Kinetic ControlNCT07023913
Effect of Kinetic Control Exercise on Shoulder Dysfunction Post Mastectomy
A study testing traditional treatment in people with Kinetic Control and Dysfunction, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to evaluate the effect of kinetic control exercises on shoulder dysfunction in post-mastectomy. Read more about this study
- Who is it for?
- Ages 40 to 50 years, women only
- Conditions the study is for
- Kinetic Control, Dysfunction, Shoulder
- What is being tested?
- traditional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2025to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The subject selection will be according to the following criteria:
- Age from 40 to 50 years.
- All patients have no diabetes or blood problems.
- All patients enrolled to the study will have their informed consent.
Who cannot join
- The potential participants will be excluded if they meet one of the following criteria:
- Age less than 40 or more 50 years.
- Diabetes mellitus.
- Subjects with lymphedema
- Subjects suffering from active malignant tumors.
- Subjects treated with skin graft.
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- Subjects with Mental illness.
- Subjects with skin diseases
- Subjects with any previous cause for shoulder dysfunction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
learning hospitals Al Kaser Al Ayni hospital
Cairo
Alaa Tarek Mostafa Elnawawy, physical therapist, +201005730916, alaatarekmostafa@gmail.com
About this study
The purpose of this study is to evaluate the effect of kinetic control exercises on shoulder dysfunction in post-mastectomy.
Read the detailed description
This study holds significant importance for clinical practice, patient care, and research.
- Clinical Practice: It provides a potential framework for physical therapists to design targeted and effective interventions for shoulder dysfunction in post-mastectomy patients.
- Patient Care: Improved rehabilitation outcomes can enhance patients' physical functionality, independence, and overall quality of life, addressing a critical gap in post-operative recovery.
- Research Advancement: By contributing to the limited body of literature on kinetic control in this context, the study can stimulate further research and innovation in rehabilitative care for breast cancer survivors.
- Conditions
- Kinetic Control, Dysfunction, Shoulder, Mastectomy
- Being tested
- kinetic Control exercises, traditional treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinetic Control exercisesOther
Kinetic Control exercises consist of 45-minute sessions, with 3 sessions per week for 8 weeks. The framework for testing and rehabilitation includes initial assessment, rehabilitation before failure, and retesting the same position. Biofeedback measures scapular retraction, and biofeedback pressure training assesses and improves scapular stabilizer control by monitoring pressure changes during specific movements.
traditional treatmentOther
traditional therapy inform of stretching and strengthening exercise as shoulder roll, arm circle, wall climb, back climb and hand behind neck. Patients will receive 3 sessions per week for 8 weeks, the time of session is 45 - 60 min according to patient ability
| Study group | Role | What they receive |
|---|---|---|
| Kinetic Control Exercise | Experimental | This group includes 30 patients who had mastectomy and will receive Kinetic control exercise inform of activation local and general Stabilizer, mobilizer), and traditional exercise. Patients will receive 3 sessions per week for 8 weeks. Receives: Other: kinetic Control exercises; Other: traditional treatment |
| traditional therapy | Active comparator | This group includes 30 patients who have undergone mastectomy and will receive traditional therapy inform of stretching and strengthening exercise as shoulder roll, arm circle, wall climb, back climb and hand behind neck. Patients will receive 3 sessions per week for 8 weeks. Receives: Other: traditional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of change of range of motion
Patients will be seated with their affected limb relaxed, and their goniometer will measure their resting position and active range. They will measure shoulder abduction and flexion, which are rarely affected by day-to-day activities, and external shoulder rotation.
Measured: at baseline and after 8 weeks
Secondary outcomes (2)
assessment of ability to maintain controlled shoulder movements while stabilizing the scapular and shoulder
it is a series of tests to assess kinetic control, including shoulder flexion, scapular retraction, and isometric holds. The tests focus on maintaining consistent pressure, detecting compensatory patterns, and evaluating fatigue. The tests also include a scapular stabilization test and a shoulder flexion stability test, which measure muscle activation patterns and stability.
