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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06379854
Other study ID # RCRAHS-ISB/REC/MS-PT/01814
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date June 2024

Study information

Verified date April 2024
Source Riphah International University
Contact Imran amjad, phd
Phone 03324390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study we want to introduce the beneficiary combine effects of chest mobilization and chest physiotherapy exercises by using cough peak flow meter and chest expansion in stroke patients. by using theses combine exercises physiotherapist can develop target rehabilitation strategies for stroke survivors.


Description:

Stroke is a neurological deficit and acute focal injury of the by a vascular cause, including cerebral infarction, intracerebral hemorrhage and subarachnoid hemorrhage and is a major cause of disability and death worldwide. 2nd most deadly cause of death and disability in patients. This disease have long lasting effect on human body and also cause complication of lung function like pneumonia and respiratory distress function syndrome for this purpose to reduce chest complication and neurological defect use of chest physiotherapy and chest mobilization exercises are introduce so that hospital stay of patients reduces and recovery at high speed according to previous studies there is very strong relationship between trunk muscles and respiratory muscle with pulmonary function and physiotherapist can develop target rehabilitation strategies for stroke survivors.however in previous studies age group of patients acute subacute or chronic and diaphragmatic breathing are not included for the improvement of effective cough.


Recruitment information / eligibility

Status Recruiting
Enrollment 54
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group N/A to 50 Years
Eligibility Inclusion Criteria: - Both gender - Age > 50 - Right or left hemiplegic acute stroke patients - Diagnosed cases of stroke patient - Duration: 4 weeks being diagnosed - Can sit with at least 10sec - Can perform exercises with Active Assistance - Patients who easily perform exercises - Patients who response to commands Exclusion Criteria: - Patients with serious comorbidities like cancer - Uncontrolled hypertension SBP > 140mmhg and DBP > 90mmhg - Vitally unstable patient's - Red flags for physiotherapy i.e. sudden dizziness, unexplained pain during exercise, chest pain. - DVT Deep Vein Thrombosis

Study Design


Related Conditions & MeSH terms


Intervention

Other:
chest physiotherapy
Postural Drainage Frequency: 3 sessions/week Intensity: 5 to 10 minutes Time: For 4 weeks Type: chest physiotherapy Percussion F: 3 sessions/week I: 3 to 5 minutes T: For 4 weeks T: chest physiotherapy Vibration F: 3 sessions/week I: 3 to 5 minutes T: For 4 weeks T: chest physiotherapy Shaking F: 3 sessions/week I: 3 to 5 minutes T: For 4 weeks T: chest physiotherapy Huffing and coughing F: 3 sessions/week I: 3 to 5 minutes T: For 4 weeks T: chest physiotherapy
trunk rotation exercises,deep diaphragmatic also chest physiotherapy
Postural Drainage Frequency: 3 sessions/week Intensity: 5 to 10 minutes Time: For 4 weeks Type: chest physiotherapy Percussion F: 3 sessions/week I: 3 to 5 minutes T: For 4 weeks T: chest physiotherapy Vibration F: 3 sessions/week I: 3 to 5 minutes T: For 4 weeks T: chest physiotherapy Shaking F: 3 sessions/week I: 3 to 5 minutes T: For 4 weeks T: chest physiotherapy Huffing and coughing F: 3 sessions/week I: 3 to 5 minutes T: For 4 weeks T: chest physiotherapy Deep Diaphragmatic Breathing Exercise F: 3 sessions/week I: 3 to 5 minutes T: For 4 weeks T: chest physiotherapy TLFROM F: 3 sessions/week I: 5 to 10 minutes T: For 4 weeks T: Mobilization Exercises TFROM F: 3 sessions/week I: 5 to 10 minutes T: For 4 weeks T: Mobilization Exercises

Locations

Country Name City State
Pakistan Shahida Khaliq Health Centre Islamabad

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (18)

Belal, E.S., S. Selim, and A. Mohammad, Detection of airway protective level of the cough reflex in acute stroke patients. The Egyptian Journal of Neurology, Psychiatry and Neurosurgery, 2020. 56(1): p. 1-6.

Farooq A, Venketasubramanian N, Wasay M. Stroke Care in Pakistan. Cerebrovasc Dis Extra. 2021;11(3):118-121. doi: 10.1159/000519554. Epub 2021 Oct 25. — View Citation

Jang SH, Bang HS. Effect of thoracic and cervical joint mobilization on pulmonary function in stroke patients. J Phys Ther Sci. 2016 Jan;28(1):257-60. doi: 10.1589/jpts.28.257. Epub 2016 Jan 30. — View Citation

Jeong, J.-H., Brain and lung: lung injury in patients with brain injury. Journal of Neurocritical Care, 2017. 10(1): p. 1-6.

Jo, M.-R., N.-S. Kim, and J.-H. Jung, The effects of respiratory muscle training on respiratory function, respiratory muscle strength, and cough capacity in stroke patients. Journal of Korean Society of Physical Medicine, 2014. 9(4): p. 399-405.

