Clinical trial NCT07002983: Motor Control Retraining Exercises on Shoulder Dysfunction Post Mastectomy
Official title: Motor Control Retraining Exercises On Shoulder Dysfunction Post Mastectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Mastectomy
Keywords: motor control
shoulder dysfunction
post mastectomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the study will be 2 armed, single blind, parallel group, randomized controlled trial
Primary purpose: TREATMENT

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.

Detailed description: sixty patients suffering from post-mastectomy shoulder dysfunction will participate in this study. Their ages will range from 40 to 55 years. The participants will be selected from Cairo university hospitals.

Design of the study:

In this randomised controlled trial study (RCT), the patients will be randomly assigned into two equal groups (30 patients for each group):

Group A (study group):

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.

Group B (control group):

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.

Measurement equipment:

* Hand-held dynamometer: for measurement of muscle strength.
* Digital inclinometer: for measurement of shoulder flexion, abduction and scapular upward rotation.
* Shoulder Pain and Disability Index (SPADI): for measurement of shoulder disability.

Therapeutic procedures:

• Motor control retraining exercises of the scapular musculature.

Motor control retraining exercises:

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.

   * Traditional physical therapy.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Instrumented digital hand-held dynamometer
timeFrame: 8 weeks
measure: Digital inclinometer
timeFrame: 8 weeks
Secondary outcomes:
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
affiliation: Teaching assistant physical therapy for surgery cairo university
name: Esraa Tarek, PhD
role: PRINCIPAL_INVESTIGATOR
References: