Immersive Virtual Reality Based Exersice in Post-mastectomy Lymphedema Patients

NCT ID: NCT06553183

Last Updated: 2024-08-14

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-15

Study Completion Date

2025-02-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Lymphedema Arm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

immersive virtual reality

Intervention Type PROCEDURE

Exercise based on virtual reality video games. Immersive type will be used.

traditional physicaltherapy

Intervention Type PROCEDURE

pneumatic compression, exercise and skin care

control group

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

Group Type ACTIVE_COMPARATOR

traditional physicaltherapy

Intervention Type PROCEDURE

pneumatic compression, exercise and skin care

Interventions

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immersive virtual reality

Exercise based on virtual reality video games. Immersive type will be used.

Intervention Type PROCEDURE

traditional physicaltherapy

pneumatic compression, exercise and skin care

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 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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doaa atef

lecturer of physical therapy for surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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doaa atef, PhD

Role: CONTACT

+201060267094 ext. +2

Other Identifiers

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P.T.REC/012/005255

Identifier Type: -

Identifier Source: org_study_id

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