NCT07316283

Brief Summary

Forty-six female patients aged 35-55 years who were suffering from shoulder dysfunction following mastectomy surgeries participated in this study. The participants were recruited from the outpatient clinic of the Faculty of Physical Therapy, Cairo University, and were randomly assigned into two equal groups. Group A: consisted of 23 patients who received sensorimotor training exercises in addition to a traditional physical therapy program which included shoulder range of motion exercises, capsular stretching exercises, scapular muscle strengthening exercises, shoulder Maitland mobilization, and scapular mobilization. Group B: consisted of 23 patients who received only the traditional physical therapy program, which included shoulder range of motion exercises, capsular stretching exercises, scapular muscle strengthening exercises, shoulder Maitland mobilization, and scapular mobilization. Both groups received treatment three sessions per week for a duration of eight weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

September 16, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 17, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 5, 2026

Completed
Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

December 17, 2025

Last Update Submit

December 30, 2025

Conditions

Keywords

Sensorimotor training exercisesShoulder position sensePost mastectomy

Outcome Measures

Primary Outcomes (1)

  • ShoulderJoint Position Sense

    A digital inclinometer was used as a validated and reliable tool to assess joint position sense (JPS). It measured the participants' ability to accurately reproduce specific joint angles, providing objective data on proprioceptive accuracy.

    8 weeks

Study Arms (2)

Sensorimotor Training Exercises Plus Traditional Physical Therapy Program.

EXPERIMENTAL

Sensorimotor training exercises in addition to the traditional physical therapy program (shoulder ROM exercises, capsular stretching exercises, scapular muscle strengthening exercises, and scapular mobilization) were applied three sessions per week for eight weeks. Patients tracked a diagram fixed on the wall using a laser pointer, threw and caught a medicine ball, performed upper-limb weight-bearing exercises on a Swiss ball, and executed wall exercises using a ball. The exercises were performed in three sets of ten repetitions, with one minute of rest between sets, three times per week for eight weeks. Traditional physical therapy program included scapular retraction exercises with moderate resistance from standing, shoulder ROM exercises using a shoulder wheel and ladder in flexion and abduction, scapular mobilization from sitting, shoulder Maitland mobilization (inferior, anterior, and posterior glides), and posterior capsule stretching from sitting with two sets of 15 repetitions

Behavioral: Sensorimotor Training ExercisesBehavioral: Traditional Physical Therapy Program

Traditional Physical Therapy Program

EXPERIMENTAL

Traditional physical therapy program 3 sessions per week for 8 weeks included scapular retraction exercises with moderate resistance from standing, shoulder ROM ex on shoulder wheel and ladder in flexion and abduction, scapular mobilization from sitting, shoulder Mitland mobilization as inferior glide, anterior glide and posterior glide, and posterior capsule stretching from sitting with approximately two sets of 15 repetitions.

Behavioral: Traditional Physical Therapy Program

Interventions

The traditional physical therapy program consisted of scapular retraction exercises with moderate resistance from standing, shoulder range of motion exercises using a shoulder wheel and ladder in flexion and abduction, scapular mobilization from a seated position, shoulder Maitland mobilization including inferior, anterior, and posterior glides, and posterior capsule stretching from a seated position, performed in approximately two sets of fifteen repetitions.

Sensorimotor Training Exercises Plus Traditional Physical Therapy Program.Traditional Physical Therapy Program

Sensorimotor training exercises, in addition to the traditional physical therapy program which included shoulder ROM exercises, capsular stretching exercises, scapular muscle strengthening exercises, and scapular mobilization were applied three sessions per week for eight weeks. Patients tracked a diagram fixed on the wall using a laser pointer, threw and caught a medicine ball, performed upper-limb weight-bearing exercises on a Swiss ball, and executed wall exercises using a ball. Each exercise was performed in three sets of ten repetitions, with one minute of rest between sets. The traditional physical therapy program also included scapular retraction exercises with moderate resistance from standing, shoulder ROM exercises using a shoulder wheel and ladder in flexion and abduction, scapular mobilization from sitting, shoulder Maitland mobilization (inferior, anterior, and posterior glides), and posterior capsule stretching from sitting with two sets of fifteen repetitions.

Sensorimotor Training Exercises Plus Traditional Physical Therapy Program.

Eligibility Criteria

Age35 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale patients
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female patients
  • Aged between 35 and 55 years
  • Underwent unilateral mastectomy
  • Underwent wide local excision
  • Underwent axillary dissection
  • Presence of shoulder joint dysfunction
  • Conscious and able to communicate orally or in writing
  • No obvious abnormal spinal morphology or postural abnormalities visible to the naked eye

You may not qualify if:

  • History of fracture or upper limb surgery within the last 3 months
  • History of previous shoulder dislocation or chronic shoulder instability
  • Uncontrolled diabetes mellitus
  • Inability to communicate effectively or write
  • Presence of cognitive, visual, or hearing impairments
  • Neurological conditions affecting the upper extremity
  • Moderate to severe upper limb lymphedema
  • Prior permanent shoulder injury before mastectomy
  • Poor physical conditioning or acute pain due to any cause or comorbidity
  • Participation in another clinical trial or study that could interfere with the results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Giza, 12613, Egypt

Location

Study Officials

  • Huda Tarek Abuassi

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator at Department of Surgery and Burn - Faculty of Physical Therapy - Cairo University

Study Record Dates

First Submitted

December 17, 2025

First Posted

January 5, 2026

Study Start

September 16, 2025

Primary Completion

November 16, 2025

Study Completion

December 16, 2025

Last Updated

January 5, 2026

Record last verified: 2025-12

Locations