Health TrialsbyHealthPanel

INSPIRATORY MUSCLE TRAINER ON AUTONOMIC MODULATION AND PULMONARY FUNCTION

ConditionHemiplegic Stroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age55-65
SponsorAdly A Adam

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Unstable cardiovascular problems.

Asthmatic patient.

Implanted pacemaker

Patients with chest infection.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inspiratory muscle training

    Other intervention

    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

    Other intervention

    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'.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Study GroupExperimental treatment 2 interventions
Group B: Control GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

Blood Pressure

systolic, diastolic blood pressure and mean arterial blood pressure those will be measure using Mercury sphygmomanometer and stethoscope (China ,1600G004).

Time frame
Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).
2

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

Time frame
Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).

Secondary outcomes

1

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

Time frame
Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).
2

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.

Time frame
Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Adly A Adam

Lead sponsor

Cairo University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: