Effect of Wii-console Based Exercise on Shoulder Range of Motion for Post-mastectomy Lymphedema Patients

Effect of Wii-console Based Exercise on Shoulder Range of Motion for Post-mastectomy

PURPOSE: To determine the effect of wii-console based exercise on shoulder ROM of both sides for post-mastectomy patients, and highlighting the effect of dominancy.

Study Overview

• Status: Recruiting
• Conditions: Postmastectomy Lymphedema
• Intervention / Treatment: Other: traditional physical therapy session; Other: wii console based exercise

Detailed Description

Breast cancer has been the focused of many studies because it significantly affects both in developed and developing countries worldwide (Cameirão et al, 2008).

Lymphedema affects the range of motion of shoulder causing disability and affection of function.

Wii-console systems can be used as training tools to promote intensive training directed towards specific deficits and guide the patients in task-oriented activities. Moreover, it allows a real-time high-resolution monitoring, where is possible to have a quantitative assessment of relevant properties of the impairment, performance and recovery. On the other hand, virtual reality environment demand focus and attention of the patient, motivate the patient to perform the exercises, and provide a sense of achievement to the user (Torre et al, 2015).

HYPOTHESES:

The wii-console based exercise will have no effect on shoulder ROM for post-mastectomy patients.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Doaa A Atef, PHD; Phone Number: 002 01060267094; Email: doozy.masr@gmail.com

Study Locations

• Egypt
  • Giza, Egypt, 11432
    • Recruiting
    • Faculty of physical therapy
    • Contact: Doaa A Atef, PHD; Phone Number: 002 01060267094; Email: doozy.masr@gmail.com
    • Sub-Investigator: Ayah M Mohamed, PHD
    • Sub-Investigator: Amany R Mohamed, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All the patients will be females.
• Patients undergone mastectomy with lymph nodes dissection.
• all developed lymphedema after the surgery.

Exclusion Criteria:

• Vision problems.
• Medically instable patients.
• Balance disorders.
• Other musculoskeletal condition of shoulders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: wii console based exercise group; the patient will recieve wii console based exercise in addition to traditional physical therapy session	Other: traditional physical therapy session; manual lymph drainage-pneumatic compression and skin care; Other: wii console based exercise; execise session using the wii console video games
Other: control group; the patient will recieve only the traditional physical therapy session	Other: traditional physical therapy session; manual lymph drainage-pneumatic compression and skin care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
shoulder range of motion	flexion, extension, abduction, adduction , internal rotation and external rotation	4 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Doaa A Atef, PHD, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 14, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 17, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Lymphatic Diseases; Postoperative Complications; Lymphedema; Breast Cancer Lymphedema
• Other Study ID Numbers: P.T.REC/012/004199

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No