Johnson W, Onuma O, Owolabi M, Sachdev S. Stroke: a global response is needed. Bull World Health Organ. 2016 Sep 1;94(9):634-634A. doi: 10.2471/BLT.16.181636. No abstract available. — View Citation

Khedr EM, El Shinawy O, Khedr T, Aziz Ali YA, Awad EM. Assessment of corticodiaphragmatic pathway and pulmonary function in acute ischemic stroke patients. Eur J Neurol. 2000 May;7(3):323-30. doi: 10.1046/j.1468-1331.2000.00078.x. — View Citation

Kim, A., et al., Effects of rib cage joint mobilization combined with diaphragmatic breathing exercise on the pulmonary function and chest circumference in patients with stroke. Journal of International Academy of Physical Therapy Research, 2020. 11(3): p. 2113-2118.

Messaggi-Sartor M, Guillen-Sola A, Depolo M, Duarte E, Rodriguez DA, Barrera MC, Barreiro E, Escalada F, Orozco-Levi M, Marco E. Inspiratory and expiratory muscle training in subacute stroke: A randomized clinical trial. Neurology. 2015 Aug 18;85(7):564-72. doi: 10.1212/WNL.0000000000001827. Epub 2015 Jul 15. — View Citation

Park HY, Hwang UJ, Kwon OY. Correlation between trunk rotation and lateral flexion range of motion, peak cough flow, and chest expansion in stroke patients. Physiother Res Int. 2023 Jan;28(1):e1970. doi: 10.1002/pri.1970. Epub 2022 Aug 12. — View Citation

Park, S.J., Effects of inspiratory muscles training plus rib cage mobilization on chest expansion, inspiratory accessory muscles activity and pulmonary function in stroke patients. Applied Sciences, 2020. 10(15): p. 5178.

Rochester CL, Mohsenin V. Respiratory complications of stroke. Semin Respir Crit Care Med. 2002 Jun;23(3):248-60. doi: 10.1055/s-2002-33033. — View Citation

Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7. Erratum In: Stroke. 2019 Aug;50(8):e239. — View Citation

Saini V, Guada L, Yavagal DR. Global Epidemiology of Stroke and Access to Acute Ischemic Stroke Interventions. Neurology. 2021 Nov 16;97(20 Suppl 2):S6-S16. doi: 10.1212/WNL.0000000000012781. — View Citation

Turana Y, Tengkawan J, Chia YC, Nathaniel M, Wang JG, Sukonthasarn A, Chen CH, Minh HV, Buranakitjaroen P, Shin J, Siddique S, Nailes JM, Park S, Teo BW, Sison J, Ann Soenarta A, Hoshide S, Tay JC, Prasad Sogunuru G, Zhang Y, Verma N, Wang TD, Kario K; HOPE Asia Network. Hypertension and stroke in Asia: A comprehensive review from HOPE Asia. J Clin Hypertens (Greenwich). 2021 Mar;23(3):513-521. doi: 10.1111/jch.14099. Epub 2020 Nov 15. — View Citation

Verheyden G, Nieuwboer A, De Wit L, Feys H, Schuback B, Baert I, Jenni W, Schupp W, Thijs V, De Weerdt W. Trunk performance after stroke: an eye catching predictor of functional outcome. J Neurol Neurosurg Psychiatry. 2007 Jul;78(7):694-8. doi: 10.1136/jnnp.2006.101642. Epub 2006 Dec 18. — View Citation

Waseem, M.H., et al., Effectiveness of chest physiotherapy in cerebrovascular accident patients with aspiration pneumonia. Journal of Modern Rehabilitation, 2021. 15(1): p. 47-52.

Yew KS, Cheng EM. Diagnosis of acute stroke. Am Fam Physician. 2015 Apr 15;91(8):528-36. — View Citation

* Note: There are 18 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Trunk Impairment Scale: Changes from baseline this scale is used to assess motor impairment of the trunk after stroke through the evaluation of static and dynamic sitting balance as well as coordination of trunk movement. The initial static sitting balance score 0 means overall total score is O. and full score is 23. This tool is also used to assess progress of trunk movement. 4th week
Primary Peak Flow Meter Changes from baseline Peak flow meter is used to access the peak cough flow in stroke patient's pre and post intervention. Cough peak flow (CPF) measures the maximum expiratory flow during the phase of a cough just after instant opening of the glottis, but peak expiratory flow rate (PEFR) measures maximum expiratory flow, after a full deep inspiration, through an open glottis Normal peak cough flow is about greater than or equal to 270L/min. And the ineffective cough is about less than 160L/min. 4th week
Primary Chest Expansion: A tape measure is used to evaluate the both upper and lower chest expansion in stroke patients. These chest expansions were performed three time and mean value of these are taken. By using tape measure, we determine the difference between rib cage circumference at the end of forced inspiration and at the end of forced expiration. The reliability score for chest expansion is about (0.99) 4th week
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