NCT06553183

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 14, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

August 15, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2025

Completed
Last Updated

August 14, 2024

Status Verified

August 1, 2024

Enrollment Period

5 months

First QC Date

August 8, 2024

Last Update Submit

August 12, 2024

Conditions

Lymphedema Arm

Outcome Measures

Primary Outcomes (1)

  • shoulder proprioception

    digital goniometer

    4 weeks

Secondary Outcomes (1)

  • shoulder ROM

    4 weeks

Study Arms (2)

study group

EXPERIMENTAL

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 realityProcedure: traditional physicaltherapy

control group

ACTIVE COMPARATOR

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

Procedure: traditional physicaltherapy

Interventions

immersive virtual realityPROCEDURE

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

study group
traditional physicaltherapyPROCEDURE

pneumatic compression, exercise and skin care

control groupstudy group

Eligibility Criteria

Age35 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

doaa atef, PhD

CONTACT

+201060267094doozy.masr@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy for surgery

Study Record Dates

First Submitted

August 8, 2024

First Posted

August 14, 2024

Study Start

August 15, 2024

Primary Completion

January 15, 2025

Study Completion

February 15, 2025

Last Updated

August 14, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share