NCT07103109

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

87
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
Completed

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
completed

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

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
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2026

Completed
Last Updated

September 11, 2026

Status Verified

August 1, 2025

Enrollment Period

1.1 years

First QC Date

July 29, 2025

Last Update Submit

September 9, 2026

Conditions

Keywords

Proximal stabilization

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

EXPERIMENTAL
Other: Proximal Motor Control exercisesOther: Conventional physical therapy

control

ACTIVE COMPARATOR
Other: Conventional physical therapy

Interventions

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.

controlstudy group

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.

study 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:

  • 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

Study Sites (1)

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

Giza, Giza Governorate, Egypt

Location

Study Officials

  • Mohamed Naeem, Ph.D

    Faculty of Physical Therapy, Beni Sueif university

    STUDY DIRECTOR

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
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

September 7, 2026

Study Completion

September 7, 2026

Last Updated

September 11, 2026

Record last verified: 2025-08

Locations