NCT06652282

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

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2024

Completed
Last Updated

October 22, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

October 20, 2024

Last Update Submit

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

EXPERIMENTAL

This 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

Other: Pilates exercises

proprioceptive neuromuscular facilitation (PNF)

ACTIVE COMPARATOR

This 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

Other: proprioceptive neuromuscular facilitation

Conventional exercise

ACTIVE COMPARATOR

This 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

Other: The conventional program

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.

Pilates exercise

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.

proprioceptive neuromuscular facilitation (PNF)

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

Conventional exercise

Eligibility Criteria

Age40 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAll females who have no diabetes or blood problems.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

out-patient clinic, faculty of physical therapy, Cairo university

Giza, Egypt

Location

MeSH Terms

Interventions

Exercise Movement TechniquesMuscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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

Locations