NCT06899698

INSPIRATORY MUSCLE TRAINER ON AUTONOMIC MODULATION AND PULMONARY FUNCTION

EFFECT OF INSPIRATORY MUSCLE TRAINER ON AUTONOMIC MODULATION AND PULMONARY FUNCTION IN PATIENTS WITH STROKE

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Adly A Adam · Academic / Other
• Sex: Male
• Age: 55 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
OTHER	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.
OTHER	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'.

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2025-03-28
• Last updated: 2025-03-28

Locations

1 site across 1 country: Egypt