Immersive Virtual Reality Based Exersice in Post-mastectomy Lymphedema Patients

August 12, 2024 updated by: doaa atef, Cairo University

Immersive Virtual Reality Based Exersice and Shoulder Proprioception and Range of Motion in Post-mastectomy Lymphedema Patients

To determine the effect of immersive virtual reality on shoulder proprioception and ROM of post-mastectomy lymphedema patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

RESEARCH QUESTION:

Does Immersive virtual reality based exercise effective in improving shoulder proprioception and ROM for post-mastectomy patients?

Assessment:

The digital goniometer will be used in measuring shoulder extension, flexion, adduction, abduction, internal rotation and external rotation before the sessions and after one month of sessions. Also, shoulder proprioception will be assessed by the digital goniometer.The measurement will be taken for both the edematous side and the non-affected side.

Treatment:

Study group: the patients will receive eight sessions of Immersive virtual reality based exercise, 2 sessions per week for 4 weeks besides the traditional physical therapy.

Control group: the patients will receive eight sessions of the traditional physical therapy, 2 sessions per week for 4 weeks.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All the patients will be females.
  • Patients with lymph node dissection.
  • start at least 2 weeks after operation.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group
the patients will receive eight sessions of Immersive virtual reality based exercise, 2 sessions per week for 4 weeks besides the traditional physical therapy.
Procedure: immersive virtual reality
Exercise based on virtual reality video games. Immersive type will be used.
Procedure: traditional physicaltherapy
pneumatic compression, exercise and skin care
Active Comparator: control group
the patients will receive eight sessions of the traditional physical therapy, 2 sessions per week for 4 weeks.
Procedure: traditional physicaltherapy
pneumatic compression, exercise and skin care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
shoulder proprioception
Time Frame: 4 weeks
digital goniometer
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
shoulder ROM
Time Frame: 4 weeks
all 6 motions will be measured by digital goniometer
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 15, 2024

Primary Completion (Estimated)

January 15, 2025

Study Completion (Estimated)

February 15, 2025

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 12, 2024

First Posted (Actual)

August 14, 2024

Study Record Updates

Last Update Posted (Actual)

August 14, 2024

Last Update Submitted That Met QC Criteria

August 12, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/005255

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lymphedema Arm

Clinical Trials on immersive virtual reality

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe