Lymphedema ArmNCT06553183
Immersive Virtual Reality Based Exersice in Post-mastectomy Lymphedema Patients
A study testing immersive virtual reality and traditional physicaltherapy in people with Lymphedema Arm, run by Cairo University.
Trial summary
To determine the effect of immersive virtual reality on shoulder proprioception and ROM of post-mastectomy lymphedema patients. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women only
- Conditions the study is for
- Lymphedema Arm
- What is being tested?
- immersive virtual reality and traditional physicaltherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2024to 15 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All the patients will be females.
- Patients with lymph node dissection.
- start at least 2 weeks after operation.
Who cannot join
- Vision problems.
- Medically instable patients.
- Balance disorders.
- Other musculoskeletal condition of shoulders.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lymphedema Arm
- Being tested
- immersive virtual reality, traditional physicaltherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immersive virtual realityProcedure or surgery
Exercise based on virtual reality video games. Immersive type will be used.
traditional physicaltherapyProcedure or surgery
pneumatic compression, exercise and skin care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: immersive virtual reality; Procedure: traditional physicaltherapy |
| control group | Active comparator | the patients will receive eight sessions of the traditional physical therapy, 2 sessions per week for 4 weeks. Receives: Procedure: traditional physicaltherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
shoulder proprioception
digital goniometer
Measured: 4 weeks
Secondary outcomes (1)
shoulder ROM
all 6 motions will be measured by digital goniometer
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start15 Aug 2024 (estimated)
- Primary completion15 Jan 2025 (estimated)
- Study completion15 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema ArmStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, doaa atef, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553183
- Sponsor's protocol ID
- P.T.REC/012/005255
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immersive Virtual Reality Based Exersice and Shoulder Proprioception and Range of Motion in Post-mastectomy Lymphedema Patients
- ClinicalTrials.gov ID
- NCT06553183
- Acronym / sponsor ID
- P.T.REC/012/005255
- Conditions
- Lymphedema Arm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 15 Feb 2025 (estimated)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effect of immersive virtual reality on shoulder proprioception and ROM of post-mastectomy lymphedema patients.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Procedure: immersive virtual reality, Procedure: traditional physicaltherapythe 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 | Active comparator | Procedure: traditional physicaltherapythe patients will receive eight sessions of the traditional physical therapy, 2 sessions per week for 4 weeks. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All the patients will be females.
- Patients with lymph node dissection.
- start at least 2 weeks after operation.
Key exclusion criteria (4 listed)
- Vision problems.
- Medically instable patients.
- Balance disorders.
- Other musculoskeletal condition of shoulders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immersive virtual realityExercise based on virtual reality video games. Immersive type will be used. | Procedure or surgery | study group |
| traditional physicaltherapypneumatic compression, exercise and skin care | Procedure or surgery | control group, study group |
Primary outcome
shoulder proprioception
Time frame: 4 weeks
digital goniometer
1 secondary outcome
shoulder ROM
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing immersive virtual reality and traditional physicaltherapy in people with Lymphedema Arm, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact doaa atef, PhD (+201060267094 ext. +2, doozy.masr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
shoulder proprioception (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.