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Starting soon Not applicable

INSPIRATORY MUSCLE TRAINER ON AUTONOMIC MODULATION AND PULMONARY FUNCTION

NCT06899698 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2025-04-01
Last updated
2025-03-28

Condition(s) studied

Hemiplegic Stroke

Investigational drug(s) / intervention(s)

Inspiratory muscle trainingTraditional Training

Inspiratory muscle training: 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 Training: 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 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. 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.

Eligibility

Sex
MALE
Min age
55 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * 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) Exclusion Criteria: * Unstable cardiovascular problems. * Asthmatic patient. * Implanted pacemaker * Patients with chest infection. * Patients with pleural diseases. * Primary valvular disease. * 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

Primary outcome measure(s)

  • Blood Pressure — 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 — 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

Trial sites (1)

FacilityCityRegionStatus
Physical Therapy Faculty Giza Dokki
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06899698 on ClinicalTrials.gov ↗ ← All trials in Egypt