Protocol summary
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Study aim
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To compare the effects of stretching and PNF Hold Relax technique for shoulder mobility in post mastectomy patients
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Design
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Randomized clinical trial
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Settings and conduct
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Government and Private hospitals of Faisalabad
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Participants/Inclusion and exclusion criteria
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Inclusion criteria
1. Age 30-60y
2. Females
3. Post mastectomy patients
Exclusion criteria
1. Males
2. Females with chronic illness and traumas
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Intervention groups
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Group A will receive stretching
Group B will receive hold relax technique
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Main outcome variables
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Shoulder disability
General information
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Reason for update
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To update important information
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220930056062N3
Registration date:
2023-11-29, 1402/09/08
Registration timing:
prospective
Last update:
2025-04-14, 1404/01/25
Update count:
2
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Registration date
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2023-11-29, 1402/09/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-12-01, 1402/09/10
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Expected recruitment end date
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2024-01-20, 1402/10/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparative effects of stretching and PNF hold relax technique for shoulder mobility in post mastectomy patient – A Randomized Clinical Trial
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Public title
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Comparative effects of stretching and PNF hold relax technique for shoulder mobility in post mastectomy patient – A Randomized Clinical Trial
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 30 years old to 60 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization through lottery method
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Patients will be blind in this clinical trial
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Placebo
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Not used
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Assignment
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Other
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-11-03, 1402/08/12
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Ethics committee reference number
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20759
Health conditions studied
1
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Description of health condition studied
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Carcinoma in situ of breast
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ICD-10 code
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D05
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ICD-10 code description
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Carcinoma in situ of breast
Primary outcomes
1
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Description
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Shoulder disability
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Timepoint
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Shoulder disability
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Method of measurement
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DAS questionnaire
Intervention groups
1
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Description
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Intervention group: Group A received stretching for 3 weeks, 10 repetition per session with 35 minutes of treatment time
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Category
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Rehabilitation
2
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Description
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Intervention group: Group B received PNF hold and relax technique for 3 weeks, 3 repetition per session with 35 minutes of treatment time.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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No funding was received
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Proportion provided by this source
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1
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Privacy concerns
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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COMPARATIVE EFFECTS OF STRETCHING AND PNF HOLD RELAX TECHNIQUE FOR SHOULDER MOBILITY IN POST MASTECTOMY PATIENT – A RANDOMIZED CLINICAL TRIAL
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When the data will become available and for how long
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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.
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To whom data/document is available
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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.
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Under which criteria data/document could be used
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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.
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From where data/document is obtainable
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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.
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What processes are involved for a request to access data/document
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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.
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Comments
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