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

NCT ID: NCT06977620

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2026-05-31

Brief Summary

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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

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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).

Conditions

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Postmastectomy Lymphedema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
single-blind (participant)

Study Groups

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Group A (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.

Group Type ACTIVE_COMPARATOR

Closed kinetic chain exercises

Intervention Type 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.

Complete Decongestive Therapy

Intervention Type OTHER

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

Group B (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.

Group Type ACTIVE_COMPARATOR

Weight shifting exercises

Intervention Type 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

Complete Decongestive Therapy

Intervention Type OTHER

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

Group C (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

Group Type ACTIVE_COMPARATOR

Closed kinetic chain exercises

Intervention Type 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.

Weight shifting exercises

Intervention Type 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

Complete Decongestive Therapy

Intervention Type OTHER

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

Group D (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).

Group Type PLACEBO_COMPARATOR

Complete Decongestive Therapy

Intervention Type OTHER

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

Interventions

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Closed kinetic chain exercises

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.

Intervention Type OTHER

Weight shifting exercises

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

Intervention Type OTHER

Complete Decongestive Therapy

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

Intervention Type OTHER

Other Intervention Names

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CKC WS CDT

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Aya Kamal Mousa Mohamed

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aya Kamal, PHD

Role: PRINCIPAL_INVESTIGATOR

Teaching Assistant of Physical Therapy for Surgery Cairo University Egypt

Locations

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Cairo University

Giza, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Aya Kamal, PHD

Role: CONTACT

01030362230

Aya Kamal, PHD

Role: CONTACT

01030362230

Facility Contacts

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Aya Kamal, PHD

Role: primary

01030362230

Aya Kamal, PHD

Role: backup

01030362230

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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P.T.REC/012/005746

Identifier Type: -

Identifier Source: org_study_id

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