NCT07103109

Brief Summary

Mastectomy after breast cancer is usually accompanied by shoulder dysfunction which interferes with the daily life activities of the patients and causes physical and psychological impairments. This study aims to assess the impact of strength and stabilization exercise on scapular muscles activation pattern after mastectomy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Aug 2025

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress74%
Aug 2025Aug 2026

First Submitted

Initial submission to the registry

July 29, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

August 5, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2026

Last Updated

April 8, 2026

Status Verified

August 1, 2025

Enrollment Period

10 months

First QC Date

July 29, 2025

Last Update Submit

April 3, 2026

Conditions

Keywords

Proximal stabilization

Outcome Measures

Primary Outcomes (1)

  • EMG Muscle Activation Amplitude

    Surface electromyography (sEMG) will be used to assess the activation patterns of scapular and rotator cuff muscles during functional tasks, such as shoulder flexion, abduction, and external rotation. The sEMG assessment will be conducted using a wireless sEMG system with a sampling rate of 2000 Hz and a bandwidth of 20-500 Hz. Pre-gelled, disposable, self-adhesive Ag/AgCl electrodes will be placed on the muscle belly according to SENIAM guidelines, with an inter-electrode distance of 20 mm. (serratus anterior, upper and lower trapezius, supraspinatus, and infraspinatus) during functional tasks.

    Baseline and 6 weeks

Secondary Outcomes (1)

  • Shoulder pain and disability index (SPADI)

    Baseline and 6 weeks

Study Arms (2)

study group

EXPERIMENTAL
Other: Proximal stabilization exercisesOther: Conventional physical therapy

control

ACTIVE COMPARATOR
Other: Conventional physical therapy

Interventions

Patients will receive Scapular mobilization in five manners, superior glide, inferior glide, up-ward rotation, down-ward rotation, and distraction. Each mobilization will be done ten times. A thirty second break will be given between each set. Also scapular strengthening exercises composed of diagonal two (D2) flexion pattern to augment the upper, middle, lower, and serratus anterior muscles' activity level. To activate upper trapezius muscle, shoulder shrug exercise will be used. To activate serratus anterior muscle, Wall slide exercise will be used. Scapular retraction exercise for rhomboids and middle trapezius activation will be done. Strengthening exercises will be performed using weights were initiated with two sets of ten repetitions, beginning with a weight of 0.5 kg and progressed to 0.75, and1kg, it will be applied 5 days per week for 6 weeks

study group

Patients will receive shoulder joint mobilization, posterior capsular stretching, and ROM exercises in form of Codman/pendulum exercise. To mobilize the shoulder joint, distraction of the glenohumeral joint, posterior glide and caudal glide will be performed to the patients in a supine lying position at a frequency of two to three oscillations/second for one to two minutes. Every direction was repeated three to four times. At the resting position rhythmic oscillations grade I and II will be applied. In posterior capsule stretching each stretch will be repeated ten times for 20 seconds, between each stretching a 30-second break will be given. Pendulum exercise will be demonstrated to the patient at first, then they will performed it in the forward-backward direction, side-to-side direction, and circular pattern, for two to three minutes in each direction, it will be applied 5 days per week for 6 weeks

controlstudy group

Eligibility Criteria

Age35 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPost-mastectomy female subjects
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Post-mastectomy female subjects.
  • Age between 35-55 years.
  • All patients have shoulder dysfunction (three months to four months post mastectomy).

You may not qualify if:

  • Participants who have rheumatoid arthritis.
  • History of trauma or injuries.
  • Neurological deficits (stroke, Parkinsonism).
  • History of surgery on involved shoulder.
  • Diabetic patient.
  • Patients who rejected to participate in the trial, or to summit the formal consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Out patient clinic , faculty of Physical Therapy, Ahram Canadian university

Giza, Giza Governorate, Egypt

RECRUITING

Out patient clinic , faculty of Physical Therapy, Benha university

Banhā, Qualiobia, Egypt

WITHDRAWN

Out patient clinic , faculty of Physical Therapy, Beni Sueif university

Banī Suwayf, Egypt

WITHDRAWN

Study Officials

  • Mohamed Naeem, Ph.D

    Faculty of Physical Therapy, Beni Sueif university

    STUDY DIRECTOR

Central Study Contacts

Mahmoud Mohamed, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This is a parallel group randomized controlled trial with two arms receiving different interventions.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a parallel group randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 29, 2025

First Posted

August 5, 2025

Study Start

August 5, 2025

Primary Completion (Estimated)

June 10, 2026

Study Completion (Estimated)

August 10, 2026

Last Updated

April 8, 2026

Record last verified: 2025-08

Locations