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

Primary Purpose

Postmastectomy Lymphedema

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

traditional physical therapy session

wii console based exercise

About this trial

This is an interventional treatment trial for Postmastectomy Lymphedema

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Faculty of Physical TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

wii console based exercise group

control group

Arm Description

the patient will recieve wii console based exercise in addition to traditional physical therapy session

the patient will recieve only the traditional physical therapy session

Outcomes

Primary Outcome Measures

shoulder range of motion

flexion, extension, abduction, adduction , internal rotation and external rotation

Secondary Outcome Measures

Full Information

NCT ID

NCT05726656

First Posted

February 3, 2023

Last Updated

September 17, 2023

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT05726656

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2022 (Actual)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postmastectomy Lymphedema

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

wii console based exercise group

Arm Type

Experimental

Arm Description

the patient will recieve wii console based exercise in addition to traditional physical therapy session

Arm Title

control group

Arm Type

Other

Arm Description

the patient will recieve only the traditional physical therapy session

Intervention Type

Other

Intervention Name(s)

traditional physical therapy session

Intervention Description

manual lymph drainage-pneumatic compression and skin care

Intervention Type

Other

Intervention Name(s)

wii console based exercise

Intervention Description

execise session using the wii console video games

Primary Outcome Measure Information:

Title

shoulder range of motion

Description

flexion, extension, abduction, adduction , internal rotation and external rotation

Time Frame

4 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Doaa A Atef, PHD

Phone

01060267094

Ext

002

doozy.masr@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Doaa A Atef, PHD

Organizational Affiliation

Cairo University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Physical Therapy

City

Giza

ZIP/Postal Code

11432

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Doaa A Atef, PHD

Phone

01060267094

Ext

002

doozy.masr@gmail.com

First Name & Middle Initial & Last Name & Degree

Ayah M Mohamed, PHD

First Name & Middle Initial & Last Name & Degree

Amany R Mohamed, PHD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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