NCT06379854

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 23, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

April 18, 2024

Last Update Submit

April 18, 2024

Conditions

Keywords

strokeTRROM trunk rotation range of motionTLFROM trunk lateral rotation range of motionCPF cough peak flow meter

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

chest physiotherapy

EXPERIMENTAL

we take 2 groups in one group only chest physiotherapy introduce

Other: chest physiotherapy

trunk rotation exercises,deep diaphragmatic also chest physiotherapy

ACTIVE COMPARATOR

But in 2nd group chest physiotherapy with trunk rotation exercises and deep diaphragmatic breathing exercises alo introduce.

Other: trunk rotation exercises,deep diaphragmatic also chest physiotherapy

Interventions

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

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

trunk rotation exercises,deep diaphragmatic also chest physiotherapy

Eligibility Criteria

AgeUp to 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahida Khaliq Health Centre

Islamabad, 44080, Pakistan

RECRUITING

Related Publications (18)

  • 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.

    PMID: 23652265BACKGROUND
  • 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.

    PMID: 27708464BACKGROUND
  • 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.

    PMID: 34785599BACKGROUND
  • 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.

    PMID: 33190399BACKGROUND
  • 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.

    PMID: 34695824BACKGROUND
  • Yew KS, Cheng EM. Diagnosis of acute stroke. Am Fam Physician. 2015 Apr 15;91(8):528-36.

    PMID: 25884860BACKGROUND
  • 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.

    PMID: 16088617BACKGROUND
  • Jeong, J.-H., Brain and lung: lung injury in patients with brain injury. Journal of Neurocritical Care, 2017. 10(1): p. 1-6.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 10886317BACKGROUND
  • 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.

    PMID: 17178824BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 26957769BACKGROUND
  • 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.

    PMID: 35962597BACKGROUND
  • 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.

    PMID: 26180145BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Aruba Saeed, phd*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2024

First Posted

April 23, 2024

Study Start

April 1, 2024

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

April 23, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations