- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06379854
Trunk Rotation And Lateral Flexion Exercises In Stroke Patients
Effects Of Trunk Rotation And Lateral Flexion Exercises On Peak Cough Flow And Chest Expansion In Stroke Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, PhD
- Phone Number: 03324390125
- Email: Imran.amjad@riphah.edu.pk
Study Locations
-
-
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Islamabad, Pakistan, 44080
- Recruiting
- Shahida Khaliq Health Centre
-
Contact:
- Sara Jahan, MSPT
- Phone Number: +923415182331
- Email: saira.jahan@riphah.edu.pk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: chest physiotherapy
we take 2 groups in one group only chest physiotherapy introduce
|
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
|
|
Active Comparator: trunk rotation exercises,deep diaphragmatic also chest physiotherapy
But in 2nd group chest physiotherapy with trunk rotation exercises and deep diaphragmatic breathing exercises alo introduce.
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trunk Impairment Scale:
Time Frame: 4th week
|
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
|
|
Peak Flow Meter
Time Frame: 4th week
|
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
|
|
Chest Expansion:
Time Frame: 4th week
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aruba Saeed, Phd*, Riphah International University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Yew KS, Cheng EM. Diagnosis of acute stroke. Am Fam Physician. 2015 Apr 15;91(8):528-36.
- 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.
- Jeong, J.-H., Brain and lung: lung injury in patients with brain injury. Journal of Neurocritical Care, 2017. 10(1): p. 1-6.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RCRAHS-ISB/REC/MS-PT/01814
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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