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Stroke, AcuteNCT06379854

Trunk Rotation And Lateral Flexion Exercises In Stroke Patients

A study testing chest physiotherapy and trunk rotation exercises,deep diaphragmatic also chest physiotherapy in people with Stroke, Acute, run by Riphah International University at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages Up to 50 years
Conditions the study is for
Stroke, Acute
What is being tested?
chest physiotherapy and trunk rotation exercises,deep diaphragmatic also chest physiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 sitePakistan
Study dates
1 Apr 2024to Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 50 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Can perform exercises with Active Assistance
  • Patients who easily perform exercises
  • Patients who response to commands

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Imran amjad, phd contact

03324390125

imran.amjad@riphah.edu.pk

Pakistan1 site, 1 recruiting
  • Shahida Khaliq Health Centre

    Islamabad, 44080

    Sara Jahan, MSPT, +923415182331, saira.jahan@riphah.edu.pk

    Recruiting

Other trials in Pakistan

About this study

Official title: Effects Of Trunk Rotation And Lateral Flexion Exercises On Peak Cough Flow And Chest Expansion In Stroke Patients

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.

Read the detailed 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.

Conditions
Stroke, Acute
Being tested
chest physiotherapy, trunk rotation exercises,deep diaphragmatic also chest physiotherapy
Keywords
stroke, TRROM trunk rotation range of motion, TLFROM trunk lateral rotation range of motion, CPF cough peak flow meter
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • chest physiotherapyOther

    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 physiotherapyOther

    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

Study groups in NCT06379854
Study groupRoleWhat they receive
chest physiotherapyExperimentalwe take 2 groups in one group only chest physiotherapy introduce
Receives: Other: chest physiotherapy
trunk rotation exercises,deep diaphragmatic also chest physiotherapyActive comparatorBut in 2nd group chest physiotherapy with trunk rotation exercises and deep diaphragmatic breathing exercises alo introduce.
Receives: Other: trunk rotation exercises,deep diaphragmatic also chest physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4th week

  2. 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.

    Measured: 4th week

  3. 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)

    Measured: 4th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2024
  2. Study start1 Apr 2024
  3. Primary completionJun 2024 (estimated)
  4. Study completionJun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06379854
Sponsor's protocol ID
RCRAHS-ISB/REC/MS-PT/01814
Status last verified
Apr 2024
First submitted
18 Apr 2024
Last updated
23 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23652265
  • 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.

    PubMed 27708464
  • 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.

    PubMed 34785599
  • 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.

    PubMed 33190399
  • 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.

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

    PubMed 25884860
  • 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.

    PubMed 16088617
  • 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.

    PubMed 10886317
  • 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.

    PubMed 17178824
  • 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.

  • 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.

    PubMed 26957769

Questions about this trial

What is this clinical trial studying?

A study testing chest physiotherapy and trunk rotation exercises,deep diaphragmatic also chest physiotherapy in people with Stroke, Acute, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Imran amjad, phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trunk Impairment Scale: (time frame: 4th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06379854, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.

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