and end of Week 8
Change in Stance Time
Stance time assessed using the STEADYS gait assessment system and reported as a percentage (%) of the gait cycle.
Measured: Baseline (Day 1) and end of Week 8
Change in Swing Time
Swing time assessed using the STEADYS gait assessment system and reported as a percentage (%) of the gait cycle.
Measured: Baseline (Day 1) and end of Week 8
Change in Double Support Time
Double support time assessed using the STEADYS gait assessment system and reported as a percentage (%) of the gait cycle.
Measured: Baseline (Day 1) and end of Week 8
Change in Stride Length
Stride length assessed using the STEADYS gait assessment system and reported in meters (m).
Measured: Baseline (Day 1) and end of Week 8
Secondary outcomes (2)
Change in Functional Exercise Capacity
Functional exercise capacity assessed using the Six-Minute Walk Test (6MWT). The outcome is the total distance walked during 6 minutes, reported in meters (m). Higher values indicate better functional exercise capacity.
Measured: Baseline (Day 1) and end of Week 8
Change in Health-Related Quality of Life
Health-related quality of life assessed using the EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L). The EQ-5D-5L Index Score ranges from less than 0 (health states worse than death) to 1.0 (perfect health). Higher scores indicate better health-related quality of life.
Measured: Baseline (Day 1) and end of Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Stroke PatientStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Participants will be randomly assigned into two parallel groups. The functional inspiratory muscle training group will receive functional inspiratory muscle training combined with conventional rehabilitation, while the active comparator group will receive conventional inspiratory muscle training combined with the same rehabilitation program. Both groups will receive interventions for 8 weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Taha Mohamed Taha, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727902
- Sponsor's protocol ID
- CU-PT-FIMT-STROKE-2026
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- 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 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Functional Inspiratory Muscle Training on Spatiotemporal Gait Parameters in Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT07727902
- Acronym / sponsor ID
- CU-PT-FIMT-STROKE-2026
- Conditions
- Chronic Stroke Patient, Stroke Rehabilitation
- Keywords
- Chronic stroke, Stroke rehabilitation, Functional inspiratory muscle training, Inspiratory muscle training, Respiratory muscle training, Gait parameters, Spatiotemporal gait analysis, Gait rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 27 Jul 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.
The purpose of this randomized controlled trial is to evaluate the effect of functional inspiratory muscle training (F-IMT) on spatiotemporal gait parameters in patients with chronic stroke. Sixty participants with chronic stroke will be randomly assigned to either a functional inspiratory muscle training group or a conventional inspiratory muscle training group. Both groups will receive the same conventional rehabilitation program for 8 weeks. The primary outcome is spatiotemporal gait parameters measured using the STEADYS gait assessment system. Secondary outcomes include exercise capacity assessed by the Six-Minute Walk Test (6MWT) and health-related quality of life assessed using the EuroQol Five-Dimension (EQ-5D) questionnaire.
Detailed description
Stroke is a leading cause of long-term disability worldwide and is frequently associated with persistent impairments in walking ability. Patients with chronic stroke commonly demonstrate reduced gait speed, shorter stride length, impaired gait symmetry, prolonged double-support time, and decreased functional mobility. These gait abnormalities are associated with impaired trunk control, respiratory muscle weakness, reduced exercise tolerance, and diminished quality of life. Although conventional rehabilitation improves motor function, many patients continue to experience limitations in walking performance.
Inspiratory muscle training (IMT) has been shown to improve inspiratory muscle strength, pulmonary function, exercise capacity, and trunk stability in individuals with neurological disorders. Functional inspiratory muscle training (F-IMT) integrates inspiratory muscle training with functional rehabilitation exercises, allowing simultaneous activation of respiratory and postural muscles during task-oriented activities. This integrated approach may enhance motor control and walking performance beyond conventional IMT alone.
This study is a prospective, single-center, randomized controlled trial involving 60 participants with chronic stroke. Eligible participants will be randomly allocated in a 1:1 ratio to one of two intervention groups. The intervention group will receive functional inspiratory muscle training using a Threshold IMT device integrated with functional rehabilitation exercises at an intensity of 50% of maximal inspiratory pressure (MIP), five sessions per week for 8 weeks. The control group will receive conventional inspiratory muscle training using the same device, training intensity, frequency, and duration without integration into functional activities. Both groups will receive an identical standardized conventional rehabilitation program throughout the intervention period.
The primary outcome will be changes in spatiotemporal gait parameters measured using the STEADYS gait assessment system, including gait speed, cadence, stance time, swing time, double-support time, and stride length. Secondary outcomes will include functional exercise capacity measured using the Six-Minute Walk Test (6MWT) and health-related quality of life measured using the EuroQol Five-Dimension (EQ-5D) questionnaire. Outcome assessments will be performed at baseline and after completion of the 8-week intervention.