Measured: at baseline and after 8 weeks
assessment of ability to maintain controlled shoulder movements while stabilizing the scapular and shoulder
The tests also include a scapular stabilization test and a shoulder flexion stability test, which measure muscle activation patterns and stability.
Measured: at baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start15 Jun 2025 (estimated)
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kinetic ControlStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Tarek Mostafa ElNawawy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023913
- Sponsor's protocol ID
- Alaa-005696
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinetic Control Exercise on Shoulder Dysfunction Post Mastectomy
- ClinicalTrials.gov ID
- NCT07023913
- Acronym / sponsor ID
- Alaa-005696
- Conditions
- Kinetic Control, Dysfunction, Shoulder, Mastectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of kinetic control exercises on shoulder dysfunction in post-mastectomy.
Detailed description
This study holds significant importance for clinical practice, patient care, and research.
- Clinical Practice: It provides a potential framework for physical therapists to design targeted and effective interventions for shoulder dysfunction in post-mastectomy patients.
- Patient Care: Improved rehabilitation outcomes can enhance patients' physical functionality, independence, and overall quality of life, addressing a critical gap in post-operative recovery.
- Research Advancement: By contributing to the limited body of literature on kinetic control in this context, the study can stimulate further research and innovation in rehabilitative care for breast cancer survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinetic Control Exercise | Experimental | Other: kinetic Control exercises, Other: traditional treatmentThis group includes 30 patients who had mastectomy and will receive Kinetic control exercise inform of activation local and general Stabilizer, mobilizer), and traditional exercise. Patients will receive 3 sessions per week for 8 weeks. |
| traditional therapy | Active comparator | Other: traditional treatmentThis group includes 30 patients who have undergone mastectomy and will receive traditional therapy inform of stretching and strengthening exercise as shoulder roll, arm circle, wall climb, back climb and hand behind neck. Patients will receive 3 sessions per week for 8 weeks. |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age from 40 to 50 years.
- All patients have no diabetes or blood problems.
- All patients enrolled to the study will have their informed consent.
Key exclusion criteria (9 listed)
- Age less than 40 or more 50 years.
- Diabetes mellitus.
- Subjects with lymphedema
- Subjects suffering from active malignant tumors.
- Subjects treated with skin graft.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| kinetic Control exercisesKinetic Control exercises consist of 45-minute sessions, with 3 sessions per week for 8 weeks. The framework for testing and rehabilitation includes initial assessment, rehabilitation before failure, and retesting the same position. Biofeedback measures scapular retraction, and biofeedback pressure training assesses and improves scapular stabilizer control by monitoring pressure changes during specific movements. | Other | Kinetic Control Exercise |
| traditional treatmenttraditional therapy inform of stretching and strengthening exercise as shoulder roll, arm circle, wall climb, back climb and hand behind neck. Patients will receive 3 sessions per week for 8 weeks, the time of session is 45 - 60 min according to patient ability | Other | Kinetic Control Exercise, traditional therapy |
Primary outcome
assessment of change of range of motion
Time frame: at baseline and after 8 weeks
Patients will be seated with their affected limb relaxed, and their goniometer will measure their resting position and active range. They will measure shoulder abduction and flexion, which are rarely affected by day-to-day activities, and external shoulder rotation.
2 secondary outcomes
assessment of ability to maintain controlled shoulder movements while stabilizing the scapular and shoulder
Time frame: at baseline and after 8 weeks
assessment of ability to maintain controlled shoulder movements while stabilizing the scapular and shoulder
Time frame: at baseline and after 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traditional treatment in people with Kinetic Control and Dysfunction, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 9 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: opening soon, as of the sponsor's last update on 17 Jun 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alaa Tarek Mostafa Elnawawy, physical therapist (+201005730916, alaatarekmostafa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of change of range of motion (time frame: at baseline and after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2025.