NCT07023913

Brief Summary

The purpose of this study is to evaluate the effect of kinetic control exercises on shoulder dysfunction in post-mastectomy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

June 15, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
Last Updated

June 17, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

June 2, 2025

Last Update Submit

June 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • assessment of change of range of motion

    Patients will be seated with their affected limb relaxed, and their goniometer will measure their resting position and active range. They will measure shoulder abduction and flexion, which are rarely affected by day-to-day activities, and external shoulder rotation.

    at baseline and after 8 weeks

Secondary Outcomes (2)

  • assessment of ability to maintain controlled shoulder movements while stabilizing the scapular and shoulder

    at baseline and after 8 weeks

  • assessment of ability to maintain controlled shoulder movements while stabilizing the scapular and shoulder

    at baseline and after 8 weeks

Study Arms (2)

Kinetic Control Exercise

EXPERIMENTAL

This group includes 30 patients who had mastectomy and will receive Kinetic control exercise inform of activation local and general Stabilizer, mobilizer), and traditional exercise. Patients will receive 3 sessions per week for 8 weeks.

Other: kinetic Control exercisesOther: traditional treatment

traditional therapy

ACTIVE COMPARATOR

This group includes 30 patients who have undergone mastectomy and will receive traditional therapy inform of stretching and strengthening exercise as shoulder roll, arm circle, wall climb, back climb and hand behind neck. Patients will receive 3 sessions per week for 8 weeks.

Other: traditional treatment

Interventions

Kinetic Control exercises consist of 45-minute sessions, with 3 sessions per week for 8 weeks. The framework for testing and rehabilitation includes initial assessment, rehabilitation before failure, and retesting the same position. Biofeedback measures scapular retraction, and biofeedback pressure training assesses and improves scapular stabilizer control by monitoring pressure changes during specific movements.

Kinetic Control Exercise

traditional therapy inform of stretching and strengthening exercise as shoulder roll, arm circle, wall climb, back climb and hand behind neck. Patients will receive 3 sessions per week for 8 weeks, the time of session is 45 - 60 min according to patient ability

Kinetic Control Exercisetraditional therapy

Eligibility Criteria

Age40 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Details60 female patient who will undergo mastectomy and suffers from post shoulder dysfunction. Their age will range from 40 to 50.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The subject selection will be according to the following criteria:
  • Age from 40 to 50 years.
  • All patients have no diabetes or blood problems.
  • All patients enrolled to the study will have their informed consent.

You may not qualify if:

  • The potential participants will be excluded if they meet one of the following criteria:
  • Age less than 40 or more 50 years.
  • Diabetes mellitus.
  • Subjects with lymphedema
  • Subjects suffering from active malignant tumors.
  • Subjects treated with skin graft.
  • Subjects with Mental illness.
  • Subjects with skin diseases
  • Subjects with any previous cause for shoulder dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

learning hospitals Al Kaser Al Ayni hospital

Cairo, Egypt

Location

Central Study Contacts

Alaa Tarek Mostafa Elnawawy, physical therapist

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 2, 2025

First Posted

June 17, 2025

Study Start

June 15, 2025

Primary Completion

September 15, 2025

Study Completion

October 15, 2025

Last Updated

June 17, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations