NCT07240129

Brief Summary

One of the most common complications after breast cancer surgery is a functional limitation of the upper body. Up to 67% of breast cancer patients experience arm or shoulder impairment, including pain, numbness, loss of strength, and reduced ROM, after surgery. Graded motor imagery is effective in reducing pain interference with function using a graded sequence of strategies including left/right judgements (implicit motor imagery), imagined movements (explicit motor imagery) and mirror therapy.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

April 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

June 26, 2025

Last Update Submit

November 19, 2025

Conditions

Keywords

Graded Motor ImageryPost Mastectomy

Outcome Measures

Primary Outcomes (2)

  • Digital goniometer

    A device which measures joint ranges.

    From baseline to 6 weeks

  • Handgrip dynamometer

    A valid tool for measuring handgrip strength in kilograms that provides an objective overview of upper limb functional integrity

    From baseline to 6 weeks

Secondary Outcomes (2)

  • Visual analog scale

    From baseline to 6 weeks

  • Shoulder Pain and Disability Index

    From baseline to 6 weeks

Study Arms (2)

Group A (study group)

ACTIVE COMPARATOR

This group includes 27 patients who will receive graded motor imagery (GMI) along with the conventional physiotherapy (It will include exercise like codman's pendulum exercises in flexion-extension, abduction-adduction, and circular motion, active assisted ROM exercises with a wand, capsular stretching, wall ladder, and shoulder wheel exercises). GMI is consists of a three-step process. Each step of will be carried out for two weeks, for 30 minutes on two separate days, for total 6 weeks

Other: Graded Motor Imagery (GMI)Other: Physical therapy program

Group B (control group)

PLACEBO COMPARATOR

This group includes 27 patients who will receive conventional physiotherapy treatment for improving ROM and decreasing pain. It will include exercise like codman's pendulum exercises in flexion-extension, abduction-adduction, and circular motion, active assisted ROM exercises with a wand, capsular stretching, wall ladder, and shoulder wheel exercises, 2 times / week for 6 weeks

Other: Physical therapy program

Interventions

1. Left/right judgements: It includes left/right judgments of photographs that depict the affected area. 2. Imagined movements: Movement visualizations will be performed. 3. Mirror therapy: It includes observation of the movements of unaffected body part in the mirror, 2 times / week for 6 weeks.

Group A (study group)

It will include exercise like codman's pendulum exercises in flexion-extension, abduction-adduction, and circular motion, active assisted ROM exercises with a wand, capsular stretching, wall ladder, and shoulder wheel exercises, 2 times / week for 6 weeks.

Also known as: A group of exercises
Group A (study group)Group B (control group)

Eligibility Criteria

Age35 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEligibility is based on biological gender
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age range of 35 to 55 years.
  • All patients are post-mastectomized unilaterally.
  • Female patients only.
  • Patients have shoulder ROM restriction.
  • Patients have shoulder pain more than 3 months (chronic).
  • After 3 months post-surgery.

You may not qualify if:

  • Having double mastectomy.
  • Psychopathological disorders.
  • Having other orthopedic problems (e.g. tendinitis, dislocation, osteoarthritis, referred pain to shoulder).
  • Motor problems (e.g. tremor, dyskinesia).
  • Metastasis.
  • Visual impairment such that they could not read unaided or with their reading glasses.
  • Having previously received GMI treatment.
  • Diabetes mellitus.
  • Having neurological problems as hemiplegia.
  • Patients with lymphedema

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Egypt

Location

Study Officials

  • Asmaa Abdallah, PhD

    Teaching assistant of physical therapy for surgery, cairo university, egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Singl blind (participants)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Design of the study: In this study the patients will be randomly assigned into two equal groups (27 patients for each group)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

June 26, 2025

First Posted

November 20, 2025

Study Start

April 30, 2025

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations