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
Sponsored by
About this trial
This is an interventional treatment trial for Postmastectomy Lymphedema
Eligibility Criteria
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
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
No
Studies a U.S. FDA-regulated Device Product
No
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
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Doaa A Atef, PHD
Phone
01060267094
Ext
002
Email
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
Email
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
No
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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