Motor Control Retraining Exercises on Shoulder Dysfunction Post Mastectomy

NCT07002983 | Recruiting DMC

• 1 other identifier: P.T.REC/012/005751
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Motor control and strengthening exercises can improve function in shoulder impingement patients by realigning the scapula and changing muscle recruitment patterns. Peripheral musculoskeletal impairments can be associated with cortical reorganisation. Movement retraining using the principles of motor control retrain muscle recruitment patterns and improve scapular kinematics, reducing subacromial impingement, thus improving function and reducing pain. Furthermore, the need of this study is developed from the lack in the quantitative knowledge and information in the published studies about the effect of motor control retraining exercises on shoulder dysfunction post-mastectomy.

Conditions

Post Mastectomy

Keywords

motor control; shoulder dysfunction; post mastectomy

Outcome Measures

Primary Outcomes (2)

• Instrumented digital hand-held dynamometer

  Hand-held dynamometry (Lafayette manual muscle tester) will be used to measure isometric strength of shoulder flexion and abduction. It is an ergonomic hand-held device for objectively providing reliable, accurate readings that conform to most manual muscle testing protocols. It has good to excellent validity and reliability for most measures of isometric muscle strength particularly for proximal muscle groups.

  8 weeks

• Digital inclinometer

  A digital inclinometer is used to measure shoulder flexion, abduction and upward rotation of scapula. It has digital screen that display the angle at which the inclinometer is situated allowing direct joint angle measurements

  8 weeks

Secondary Outcomes (1)

• Shoulder Pain and Disability Index (SPADI)

  8 weeks

Study Arms (2)

study group (motor control retraining group)

ACTIVE COMPARATOR

This group will include 30 patients with post mastectomy shoulder dysfunction who will receive motor control retraining exercises in addition to their conventional physical therapy program, three sessions per week for 8 weeks, for 45:60 minutes according to patient's ability

Other: motor control retraining exercises; Other: traditional physical therapy for shoulder dysfunction

control group ( conventional treatment group)

PLACEBO COMPARATOR

This group will include 30 patients with post mastectomy shoulder dysfunction who will receive conventional physical therapy program in the form of shoulder joint mobilization, posterior capsule stretching and shoulder range of motion exercise (ROM) (Codman's pendulum exercises) for 30 minutes according to patient's ability, three sessions per week for 8 weeks

Other: traditional physical therapy for shoulder dysfunction

Interventions

motor control retraining exercises OTHER

The motor control retraining package was targeted at correcting movement impairments of the scapula by re-educating muscle recruitment. There were two components to the package: 1. Motor control exercises to correct alignment and coordination, which involve a) learning optimal scapular orientation at rest and then controlling optimal orientation during active arm movements; b) muscle specific exercises for trapezius and serratus anterior 2. Manual therapy techniques commonly used in clinical practice to manage symptoms, as trigger point therapy and pectoralis minor supine manual stretch will be performed as necessary.

study group (motor control retraining group)

traditional physical therapy for shoulder dysfunction OTHER

shoulder joint mobilization, posterior capsule stretching and shoulder range of motion exercise (ROM) (Codman's pendulum exercises)

Also known as: conventional treatment

control group ( conventional treatment group); study group (motor control retraining group)

Eligibility Criteria

• Age: 40 Years - 55 Years
• Gender Eligibility Details: females who have shoulder dysfunction post mastectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The subject selection will be according to the following criteria:
• Female patients with age range between 40-55 years.
• All patients have shoulder dysfunction.
• Patients were 2 months to 4 months post modified radical mastectomy or axillary lymph node dissection.
• Patients received their radiotherapy or chemotherapy or both.

You may not qualify if:

• The potential participants will be excluded if they meet one of the following criteria:
• Rheumatoid arthritis.
• History of trauma or accidental injuries.
• Neurological involvement (stroke, Parkinsonism).
• History of surgery on involved shoulder.
• Diabetic patient.
• Moderate and severe lymphoedema.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Egypt

RECRUITING

Study Officials

• Esraa Tarek, PhD

  Teaching assistant physical therapy for surgery cairo university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esraa Tarek, PhD

CONTACT

01150176783; esraatarek94@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single blind participant
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Model Details: the study will be 2 armed, single blind, parallel group, randomized controlled trial

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 4, 2025
• Study Start: May 5, 2025
• Primary Completion: May 5, 2026
• Study Completion: May 5, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: january, 2027
• Access Criteria: open access

Locations

EG (1)