Impact of Proximal Motor Control Exercise on Scapular Muscles Activation Pattern in Breast Cancer Survivors Following Mastectomy
1 other identifier
interventional
60
1 country
1
Brief Summary
This prospective, single-center, assessor-blinded, parallel-group randomized controlled trial investigated whether adding proximal motor control exercises (PMCE) to conventional physiotherapy treatment (CPT) improved shoulder function and scapular muscle activation in women with post-mastectomy shoulder dysfunction. Women aged 35-55 years were randomly allocated to receive either PMCE plus CPT or CPT alone. Both groups attended supervised physiotherapy sessions three times weekly for 6 weeks. Outcomes were assessed at baseline, immediately after treatment, and at 12-week follow-up. The primary outcome was scapular and shoulder muscle activation assessed using surface electromyography (SEMG), while secondary outcomes included shoulder pain and disability assessed using the Shoulder Pain and Disability Index (SPADI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2025
1 active site
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
First Submitted
Initial submission to the registry
July 29, 2025
CompletedFirst Posted
Study publicly available on registry
August 5, 2025
CompletedStudy Start
First participant enrolled
August 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 7, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 7, 2026
CompletedSeptember 11, 2026
August 1, 2025
1.1 years
July 29, 2025
September 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
EMG Muscle Activation
Surface electromyography (sEMG) was used to assess the activation patterns of the serratus anterior, upper and lower trapezius, supraspinatus, and infraspinatus muscles during arm elevation. The sEMG assessment was 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 were placed over the muscle bellies according to the SENIAM recommendations, with an inter-electrode distance of 20 mm.
Baseline, 6 weeks and 12 weeks follow up
Secondary Outcomes (1)
Shoulder pain and disability index (SPADI)
Baseline, 6 weeks and 12 weeks follow up
Study Arms (2)
study group
EXPERIMENTALcontrol
ACTIVE COMPARATORInterventions
CPT consisted of glenohumeral joint mobilization, posterior capsule stretching, and Codman pendulum exercises. Joint mobilization included distraction, caudal, and posterior glides using Grade 1-2 oscillations for approximately 2 minutes. Posterior capsule stretching was performed with the shoulder at 90° flexion, holding each stretch for 20 seconds for 10 repetitions with 30 seconds of rest. Codman pendulum exercises were performed in anterior-posterior, medial-lateral, and circular directions without resistance to facilitate gentle shoulder mobility. The CPT program was administered three times per week for six consecutive weeks.
The PMCE program was: Participants were trained to achieve and maintain optimal scapular positioning using visual, verbal, tactile, and kinesthetic feedback, followed by controlled arm elevation to 90° in the sagittal, frontal, and scapular planes. Muscle-specific exercises included prone 135° elevation for the lower trapezius, wall slides with scapular protraction for the serratus anterior, full-can scaption for the supraspinatus, and resisted external rotation for the infraspinatus. Upper trapezius activation was incorporated during controlled arm elevation. Exercises were performed for three sets of 10 repetitions with 6-second holds and 60-90 seconds of rest. Resistance started at approximately 0.5-1.0 kg and was progressively increased according to the participant's ability to maintain proper scapular alignment without compensatory movement or increased symptoms. The PMCE program was administered three times per week for six consecutive weeks.
Eligibility Criteria
You may qualify if:
- Had stage I-III unilateral breast cancer. Had undergone simple or modified radical mastectomy at least 3 months before enrollment.
- Had achieved complete postoperative wound healing and were medically stable. Had clearance from their treating physician to participate in exercise. Presented with post-mastectomy shoulder dysfunction, defined as a SPADI score ≥30/100 and a positive Scapular Dyskinesis Test.
You may not qualify if:
- Had undergone bilateral mastectomy. Had evidence of locoregional recurrence or metastatic breast cancer. Had a history of previous shoulder surgery or major shoulder trauma unrelated to breast cancer treatment.
- Had pre-existing shoulder disorders, including rotator cuff tears, adhesive capsulitis, or advanced glenohumeral osteoarthritis.
- Had neurological disorders affecting upper-limb function. Had rheumatologic diseases affecting shoulder function. Had uncontrolled diabetes mellitus or any other medical condition contraindicating exercise participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ahram Canadian Universitylead
- Benha Universitycollaborator
Study Sites (1)
Out patient clinic , faculty of Physical Therapy, Ahram Canadian university
Giza, Giza Governorate, Egypt
Study Officials
- STUDY DIRECTOR
Mohamed Naeem, Ph.D
Faculty of Physical Therapy, Beni Sueif university
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The SPADI assessor, SEMG examiner, and statistician remained blinded to group allocation throughout data collection and analysis.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- 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
September 7, 2026
Study Completion
September 7, 2026
Last Updated
September 11, 2026
Record last verified: 2025-08