The findings of this trial will provide evidence regarding the effectiveness of functional inspiratory muscle training as an adjunct to conventional rehabilitation for improving gait performance, exercise capacity, and quality of life in individuals with chronic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned into two parallel groups. The functional inspiratory muscle training group will receive functional inspiratory muscle training combined with conventional rehabilitation, while the active comparator group will receive conventional inspiratory muscle training combined with the same rehabilitation program. Both groups will receive interventions for 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Functional Inspiratory Muscle Training Group | Experimental | Behavioral: Functional Inspiratory Muscle TrainingParticipants will receive functional inspiratory muscle training combined with a standardized conventional rehabilitation program. Functional inspiratory muscle training integrates inspiratory muscle loading with functional activities and will be performed using the Threshold IMT device at 50% of maximal inspiratory pressure (MIP), 5 days per week for 8 weeks. Each session will last approximately 30 minutes (3 sets of 10-15 repetitions). Participants will also receive conventional rehabilitation including range of motion exercises, muscle tone management, strengthening and endurance training, transfer training, task-oriented activities, gait training, and activities of daily living training. |
| Conventional Inspiratory Muscle Training Group | Active comparator | Behavioral: Conventional Inspiratory Muscle TrainingParticipants will receive conventional inspiratory muscle training combined with the same standardized conventional rehabilitation program. Inspiratory muscle training will be performed using the Threshold IMT device at 50% of maximal inspiratory pressure (MIP), 5 days per week for 8 weeks. Each session will last approximately 30 minutes (3 sets of 10-15 repetitions). The conventional rehabilitation program will include range of motion exercises, muscle tone management, strengthening and endurance training, transfer training, task-oriented activities, gait training, and activities of daily living training. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients aged between 55 and 65 years.
- Both male and female participants.
- Chronic stroke patients (>6 months after stroke onset), including ischemic or hemorrhagic stroke confirmed by neuroimaging.
- Moderate gait impairment with gait speed ranging from 0.4 to 0.8 m/s.
- Ability to understand instructions and communicate sufficiently to participate in the study procedures.
Key exclusion criteria (11 listed)
- Unstable cardiovascular disease (e.g., recent myocardial infarction, uncontrolled hypertension, decompensated heart failure).
- Uncontrolled metabolic disease or poorly controlled diabetes mellitus.
- Severe pulmonary disease or respiratory impairment (e.g., severe COPD, hypoxemia, chronic cough, or sputum retention).
- Active malignancy.
- Presence of nasal feeding tube, tracheostomy tube, or any condition preventing implementation of the study procedures.
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 |
|---|---|---|
| Functional Inspiratory Muscle TrainingFunctional inspiratory muscle training combines inspiratory muscle loading with functional activities to improve respiratory muscle performance, trunk stability, and functional mobility. Training will be performed at 50% of maximal inspiratory pressure using a Threshold IMT device for 30 minutes per session, 5 days per week, for 8 weeks. | Behavioural | Functional Inspiratory Muscle Training Group |
| Conventional Inspiratory Muscle TrainingConventional inspiratory muscle training will be performed using a Threshold IMT device at 50% of maximal inspiratory pressure for 30 minutes per session, 5 days per week, for 8 weeks. | Behavioural | Conventional Inspiratory Muscle Training Group |
Primary outcome
Change in Gait Speed
Time frame: Time Frame: Baseline (Day 1) and end of Week 8
Gait speed assessed using the STEADYS gait assessment system and reported in meters per second (m/s).
Change in Cadence
Time frame: Baseline (Day 1) and end of Week 8
Cadence assessed using the STEADYS gait assessment system and reported in steps per minute (steps/min).
Change in Stance Time
Time frame: Baseline (Day 1) and end of Week 8
Stance time assessed using the STEADYS gait assessment system and reported as a percentage (%) of the gait cycle.
Change in Swing Time
Time frame: Baseline (Day 1) and end of Week 8
Swing time assessed using the STEADYS gait assessment system and reported as a percentage (%) of the gait cycle.
Change in Double Support Time
Time frame: Baseline (Day 1) and end of Week 8
Double support time assessed using the STEADYS gait assessment system and reported as a percentage (%) of the gait cycle.
Change in Stride Length
Time frame: Baseline (Day 1) and end of Week 8
Stride length assessed using the STEADYS gait assessment system and reported in meters (m).
2 secondary outcomes
Change in Functional Exercise Capacity
Time frame: Baseline (Day 1) and end of Week 8
Change in Health-Related Quality of Life
Time frame: Baseline (Day 1) and end of Week 8
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 27 Jul 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 Functional Inspiratory Muscle Training and Conventional Inspiratory Muscle Training in people with Chronic Stroke Patient and Stroke Rehabilitation, run by Cairo University.
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 10 inclusion and 11 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 27 Jul 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 Shimaa Taha, PhD (+201021088610 ext. +201021088610, shimaa.taha@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gait Speed (time frame: Time Frame: Baseline (Day 1) and end of Week 8). The study lists 6 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 27 Jul 2026.