To find the effects of Chest Expansion exercises on pulmonary function, chest expansion, trunk control ability and quality of life among stroke patients.
Design
Two parallel groups, double blinded, randomized controlled trial with pre and post assessment
Settings and conduct
Physiotherapy department of Jinnah Memorial Trust Hospital Gujranwala
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
• Patients between age group of 40-55 years
• Both genders
• Chronic stroke from at least last 6 months-2 years of both forms (ischemic and hemorrhage).
• Hemiplegic patients caused by stroke
• Patients are able to sit independently
• Patients who are able to walk independently with or without walking aid
Exclusion Criteria:
• Patients with any pulmonary disease before onset of stroke
• Patients with thoracic deformity or rib fracture
• Patients who received respiratory rehabilitation for stroke
• Patients with any neurological disorder other than stroke
Intervention groups
Conventional neurorehabilitation program along with Chest expansion exercises
Main outcome variables
Pulmonary function test by using Diagnostic Spirometry, Assessment of quality of life using SS-QOL (Stroke Specific Quality Of Life) questionnaire, Trunk Impairment Scale used to assess trunk control (TIS), Measurement of Chest Expansion using measuring tape.
General information
Reason for update
Acronym
Effects Of Chest Expansion Exercises Among Stroke Patients
IRCT registration information
IRCT registration number:IRCT20191117045462N16
Registration date:2024-07-20, 1403/04/30
Registration timing:prospective
Last update:2024-07-20, 1403/04/30
Update count:0
Registration date
2024-07-20, 1403/04/30
Registrant information
Name
Wajeeha Zia
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 42 35126110
Email address
wajeeha_z@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-15, 1403/05/25
Expected recruitment end date
2024-12-15, 1403/09/25
Actual recruitment start date
2024-08-15, 1403/05/25
Actual recruitment end date
2024-12-15, 1403/09/25
Trial completion date
2025-02-15, 1403/11/27
Scientific title
Effects Of Chest Expansion Exercises On Pulmonary Function, Chest Expansion, Trunk Control Ability And Quality Of Life Among Stroke Patients
Public title
Effects Of Chest Expansion Exercises On Pulmonary Function, Chest Expansion, Trunk Control Ability And Quality Of Life Among Stroke Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between age group of 40-55 years
Both genders
Chronic stroke from at least last 6 months-2 years of both forms (ischemic and hemorrhage)
Hemiplegic patients caused by stroke.
Patients are able to sit independently
Patients who are able to walk independently with or without walking aid
Exclusion criteria:
Patients with any pulmonary disease before onset of stroke.
Patients with thoracic deformity or rib fracture.
Patients who received respiratory rehabilitation for stroke.
Patients with any neurological disorder other than stroke
Age
From 40 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
42
Actual sample size reached:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Taking into account the above mentioned inclusion and exclusion criteria, patients will be recruited in the study through convenient sampling technique and then will be randomly assigned to each group through Random Sampling sealed opaque enveloped. Labeled as 1 Group A and 2 for Group B
Blinding (investigator's opinion)
Double blinded
Blinding description
Both patient and assessor physiotherapist will be blinded. Although the consent form will be taken from the patient. But the patient will not be aware of the study. Accessor physiotherapist will be involved in the study. He or She must have 2- or 3-year experience in relevant domain. He will access the patient by study defined outcome measure tools before the start and at the end of study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Riphah college of rehabilitation & Allied Health Sciences
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore
City
Lahore
Postal code
54660
Approval date
2024-07-04, 1403/04/14
Ethics committee reference number
RCS&AHS/REC/MS-CPPT
Health conditions studied
1
Description of health condition studied
Stroke patients
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome
Primary outcomes
1
Description
Pulmonary Function
Timepoint
Pre and Post Treatment
Method of measurement
Diagnostic spirometer
2
Description
Chest Expansion
Timepoint
Pre and post Treatment
Method of measurement
Measuring Tape
3
Description
Trunk control ability
Timepoint
Pre and post Treatment
Method of measurement
Trunk Impairment Scale (TIS)
4
Description
Quality Of Life
Timepoint
Pre and post Treatment
Method of measurement
Stroke Specific Quality Of Life (SS-QOL)
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Conventional neurorehabilitation program
Category
Rehabilitation
2
Description
Intervention group: Conventional neurorehabilitation program along with Chest expansion exercises
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Jinnah Memorial Trust Hospital
Full name of responsible person
Noor ul Zuha
Street address
287/A, Block A Model Town, Gujranwala, Punjab
City
Gujranwala
Postal code
52200
Phone
+92 55 3253467
Email
noorulzuha123@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Wajeeha Zia
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore
City
Lahore
Postal code
54660
Phone
+92 42 111 747 424
Email
Wajeeha.zia@riphah.edu.pk
Grant name
Nill
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Riphah International University
Proportion provided by this source
15
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Expert Consultant Clinic
Full name of responsible person
Muhammad Umer Arshad
Position
HOD
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
627, Khayaban e Jinnah, Iqbal Avenue Cooperative Housing Society-Phase 1, Airline Society
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 111 747 424
Email
omerkhushi0101@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Wajeeha Zia
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore
City
Lahore
Province
Punjab
Postal code
54660
Phone
+92 42 111 747 424
Email
Wajeeha.zia@riphah.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Noor ul Zuha
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore
City
Lahore
Province
Punjab
Postal code
54660
Phone
+92 42 111 747 424
Email
noorulzuha123@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available