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Clinical Trials/NCT06977620
NCT06977620
Recruiting
Not Applicable

Effect of Closed Kinetic Chain and Weight Shifting Exercises on Postural Stability in Unilateral Post Mastectomy Lymphedema

Cairo University1 site in 1 country60 target enrollmentStarted: April 30, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
60
Locations
1
Primary Endpoint
Kinesis Balance™ fall prevention app

Overview

Brief Summary

Post-mastectomy lymphedema is one of the most common chronic complications that significantly impacts patients' quality of life following breast cancer surgery. postural stability is maintained through the intricate integration of muscular forces, sensory input from mechanoreceptors, and biomechanical feedback. closed kinetic chain (CKC) exercises play a crucial role in enhancing musculoskeletal stability by countering gravitational forces during both rest and movement. weight shifting and balance are fundamental components of functional movement. Proprioceptive training, which focuses on improving body awareness and balance, is essential for developing trunk control

Detailed Description

Sixty patients who have unilateral post mastectomy lymphedema will participate in this study. Their ages will range from 40 to 60 years. The patients will be subdivided randomly into four equal groups.

1.1.a- Group A (n= 15) (CKC group): This group will include 15 patients who will receive closed kinetic chain exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. CDT includes (skin care, manual lymphatic drainage, compression bandages, compression garments and exercises). The total exercise time will be 30 minutes, three times per week for eight weeks.

1.1.b- Group B (n= 15) (WS group): This group will include 15 patients who will receive weight shifting exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. The total exercise time will be 30 minutes, three times per week for eight weeks.

1.1.c- Group C (n= 15) (Combined group): This group will include 15 patients who will receive closed kinetic chain and Weight shifting exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. The total exercise time will be 60 minutes; 30 minutes of CKC and 30 minutes of WS exercise three times per week for eight weeks.

1.1.d- Group D (n= 15) (control group): This group will include 15 patients who will receive complex decongestive therapy (CDT) for the treatment of lymphedema. CDT includes (skin care, manual lymphatic drainage, compression bandages, compression garments and exercises).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

single-blind (participant)

Eligibility Criteria

Ages
40 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Women who had a history of BCRS with upper limb lymphedema. • Age range of 40-60 years.
  • The body mass index (BMI) is less than 30 Kg/m
  • Consciousness and ability to communicate orally or in writing.
  • Treatment by unilateral mastectomy with lymph node dissection.
  • No obvious abnormal spine morphology or postural abnormalities visible to the naked eye.
  • All participants had moderate lymphedema according to the lymphedema severity assessment.

Exclusion Criteria

  • Patients with metastases. • Differences between lower limb length.
  • Having acute or chronic vestibular, neurological, and orthopedic diseases.
  • Surgery related to spine causing limitation of motion.
  • Women with psychiatric disorders, reconstructive surgery.
  • Bilateral mastectomy. Diagnosis with a neurological, skeletal, or rheumatic disorder or other disease that seriously affects body posture.
  • History of bodily injury such as a spinal, shoulder, or neck injury, resulting in permanent alteration of the normal body posture prior to the unilateral mastectomy.
  • Failure to complete follow-up for any reason over the course of the study.
  • Peripheral polyneuropathy, cognitive dysfunction.
  • Patients taking medication that affects body balance.
  • Severe arthritis or orthopedic conditions in their lower extremity

Outcomes

Primary Outcomes

Kinesis Balance™ fall prevention app

Time Frame: Eight weeks

Patients will be instructed to hold the phone firmly against their sternum and stand with their eyes open, in a semi-tandem stance, for 30 s. The app contains audio and visual instructions on how to prepare for and complete the test as well as an audio cue to indicate test start and stop.

Secondary Outcomes

  • Time Up and Go Test (TUG)(Eight weeks)
  • Functional Reach Test (FRT)(Eight weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Aya Kamal Mousa Mohamed

Assistant lecturer

Cairo University

Study Sites (1)

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