Effect of CKC and WS Exercises on Postural Stability in Unilateral Post Mastectomy Lymphedema

NCT06977620 | Recruiting DMC

• 1 other identifier: P.T.REC/012/005746
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Postmastectomy Lymphedema

Keywords

postural stability; closed kinetic chain exercises; weight shifting exercises

Outcome Measures

Primary Outcomes (1)

• Kinesis Balance™ fall prevention app

  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.

  Eight weeks

Secondary Outcomes (2)

• Time Up and Go Test (TUG)

  Eight weeks

• Functional Reach Test (FRT)

  Eight weeks

Study Arms (4)

Group A (CKC group)

ACTIVE COMPARATOR

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.

Other: Closed kinetic chain exercises; Other: Complete Decongestive Therapy

Group B (WS group):

ACTIVE COMPARATOR

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.

Other: Weight shifting exercises; Other: Complete Decongestive Therapy

Group C (Combined group)

ACTIVE COMPARATOR

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

Other: Closed kinetic chain exercises; Other: Weight shifting exercises; Other: Complete Decongestive Therapy

Group D (control group)

PLACEBO COMPARATOR

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).

Other: Complete Decongestive Therapy

Interventions

Closed kinetic chain exercises OTHER

Closed kinetic chain (CKC) exercises emphasize weight-bearing movements where the distal segment of the extremity is fixed, and motion occurs as the proximal segment moves over the stabilized distal segment.

Also known as: CKC

Group A (CKC group); Group C (Combined group)

Weight shifting exercises OTHER

Weight-shifting is a crucial aspect of dynamic postural control, which refers to the ability to maintain one's bodyweight within the base of support. Lateral weight-shifting, in particular, is essential for maintaining posture under dynamic conditions and is commonly performed in various activities of daily living

Also known as: WS

Group B (WS group):; Group C (Combined group)

Complete Decongestive Therapy OTHER

CDT includes (skin care, manual lymphatic drainage, compression bandages, compression garments and exercises).

Also known as: CDT

Group A (CKC group); Group B (WS group):; Group C (Combined group); Group D (control group)

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: Women who had a history of BCRS with upper limb lymphedema
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aya Kamal, PHD

  Teaching Assistant of Physical Therapy for Surgery Cairo University Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aya Kamal, PHD

CONTACT

01030362230; ayakamaline164@gmail.com

Aya Kamal, PHD

CONTACT

01030362230; ayakamaline164@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single-blind (participant)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: 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

Study Record Dates

• First Submitted: May 3, 2025
• First Posted: May 18, 2025
• Study Start: April 30, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: January, 2027
• Access Criteria: Open access

Locations

EG (1)