Pilates Exercise Versus Proprioceptive Neuromuscular Facilitation in Shoulder Dysfunction Post Mastectomy
Effect of Pilates Exercise Versus Proprioceptive Neuromuscular Facilitation in Shoulder Dysfunction Post Mastectomy
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of the study was done to evaluate the therapeutic efficacy of Pilates versus PNF in treatment of shoulder dysfunction and limitation of range of motion after mastectomy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2023
Shorter than P25 for not_applicable
1 active site
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
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedFirst Submitted
Initial submission to the registry
October 20, 2024
CompletedFirst Posted
Study publicly available on registry
October 22, 2024
CompletedOctober 22, 2024
October 1, 2024
4 months
October 20, 2024
October 21, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
assessment of the change of shoulder range of motion using Software/Smartphone-based Goniometer
Smartphones can be used as digital goniometers, offering benefits like convenience, ease of measurement, application-based tracking, and one-hand use. These applications use accelerometers to calculate joint angles. Patients with muscle issues, such as abduction and flexion, may experience reduced range of movement due to muscle bulk loss and bony leverage. However, these patients can compensate with the opposite arm, reducing the impact on daily activities.
at baseline and 3 months
Secondary Outcomes (1)
Composite assessment of pain and disability using Shoulder pain and disability index
at baseline and 3 months
Study Arms (3)
Pilates exercise
EXPERIMENTALThis group includes 20 patients who had mastectomy and will recieve Pilates exercise in addition to conventional physical therapy program (stretching exercises and strengthening exercises), and routine medical treatment. Patients will receive 3 sessions per week for 12 weeks, time of session is 45 - 60 min according to patient ability
proprioceptive neuromuscular facilitation (PNF)
ACTIVE COMPARATORThis group includes 20 patients who had mastectomy and will receive PNF exercise in addition to conventional physical therapy program (stretching exercises and strengthening exercises) and routine medical treatment. Patients will receive 3 sessions per week for 12 weeks, time of session is 45 - 60 min according to patient ability
Conventional exercise
ACTIVE COMPARATORThis group includes 20 patients who had mastectomy and will receive conventional physical therapy program (stretching exercises and strengthening exercises) and routine medical treatment. Patients will receive 3 sessions per week for 12 weeks, time of session is 45 - 60 min according to patient ability
Interventions
Before starting the training program, patients will learn key Pilates elements, including diaphragmatic breathing, neutral position, rib cage placement, shoulder placement, and head and neck placement. The exercise program includes Pilates-based mat exercises and Pilates-based theraband exercises, with patients placed in supine, prone, and kneeling positions to perform exercises for the affected shoulder. The patient will be placed in various positions for optimal results.
Before starting the training program, patients will learn key Pilates elements, including diaphragmatic breathing, neutral position, rib cage placement, shoulder placement, and head and neck placement. The exercise program includes Pilates-based mat exercises and Pilates-based theraband exercises, with patients placed in supine, prone, and kneeling positions to perform exercises for the affected shoulder. The patient will be placed in various positions for optimal results.
Each patient was in the supine position and will receive stretching exercise for the flexors and adductors, and strengthening for the extensors, abductors and scapular stabilizers of the affected shoulder
Eligibility Criteria
You may qualify if:
- Age range between 40-75 years.
- Only females will participate in the study.
- All patients have no diabetes or blood problems.
- All patients enrolled to the study will have their informed consent
You may not qualify if:
- Age less than 40 or more than 75 years.
- Diabetes mellitus.
- 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
- Cairo Universitylead
Study Sites (1)
out-patient clinic, faculty of physical therapy, Cairo university
Giza, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
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
October 20, 2024
First Posted
October 22, 2024
Study Start
November 1, 2023
Primary Completion
March 1, 2024
Study Completion
August 1, 2024
Last Updated
October 22, 2024
Record last verified: 2024-10