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General information
2023-11-05, 1402/08/14
2023-12-01, 1402/09/10
2023-1112-0501 00:00:00
2023-12-30, 1402/10/09
2024-01-20, 1402/10/30
20232024-1201-3020 00:00:00
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To update important information
To update important information
Protocol summary
Study aim
To compare the effects of stretching and PNF Hold Relax technique for shoulder mobility in post mastectomy patients
Design
Randomized clinical trial
Settings and conduct
Government and Private hospitals of Faisalabad
Participants/Inclusion and exclusion criteria
Inclusion criteria
1. Age 30-60y
2. Females
3. Post mastectomy patients
Exclusion criteria
1. Males
2. Females with chronic illness and traumas
Intervention groups
Group A will receive stretching
Group B will receive hold relax technique
Main outcome variables
Shoulder disability
General information
Reason for update
To update important information
Acronym
IRCT registration information
IRCT registration number:IRCT20220930056062N3
Registration date:2023-11-29, 1402/09/08
Registration timing:prospective
Last update:2023-12-02, 1402/09/11
Update count:2
Registration date
2023-11-29, 1402/09/08
Registrant information
Name
Kaiynat Shafique
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 334 6925051
Email address
kaiynatshafique@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-01, 1402/09/10
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effects of stretching and PNF hold relax technique for shoulder mobility in post mastectomy patient – A Randomized Clinical Trial
Public title
Comparative effects of stretching and PNF hold relax technique for shoulder mobility in post mastectomy patient – A Randomized Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Females
Age 30 to 60 years
Post Mastectomy patients
Exclusion criteria:
Age above 60 years or below 30
Males
Chronic illness and traumas
Age
From 30 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization through lottery method
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will be blind in this clinical trial
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Government College University Faisalabad
Street address
Gulberg Faisalabad
City
Faisalabad
Postal code
38000
Approval date
2023-11-03, 1402/08/12
Ethics committee reference number
20759
Health conditions studied
1
Description of health condition studied
Carcinoma in situ of breast
ICD-10 code
D05
ICD-10 code description
Carcinoma in situ of breast
Primary outcomes
1
Description
Shoulder disability
Timepoint
Shoulder disability
Method of measurement
DAS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group A received stretching for 3 weeks, 10 repetition per session with 35 minutes of treatment time
Category
Rehabilitation
2
Description
Intervention group: Group B received PNF hold and relax technique for 3 weeks, 3 repetition per session with 35 minutes of treatment time.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Allied Hospital faisalabad
Full name of responsible person
Rafia Imtiaz
Street address
Faisalabad
City
Faisalaabd
Postal code
38000
Phone
+92 41 9210092
Email
rafiaimtiaz@gcuf.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Government College University Faisalabad
Full name of responsible person
Rafia Imtiaz
Street address
Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 41 9210023
Email
rafiaimtiaz@gcuf.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
No funding was received
Proportion provided by this source
1
Public or private sector
Public
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
Government College University Faisalabd
Full name of responsible person
Rafia Imtiaz
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 9200876
Email
rafiaimtiaz@gcuf.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Government College University Faisalabad
Full name of responsible person
Rafia Imtiaz
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 9200066
Email
rafiaimtiaz@gcuf.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Government College University Faisalabad
Full name of responsible person
Rafia Imtiaz
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 9200886
Fax
Email
rafiaimtiaz@gcuf.edu.pk
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
Privacy concerns
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
Yes - There is 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
Title and more details about the data/document
COMPARATIVE EFFECTS OF STRETCHING AND PNF HOLD RELAX TECHNIQUE FOR SHOULDER MOBILITY IN POST MASTECTOMY PATIENT – A RANDOMIZED CLINICAL TRIAL
When the data will become available and for how long
Data from this trial will not be made publicly available. However, it may be accessible upon request. For inquiries regarding data access, please contact rafiaimtiaz@gcuf.edu.pk.
To whom data/document is available
Data from this trial will not be made publicly available. However, it may be accessible upon request. For inquiries regarding data access, please contact rafiaimtiaz@gcuf.edu.pk.
Under which criteria data/document could be used
Data from this trial will not be made publicly available. However, it may be accessible upon request. For inquiries regarding data access, please contact rafiaimtiaz@gcuf.edu.pk.
From where data/document is obtainable
Data from this trial will not be made publicly available. However, it may be accessible upon request. For inquiries regarding data access, please contact rafiaimtiaz@gcuf.edu.pk.
What processes are involved for a request to access data/document
Data from this trial will not be made publicly available. However, it may be accessible upon request. For inquiries regarding data access, please contact rafiaimtiaz@gcuf.edu.pk.