Pilates ExerciseNCT07297706
Pilates Exercises Versus Mirror Therapy on Shoulder Dysfunction Post Neck Dissection Surgeries
A study testing Pilates exercises, Mirror therapy and Traditional physical therapy in people with Pilates Exercise and Mirror Therapy, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to compare the therapeutic effects of pilates exercises and mirror therapy on shoulder dysfunction post-neck dissection surgeries. Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Pilates Exercise, Mirror Therapy, Shoulder Pain
- What is being tested?
- Pilates exercises, Mirror therapy and Traditional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 13 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient's age ranged between 35-55 years.
- Both genders will participate in the study.
- All patients suffering from shoulder dysfunction post-unilateral neck dissection surgeries ( modified radical and selective neck dissection surgeries).
- All patients will have shoulder pain, limited ROM (flexion, abduction, external rotation) and limited shoulder function.
- All patients will begin the treatment program 1-3 months after neck dissection surgeries.
- All patients enrolled in the study will have their informed consent.
Who cannot join
- Subjects suffering from active malignant tumors.
- Subjects with rotator cuff tears or other shoulder ligaments injuries.
- A history of neck or ipsilateral shoulder injuries, pain in the last 6-month prior neck dissection surgeries.
- Adhesive capsulitis secondary to diabetes mellitus or fractures.
- Recurrent shoulder dislocation.
- Recent fractures or surgeries in the shoulder.
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- Neurological disorder
- The presence of residual local regional cancer or distant metastases to other regions.
- Comorbid medical illness or psychiatric illness and visual disturbance that would prevent completion of treatment.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the therapeutic effects of pilates exercises and mirror therapy on shoulder dysfunction post-neck dissection surgeries.
Read the detailed description
Shoulder morbidity is a significant concern for patients undergoing neck dissection in head and neck cancer treatment, with more extensive surgeries correlated with higher postoperative shoulder issues. Preservation of the spinal accessory nerve during modified radical neck dissection reduces shoulder dysfunction. Shoulder pain often results from trapezius deficits due to nerve injury, leading to symptoms like shoulder droop and loss of function. Current management of oral and oropharyngeal carcinoma focuses on selective procedures that maintain nonlymphatic structures in the neck, as extended dissections are linked to increased shoulder dysfunction. This study aims to compare the effectiveness of pilates exercises and mirror therapy in improving shoulder dysfunction after neck dissection surgeries.
- Conditions
- Pilates Exercise, Mirror Therapy, Shoulder Pain, Dissection
- Being tested
- Pilates exercises, Mirror therapy, Traditional physical therapy
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates exercisesOther
Pilates exercise aids in recovery post-breast cancer surgery by improving daily living activities, shoulder function, and quality of life. It emphasizes principles such as centralization, concentration, control, precision, flow, and breathing, enhancing muscle strength and flexibility. Additionally, mild stretching exercises contribute to maintaining and increasing range of motion, and Pilates can be tailored to individual patient needs and abilities.
Mirror therapyOther
Mirror therapy has been shown to enhance shoulder function in patients with shoulder problems immediately after the intervention. Three-minute of Mirror therapy improved forward flexion by 14.5° in patients with shoulder pain and limited shoulder range of motion
Traditional physical therapyOther
including (ROM exercises, pendulum exercises, shoulder wheel exercises, stretching, and strengthening exercises for shoulder muscles)
| Study group | Role | What they receive |
|---|---|---|
| Pilates exercises | Experimental | This group will include 26 patients suffering from shoulder post-neck dissection surgeries (Modified radical and selective NDS). They will receive the pilate exercises for 40 min/session, 3 sessions/ week for 8 weeks, in addition to the traditional physical therapy program (ROM exercises, pendulum exercises, shoulder wheel exercises, stretching, and strengthening exercises for shoulder muscles) Receives: Other: Pilates exercises; Other: Traditional physical therapy |
| Mirror therapy | Active comparator | This group will include 26 patients suffering from shoulder dysfunction post neck dissection surgeries (modified radical, and selective NDS), they will receive Mirror therapy for 40 min/session, 3 sessions/ week for 8 weeks in addition to the traditional physical therapy program (ROM exercises, pendulum exercises, shoulder wheel exercises, stretching, and strengthening exercises for shoulder muscles) Receives: Other: Mirror therapy; Other: Traditional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of pain intensity
Participants in both groups will mark a number on a 10-cm line (0 to 10) to indicate their pain level, with 10 being the most painful. Pain ratings during exercise was assessed at baseline (pre-treatment) and after 8 weeks of treatment (post-treatment) using visual analogue numeric pain scale
Measured: at baseline and after 8 weeks
Secondary outcomes (4)
assessment of shoulder flexion range of motion
Shoulder range of motion (ROM) was assessed using a digital goniometer with participants seated. They will remove clothing from the affected shoulder and perform maximal active ROM during assessments. For shoulder flexion, the goniometer's axis will be placed over the acromion process, the stationary arm aligned with the midaxillary line, and the moving arm positioned along the central line of the upper arm.
Measured: at baseline and after 8 weeks
Assessment of shoulder external rotation range of motion
Shoulder range of motion (ROM) was assessed using a digital goniometer with participants seated. They will remove clothing from the affected shoulder and perform maximal active ROM during assessments. External rotation is assessed when the upper limb is in a 90° abducted position. The goniometer's axis is positioned at the olecranon process, the stationary arm is aligned parallel to the ground, and the moving arm is adjusted to the ulna.
