Clinical trial NCT06977620: Effect of CKC and WS Exercises on Postural Stability in Unilateral Post Mastectomy Lymphedema
Official title: Effect of Closed Kinetic Chain and Weight Shifting Exercises on Postural Stability in Unilateral Post Mastectomy Lymphedema
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postmastectomy Lymphedema
Keywords: postural stability
closed kinetic chain exercises
weight shifting exercises
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be four-armed, single-blind (participant), parallel-group, randomized control trial. 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 by using simple randomization technique 1:1 ratio to four equal groups according to sample size calculation
Primary purpose: TREATMENT

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).

Eligibility criteria: 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/m2.

• 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

• Poor conditioning, acute pain in any reason,

• Neurological disorders including visual problems.

Primary outcomes:
measure: Kinesis Balance™ fall prevention app
timeFrame: Eight weeks
Secondary outcomes:
measure: Time Up and Go Test (TUG)
timeFrame: Eight weeks
measure: Functional Reach Test (FRT)
timeFrame: Eight weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
affiliation: Teaching Assistant of Physical Therapy for Surgery Cairo University Egypt
name: Aya Kamal, PHD
role: PRINCIPAL_INVESTIGATOR
References: