Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202505839208183 Date of Registration: 21/05/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Adding Exercises Of Balance To The Physical Therapy Program For Post-Mastectomy Upper Limb Lymphedema: A Randomized Controlled Study
Official scientific title Adding Exercises Of Balance To The Physical Therapy Program For Post-Mastectomy Upper Limb Lymphedma: A Randomized Controlled Study
Brief summary describing the background and objectives of the trial Breast removal in breast cancer patients causes postural muscle tone and postural biomechanics changes due to weakness of upper limb and shoulder girdle muscles, pain, scar tissue, contracture, and lymphedema. Upper limb lymphedema is the most common complication secondary to mastectomy surgery and cancer treatment (chemotherapy and radiotherapy) with a prevalence of 6- 35% developing it after breast cancer treatment. Lymphedema is the chronic accumulation of protein-rich fluid after lymphatic vessel obstruction or damage due to removing lymph nodes or radiotherapy.Postural control and balance are important factors in the daily life activity and functions. balance is regulation of body's center of gravity in response to change of body direction and surface condition. Center of gravity (COG) deviation from its location as a cause of any body part leaning on the supporting surface can be defined as postural imbalance (postural sway). The aim of the exist study was to assess the effect of balance training on the balance in the postmastectomy lymphedema patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/03/2025
Actual trial start date 05/03/2025
Anticipated date of last follow up 15/05/2025
Actual Last follow-up date 10/02/2026
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation Sequence/Code was not concealed Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group balance exercse and traditional physical therapy 3 session per week for 6 weeks 1- apply postural stability trianing on biodex balance system 2- balance exercises on half ball and polymetric exercise 3- pneumatic compression 4- manual lymphatic driange 5- active pumping muscle exercises 30
Control Group traditional physical therapy 3 session per week for 6 weeks 1- pneumatic compression 2- manual lymphatic driange 3- active pumping muscle exercises 30 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-female 2-post mastectomy with axillary lymph nodes dissection from 5-21 years 3- lymph edema appearance 1-5 ago 1-metastasis, 2- wounds or ulcers 3- cellulitis Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 33 Year(s) 55 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/01/2025 research ethical commitee of physical therapy
Ethics Committee Address
Street address City Postal code Country
south valley univesity, Qena, Egypt Qena 83523 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postural control test on balance biodex system before and post trial
Secondary Outcome upper limb volume measurement by circumference measurment before and after treament
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physcal therapy south valley university Qena-safage stree km6 Qena 83523 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
sourth valley university sourth valley university Qena 83523 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mahmoud Elshazly south valley university Qena 83523 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Elshazly mahmoud.elshazly311@svu.edu.eg +201019833732 south valley university
City Postal code Country Position/Affiliation
Qena 83523 Egypt assisstant professor of physical therapy for surgery faculty of physical south valley university
Role Name Email Phone Street address
Public Enquiries sallam Ali sallampt@svu.edu.eg +201000693632 south valley university
City Postal code Country Position/Affiliation
Qena 83523 Egypt lecturere of physical therapy faculty of physical therapy south valley university
Role Name Email Phone Street address
Scientific Enquiries Ahmed Shawky Dr.shawky_2011@cu.edu.eg +201068443366 south valley university
City Postal code Country Position/Affiliation
Qena 83523 Egypt assisstant profesor of physical therapy cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in lymphedema management. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data. Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 12/05/2025 Editor notcie ADDING EXERCISES OF BALANCE TO THE PHYSICAL THERAPY PROGRAM FOR POST-MASTECTOMY UPPER LIMB LYMPHEDEMA Adding Exercises Of Balance To The Physical Therapy Program For Post-Mastectomy Upper Limb Lymphedma
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 10/03/2026 because the final revision before publication Adding Exercises Of Balance To The Physical Therapy Program For Post-Mastectomy Upper Limb Lymphedma Adding Exercises Of Balance To The Physical Therapy Program For Post-Mastectomy Upper Limb Lymphedema: A Randomized Controlled Study
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 12/05/2025 editor notice ADDING EXERCISES OF BALANCE TO THE PHYSICAL THERAPY PROGRAM FOR POST-MASTECTOMY UPPER LIMB LYMPHEDEMA Adding Exercises Of Balance To The Physical Therapy Program For Post-Mastectomy Upper Limb Lymphedma
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 10/03/2026 because the final revision before publication Adding Exercises Of Balance To The Physical Therapy Program For Post-Mastectomy Upper Limb Lymphedma Adding Exercises Of Balance To The Physical Therapy Program For Post-Mastectomy Upper Limb Lymphedma: A Randomized Controlled Study
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 10/03/2026 this is the dte of the end of trial 10 Feb 2026
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 11/05/2026 updated according to reviewer comment Active, not recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 12/05/2025 reviwer notice female, post mastectomy with axillary lymph nodes dissection from 5-21 years, lymph edema appearance 1-5 ago 1-female 2-post mastectomy with axillary lymph nodes dissection from 5-21 years 3- lymph edema appearance 1-5 ago
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 12/05/2025 reviwer notice no metastasis, no wounds or ulcers, no cellulitis 1-metastasis, 2- wounds or ulcers 3- cellulitis
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 27/06/2026 reviwer comment TRUE, research ethical commitee of physical therapy , south valley univesity, Qena, Egypt , Qena, 83523, Egypt, , 01 May 2025, +201017092125, svupt.ethicalcommittee@pt.svu.eg, 33625_30762_4737.pdf TRUE, research ethical commitee of physical therapy , south valley univesity, Qena, Egypt , Qena, 83523, Egypt, , 02 Jan 2025, +201017092125, svupt.ethicalcommittee@pt.svu.eg, 33625_30762_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 05/05/2025 according to reviewer notice self , sourth valley university , Qena, 83523, Egypt, Self Funded, PRINCIPLE INVESTIGATOR, sourth valley university , Qena, 83523, Egypt, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 12/05/2025 according to reviewer notice PRINCIPLE INVESTIGATOR, sourth valley university , Qena, 83523, Egypt, Self Funded, sourth valley university , sourth valley university , Qena, 83523, Egypt, University,
Section Name Field Name Date Reason Old Value Updated Value
Sponsors Sponsors List 11/05/2026 according toe reviewer comment self, south valley university , Qena , 83523, Egypt, Primary Sponsor, University, principle investigator, south valley university , Qena , 83523, Egypt, Primary Sponsor, University,
Section Name Field Name Date Reason Old Value Updated Value
Sponsors Sponsors List 27/06/2026 according toe reviewer comment principle investigator, south valley university , Qena , 83523, Egypt, Primary Sponsor, University, Mahmoud Elshazly, south valley university , Qena , 83523, Egypt, Primary Sponsor, Individual,
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 05/05/2025 according to reviwer notice abstract and result summary result
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 18/05/2025 reviwer comments summary result Data obtained through this study may be provided to qualified researchers with academic interest in lymphedema management. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 05/05/2025 according to reviwer notice Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Data requests can be submitted starting 6months after article publication and the data will be made accessible for up to 12 months.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 18/05/2025 reviwer comments Data requests can be submitted starting 6months after article publication and the data will be made accessible for up to 12 months. Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 18/05/2025 reviwer comments oncology physical therapist Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).