Measured: at baseline and after 8 weeks
Assessment of the shoulder abduction range of motion
Shoulder range of motion (ROM) was assessed using a digital goniometer with participants seated. They will remove clothing from the affected shoulder and perform maximal active ROM during assessments. Shoulder abduction measurement involves positioning the goniometer's axis over the acromion process, aligning the stationary arm parallel to the spine, and setting the moving arm along the central line of the upper arm, following the protocol recommended by Lee and Kim
Measured: at baseline and after 8 weeks
assessment of upper limb function
The study assessed upper limb function using the Arabic version of the Quick Disabilities of the Arm, Shoulder and Hand-9 scale before and after 8 weeks of treatment. The scale consists of 9 items rated on a 4-point Likert scale, where higher scores indicate increased disability and reduced function. A scaled score is computed from the total scores (0-100) using a specific formula, accommodating missing items by averaging remaining scores. Progress was measured by calculating the percent improvement in Quick Disabilities of the Arm, Shoulder and Hand-9 scores post-treatment.
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 posted22 Dec 2025
- Study start1 Apr 2025
- Primary completion13 Sep 2025
- Study completion13 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilates ExerciseStudies 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmen gamal Elrakhawi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297706
- Sponsor's protocol ID
- Yasmen-Msc
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 22 Dec 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 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilates Exercises Versus Mirror Therapy on Shoulder Dysfunction Post Neck Dissection Surgeries
- ClinicalTrials.gov ID
- NCT07297706
- Acronym / sponsor ID
- Yasmen-Msc
- Conditions
- Pilates Exercise, Mirror Therapy, Shoulder Pain, Dissection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 13 Sep 2025 (actual)
- Study completion
- 13 Oct 2025 (actual)
- First posted
- 22 Dec 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 compare the therapeutic effects of pilates exercises and mirror therapy on shoulder dysfunction post-neck dissection surgeries.
Detailed description
Shoulder morbidity is a significant concern for patients undergoing neck dissection in head and neck cancer treatment, with more extensive surgeries correlated with higher postoperative shoulder issues. Preservation of the spinal accessory nerve during modified radical neck dissection reduces shoulder dysfunction. Shoulder pain often results from trapezius deficits due to nerve injury, leading to symptoms like shoulder droop and loss of function. Current management of oral and oropharyngeal carcinoma focuses on selective procedures that maintain nonlymphatic structures in the neck, as extended dissections are linked to increased shoulder dysfunction. This study aims to compare the effectiveness of pilates exercises and mirror therapy in improving shoulder dysfunction after neck dissection surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates exercises | Experimental | Other: Pilates exercises, Other: Traditional physical therapyThis group will include 26 patients suffering from shoulder post-neck dissection surgeries (Modified radical and selective NDS). They will receive the pilate exercises for 40 min/session, 3 sessions/ week for 8 weeks, in addition to the traditional physical therapy program (ROM exercises, pendulum exercises, shoulder wheel exercises, stretching, and strengthening exercises for shoulder muscles) |
| Mirror therapy | Active comparator | Other: Mirror therapy, Other: Traditional physical therapyThis group will include 26 patients suffering from shoulder dysfunction post neck dissection surgeries (modified radical, and selective NDS), they will receive Mirror therapy for 40 min/session, 3 sessions/ week for 8 weeks in addition to the traditional physical therapy program (ROM exercises, pendulum exercises, shoulder wheel exercises, stretching, and strengthening exercises for shoulder muscles) |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient's age ranged between 35-55 years.
- Both genders will participate in the study.
- All patients suffering from shoulder dysfunction post-unilateral neck dissection surgeries ( modified radical and selective neck dissection surgeries).
- All patients will have shoulder pain, limited ROM (flexion, abduction, external rotation) and limited shoulder function.
- All patients will begin the treatment program 1-3 months after neck dissection surgeries.
Key exclusion criteria (9 listed)
- Subjects suffering from active malignant tumors.
- Subjects with rotator cuff tears or other shoulder ligaments injuries.
- A history of neck or ipsilateral shoulder injuries, pain in the last 6-month prior neck dissection surgeries.
- Adhesive capsulitis secondary to diabetes mellitus or fractures.
- Recurrent shoulder dislocation.
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 |
|---|---|---|
| Pilates exercisesPilates exercise aids in recovery post-breast cancer surgery by improving daily living activities, shoulder function, and quality of life. It emphasizes principles such as centralization, concentration, control, precision, flow, and breathing, enhancing muscle strength and flexibility. Additionally, mild stretching exercises contribute to maintaining and increasing range of motion, and Pilates can be tailored to individual patient needs and abilities. | Other | Pilates exercises |
| Mirror therapyMirror therapy has been shown to enhance shoulder function in patients with shoulder problems immediately after the intervention. Three-minute of Mirror therapy improved forward flexion by 14.5° in patients with shoulder pain and limited shoulder range of motion | Other | Mirror therapy |
| Traditional physical therapyincluding (ROM exercises, pendulum exercises, shoulder wheel exercises, stretching, and strengthening exercises for shoulder muscles) | Other | Mirror therapy, Pilates exercises |
Primary outcome
assessment of pain intensity
Time frame: at baseline and after 8 weeks
Participants in both groups will mark a number on a 10-cm line (0 to 10) to indicate their pain level, with 10 being the most painful. Pain ratings during exercise was assessed at baseline (pre-treatment) and after 8 weeks of treatment (post-treatment) using visual analogue numeric pain scale
4 secondary outcomes
assessment of shoulder flexion range of motion
Time frame: at baseline and after 8 weeks
Assessment of shoulder external rotation range of motion
Time frame: at baseline and after 8 weeks
Assessment of the shoulder abduction range of motion
Time frame: at baseline and after 8 weeks
assessment of upper limb function
Time frame: at baseline and after 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates exercises, Mirror therapy and Traditional physical therapy in people with Pilates Exercise and Mirror Therapy, 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 6 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: finished, as of the sponsor's last update on 22 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of pain intensity (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 22 Dec 2025.