- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07240129
Effect of Graded Motor Imagery on Shoulder Dysfunction Post Mastectomy
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
54 female patients who have shoulder dysfunction post-mastectomy will participate in this study. Their ages will be ranged 35 to 55 years.
In this study the patients will be randomly assigned into two equal groups (27 patients for each group):
Group A (study group):
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.
- Group B (control group):
This group includes 27 patients who will receive conventional physiotherapy treatment. 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Giza, Egypt
- Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group A (study group)
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
|
It includes observation of the movements of unaffected body part in the mirror, 2 times / week for 6 weeks.
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 Names:
|
|
Placebo Comparator: Group B (control group)
This group includes 27 patients who will receive conventional physiotherapy treatment.
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
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analog scale
Time Frame: From baseline to 6 weeks
|
A validated, subjective measure for acute and chronic pain.
Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 means "no pain" and 10 means "worst pain."
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From baseline to 6 weeks
|
|
Smartphone clinometer application
Time Frame: From baseline to 6 weeks
|
The smartphone clinometer application has excellent agreement with a goniometer-based gold standard for measurement of shoulder ROM in both healthy subjects and symptomatic patients.
|
From baseline to 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder Pain and Disability Index
Time Frame: From baseline to 6 weeks
|
Is a self-administered questionnaire that aims to measure pain and disability associated with shoulder disease with lower scores indicate little pain or disability and higher scores indicate higher pain and disability
|
From baseline to 6 weeks
|
|
Handheld dynamometer
Time Frame: From baseline to 6 weeks
|
A valid tool for measuring isometric muscle strength in kilograms/newton that provides an objective overview of shoulder flexor and abductor muscles strength
|
From baseline to 6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Asmaa Abdallah, PhD, Teaching assistant of physical therapy for surgery, cairo university, egypt
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- P.T.REC/012/005749
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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