Hemiplegic StrokeNCT06899698
INSPIRATORY MUSCLE TRAINER ON AUTONOMIC MODULATION AND PULMONARY FUNCTION
A study testing Inspiratory muscle training and Traditional Training in people with Hemiplegic Stroke, run by Adly A Adam at 1 site in Egypt.
Trial summary
Stroke individuals with hemiplegia often display difficulties in mobility, cardiopulmonary function...etc. All stroke patients had restrictive pulmonary dysfunction. Therefore, respiratory training improves their respiratory capacity, and orthostatic stress mediated respiratory, cardiovascular and autonomic response. Read more about this study
- Who is it for?
- Ages 55 to 65 years, men only
- Conditions the study is for
- Hemiplegic Stroke
- What is being tested?
- Inspiratory muscle training and Traditional Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 1 Dec 2025
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic hemiplegic post stroke patients 'at least 6months'
- Men.
- Age ranged 55-65years old.
- Body mass index ranged from 29.9- 34.9 kg/m2
- Mini-Mental State Examination (MMSE) scores of 23-27 indicate mild cognitive impairment
- Did not participate in any selective exercise program for the respiratory muscles before.
- Participants suffering from orthostatic hypotension a systolic BP decline ≥20 mm Hg or a diastolic BP decline ≥10 mm Hg on position change from sitting to standing.
- Smokers will be defined as those (who had smoked >400 cigarettes in their lifetime)
Who cannot join
- Unstable cardiovascular problems.
- Asthmatic patient.
- Implanted pacemaker
- Patients with chest infection.
- Patients with pleural diseases.
- Primary valvular disease.
Show all 14Show fewer
- History of spontaneous pneumothorax.
- Clinically significant peripheral vascular disease.
- Severe anemia being unable to follow RMT instructions or complete the questionnaires of the study due to cognitive impairment .
- Previous lung surgery.
- Long-term oxygen treatment.
- Patients with chronic renal failure.
- Any patient enrolled in an anther research study for at least 30 days.
- Facial affection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Physical Therapy Faculty
Giza, Dokki, 12612
Zeinab Mohamed Helmy, Professor of Physical Thera[y/, +2035676103 ext. 103, Info@pt.cu.edu.eg
About this study
Official title: EFFECT OF INSPIRATORY MUSCLE TRAINER ON AUTONOMIC MODULATION AND PULMONARY FUNCTION IN PATIENTS WITH STROKE
Stroke individuals with hemiplegia often display difficulties in mobility, cardiopulmonary function...etc. All stroke patients had restrictive pulmonary dysfunction. Therefore, respiratory training improves their respiratory capacity, and orthostatic stress mediated respiratory, cardiovascular and autonomic response. Respiratory muscle training interventions are efficient in terms of pulmonary functional parameters. In advanced line, this study will be conducted to evaluate inspiratory muscle trainer effect on autonomic modulation and pulmonary function in stroke patients.
Read the detailed description
The second trigger of death and the most frequent life-threatening neurological disease are now strokes. Stroke is the third main cause of the death \& disability in Egypt. According to world health organization; from the total world's population, nearly 18.6 had severe disability and 79.7 million had moderate long-term disability. Respiratory dysfunction is a common complication of stroke, with an incidence of over 60%. Despite the high prevalence of stroke-induced respiratory dysfunction, how disordered breathing influences recovery and cognitive outcomes after ischemic stroke is unknown.
Patients with hemiplegia exhibited diminished respiratory muscle strength and pulmonary function at a more severe motor dysfunction level. Impaired inspiratory muscle strength was associated with reduced balance ability and limitations in activities required for daily living.
in the same line this study will be conducted to find out the effect of inspiratory muscle trainer on autonomic modulation and pulmonary function in patients with stroke.
Sixty chronic hemiplegic patients who aged from 55:65 years old will be recruited, and randomly divided into 2 equal groups; study group will receive threshold inspiratory muscle trainer for 8 weeks (24 sessions) and their medications, and traditional training, where control group will receive their prescribed medications in addition to the same traditional training.
- Conditions
- Hemiplegic Stroke
- Being tested
- Inspiratory muscle training, Traditional Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingOther
Only participants in the Study group 'Thirty chronic hemiplegic patients with mild cognitive impairment, and suffering from orthostatic hypotension' will receive inspiratory muscle training using Respiratory muscle strength: Threshold Inspiratory muscle trainer (TIMT): Philips Respironics model (Tayland- B00J417PHM), for 30 minutes per day for at least 3 days a week for 8 weeks.
Traditional TrainingOther
Both the study and control group 'Sixty chronic hemiplegic patients with mild cognitive impairment, and suffering from orthostatic hypotension' will receive a. bobath technique 'passive mobilization associated with tactile and proprioceptive stimuli aims to inhibits spasticity'; b. Proprioceptive neuromuscular facilitation 'based on spiral and diagonal patterns of movements in line to achieve normal movements' c. Rood technique 'focuses on the developmental sequence of recovery (from basic to complex) and the use of sensory stimulation to facilitate movement and postural responses' d. Johnstone method 'includes positioning and splinting to inhibit abnormal patterns and controlling tone to restore central control' e. Functional electrical stimulation; f. Balance training, j. Pelvic, and gait training, h. Activities of daily living, and finally, g. Sensrimotor training 'Active and active-assistive range-of motion exercises, Graded activities Start with easy activities'.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Thirty chronic hemiplegic patients with mild cognitive impairment, and suffering from orthostatic hypotension will receive inspiratory muscle training for 30 minutes per day for at least 3 days a week for 8 weeks, medications, and traditional training along 8 weeks. Receives: Other: Inspiratory muscle training; Other: Traditional Training |
| Control Group | Other | Thirty chronic hemiplegic patients with mild cognitive impairment, and suffering from orthostatic hypotension will receive their medications, and traditional training along 8 weeks. Receives: Other: Traditional Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
systolic, diastolic blood pressure and mean arterial blood pressure those will be measure using Mercury sphygmomanometer and stethoscope (China ,1600G004).
Measured: Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).
Pulmonary Function test
Pulmonary function test using Spirometry will be used to evaluate (Compact; Vitalograph; Buckingham, England) FVC, FEV1, FEV1 / FVC will be measured three times per each time of evaluation on a computerized spirometer
Measured: Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).
Secondary outcomes (2)
Functional capacity and orthostatic hypotension assessment
Sit to stand test will be used for functional capacity assessment in addition to assessing the blood pressure from sitting to standing positions before and after treatment
Measured: Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).
Cognitive function
Cognitive function will be assessed using the Mini-Mental State Examination (MMSE) scores that is a tool that can be used to systematically and thoroughly assess mental status. It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment. The MMSE takes only 5-10 minutes to administer and is therefore practical to use repeatedly and routinely.
Measured: Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic 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
- Brief summary; the purpose of the study is to evaluate the effect of inspiratory muscle trainer on autonomic modulation and pulmonary function in patients with stroke. Good evidence exists that respiratory muscle strength is significantly impaired after stroke because of decreased cortico-respiratory outflow from the damaged cortex. Inspiratory muscle training (IMT) improves the interplay of the respiratory pump, hemodynamic, cerebrovascular and postural balance responses. Sixty chronic hemiplegic patients will be randomly allocated into; Study group will receive IMT, their medications in addition to the traditional training for eight weeks; Control group will receive their medications in addition to the traditional training for eight weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adly A Adam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adly A Adam, Cairo University
- Investigators
- Sara Mohamed Ahmed, Bachelor of Physical Therapy, Principal investigator, Physical Therapy FacultyEbtesam Nabil Abdel Mohsen, Lecturer of Physical Therapy, Study director, Physical Therapy FacultyEbtesam Mohamed Fahmy, Professor of Neurology, Study director, faculty of medicineZeinab Mohamed Helmy, Professor of Physical Therapy, Study chair, faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899698
- Sponsor's protocol ID
- P.T.REC/012/005300
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- 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 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF INSPIRATORY MUSCLE TRAINER ON AUTONOMIC MODULATION AND PULMONARY FUNCTION IN PATIENTS WITH STROKE
- ClinicalTrials.gov ID
- NCT06899698
- Acronym / sponsor ID
- P.T.REC/012/005300
- Conditions
- Hemiplegic Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Adly A AdamUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 28 Mar 2025 (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.
Stroke individuals with hemiplegia often display difficulties in mobility, cardiopulmonary function...etc. All stroke patients had restrictive pulmonary dysfunction. Therefore, respiratory training improves their respiratory capacity, and orthostatic stress mediated respiratory, cardiovascular and autonomic response. Respiratory muscle training interventions are efficient in terms of pulmonary functional parameters. In advanced line, this study will be conducted to evaluate inspiratory muscle trainer effect on autonomic modulation and pulmonary function in stroke patients.
Detailed description
The second trigger of death and the most frequent life-threatening neurological disease are now strokes. Stroke is the third main cause of the death \& disability in Egypt. According to world health organization; from the total world's population, nearly 18.6 had severe disability and 79.7 million had moderate long-term disability. Respiratory dysfunction is a common complication of stroke, with an incidence of over 60%. Despite the high prevalence of stroke-induced respiratory dysfunction, how disordered breathing influences recovery and cognitive outcomes after ischemic stroke is unknown.
Patients with hemiplegia exhibited diminished respiratory muscle strength and pulmonary function at a more severe motor dysfunction level. Impaired inspiratory muscle strength was associated with reduced balance ability and limitations in activities required for daily living.
in the same line this study will be conducted to find out the effect of inspiratory muscle trainer on autonomic modulation and pulmonary function in patients with stroke.
Sixty chronic hemiplegic patients who aged from 55:65 years old will be recruited, and randomly divided into 2 equal groups; study group will receive threshold inspiratory muscle trainer for 8 weeks (24 sessions) and their medications, and traditional training, where control group will receive their prescribed medications in addition to the same traditional training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Brief summary; the purpose of the study is to evaluate the effect of inspiratory muscle trainer on autonomic modulation and pulmonary function in patients with stroke. Good evidence exists that respiratory muscle strength is significantly impaired after stroke because of decreased cortico-respiratory outflow from the damaged cortex. Inspiratory muscle training (IMT) improves the interplay of the respiratory pump, hemodynamic, cerebrovascular and postural balance responses. Sixty chronic hemiplegic patients will be randomly allocated into; Study group will receive IMT, their medications in addition to the traditional training for eight weeks; Control group will receive their medications in addition to the traditional training for eight weeks.
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Inspiratory muscle training, Other: Traditional TrainingThirty chronic hemiplegic patients with mild cognitive impairment, and suffering from orthostatic hypotension will receive inspiratory muscle training for 30 minutes per day for at least 3 days a week for 8 weeks, medications, and traditional training along 8 weeks. |
| Control Group | Other | Other: Traditional TrainingThirty chronic hemiplegic patients with mild cognitive impairment, and suffering from orthostatic hypotension will receive their medications, and traditional training along 8 weeks. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Chronic hemiplegic post stroke patients 'at least 6months'
- Men.
- Age ranged 55-65years old.
- Body mass index ranged from 29.9- 34.9 kg/m2
- Mini-Mental State Examination (MMSE) scores of 23-27 indicate mild cognitive impairment
Key exclusion criteria (14 listed)
- Unstable cardiovascular problems.
- Asthmatic patient.
- Implanted pacemaker
- Patients with chest infection.
- Patients with pleural diseases.
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 |
|---|---|---|
| Inspiratory muscle trainingOnly participants in the Study group 'Thirty chronic hemiplegic patients with mild cognitive impairment, and suffering from orthostatic hypotension' will receive inspiratory muscle training using Respiratory muscle strength: Threshold Inspiratory muscle trainer (TIMT): Philips Respironics model (Tayland- B00J417PHM), for 30 minutes per day for at least 3 days a week for 8 weeks. | Other | Study Group |
| Traditional TrainingBoth the study and control group 'Sixty chronic hemiplegic patients with mild cognitive impairment, and suffering from orthostatic hypotension' will receive a. bobath technique 'passive mobilization associated with tactile and proprioceptive stimuli aims to inhibits spasticity'; b. Proprioceptive neuromuscular facilitation 'based on spiral and diagonal patterns of movements in line to achieve normal movements' c. Rood technique 'focuses on the developmental sequence of recovery (from basic to complex) and the use of sensory stimulation to facilitate movement and postural responses' d. Johnstone method 'includes positioning and splinting to inhibit abnormal patterns and controlling tone to restore central control' e. Functional electrical stimulation; f. Balance training, j. Pelvic, and gait training, h. Activities of daily living, and finally, g. Sensrimotor training 'Active and active-assistive range-of motion exercises, Graded activities Start with easy activities'. | Other | Control Group, Study Group |
Primary outcome
Blood Pressure
Time frame: Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).
systolic, diastolic blood pressure and mean arterial blood pressure those will be measure using Mercury sphygmomanometer and stethoscope (China ,1600G004).
Pulmonary Function test
Time frame: Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).
Pulmonary function test using Spirometry will be used to evaluate (Compact; Vitalograph; Buckingham, England) FVC, FEV1, FEV1 / FVC will be measured three times per each time of evaluation on a computerized spirometer
2 secondary outcomes
Functional capacity and orthostatic hypotension assessment
Time frame: Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).
Cognitive function
Time frame: Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).
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 28 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Hemiplegic Stroke
Active, not recruitingObservational study
Focused Intensive Repeated Stepping During Inpatient Rehabilitation Poststroke - A Quality Improvement Project
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Locomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke
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Neuro-MoD: Neuroplasticity With Motor Development
Perinatal Brain Injury
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High-Intensity Laser Therapy in Hemiplegic Shoulder Pain
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Repetitive Transcranial Magnetic Stimulation in Patients With Hemiplegic Stroke
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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.
Sara Mohamed Ahmed, Bachelor of Physical Therapy principal investigator
Physical Therapy Faculty
Ebtesam Nabil Abdel Mohsen, Lecturer of Physical Therapy study director
Physical Therapy Faculty
Ebtesam Mohamed Fahmy, Professor of Neurology study director
faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training and Traditional Training in people with Hemiplegic Stroke, run by Adly A Adam at 1 site in Egypt.
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 8 inclusion and 14 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 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Sara Mohamed Ahmed, Bachalor (+2035676103 ext. 103, Info@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).). The study lists 2 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 28 Mar 2025.