Back to resultsVirtual Reality Versus Proprioceptive Neuromuscular Facilitation on Postmastectomy Lymphedema
Primary Purpose
Postmastectomy Lymphedema
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
virtual reality
proprioceptive neuromuscular facilitation
complete decogestive therapy
Sponsored by
About this trial
This is an interventional treatment trial for Postmastectomy Lymphedema
Eligibility Criteria
Inclusion Criteria:
- Patients will suffer from unilateral post-mastectomy lymphedema.
- Stage I and stage II lymphedema as defined by the classification of the International Society of Lymphology (The International Society of Lymphology, 2003).
- Patients had no physical therapy before the current treatment or the last time to receive sessions was at least three months ago.
Exclusion Criteria:
- Excluded patients were having musculoskeletal or neurological disorders that would impair performance during training and tests.
- Visual disorders that could affect imitation of video game-based exercise.
- Uncontrolled cardiovascular or pulmonary diseases.
- Psychiatric illness, severe behavior, and cognitive disorders.
Sites / Locations
- faculty of physical therapy, Cairo university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
virtual reality
propreoceptive neuromuscular facilitation
Arm Description
Outcomes
Primary Outcome Measures
lymphedema volume
turncated cone formula using circumferential measurement of both upper limbs
upper limb function
quick-disability of arm, shoulder and hand (DASH) scale. minimum score is zero and maximum score is 44. higher score means worse outcome.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04185181
Brief Title
Virtual Reality Versus Proprioceptive Neuromuscular Facilitation on Postmastectomy Lymphedema
Official Title
Virtual Reality Versus Proprioceptive Neuromuscular Facilitation on Postmastectomy Lymphedema
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
June 30, 2018 (Actual)
Primary Completion Date
August 5, 2019 (Actual)
Study Completion Date
August 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
doaa atef
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
This study aimed to compare the therapeutic efficacy of VR and PNF on lymphedema and function in unilateral post-mastectomy lymphedema (UPML) patients. The patients were subdivided into two equal groups, 15 in each. Fifteen patients performed virtual reality-based exercises plus complete decongestive therapy, while the other fifteen patients performed proprioceptive neuromuscular facilitation plus complete decongestive therapy. The volume difference between normal and affected limbs was calculated before and after eight sessions of treatment for both groups by using the circumferential method. And the upper limb function was assessed before and after eight sessions of treatment for both groups by using the Arabic version of the Quick DASH scale.
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
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
virtual reality
Arm Type
Active Comparator
Arm Title
propreoceptive neuromuscular facilitation
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
virtual reality
Intervention Description
wii video game based exercise
Intervention Type
Other
Intervention Name(s)
proprioceptive neuromuscular facilitation
Intervention Description
PNF with breathing
Intervention Type
Other
Intervention Name(s)
complete decogestive therapy
Intervention Description
pneumatic compression, manual lymph drainage, skin care and home exercise program
Primary Outcome Measure Information:
Title
lymphedema volume
Description
turncated cone formula using circumferential measurement of both upper limbs
Time Frame
4 weeks
Title
upper limb function
Description
quick-disability of arm, shoulder and hand (DASH) scale. minimum score is zero and maximum score is 44. higher score means worse outcome.
Time Frame
4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients will suffer from unilateral post-mastectomy lymphedema.
Stage I and stage II lymphedema as defined by the classification of the International Society of Lymphology (The International Society of Lymphology, 2003).
Patients had no physical therapy before the current treatment or the last time to receive sessions was at least three months ago.
Exclusion Criteria:
Excluded patients were having musculoskeletal or neurological disorders that would impair performance during training and tests.
Visual disorders that could affect imitation of video game-based exercise.
Uncontrolled cardiovascular or pulmonary diseases.
Psychiatric illness, severe behavior, and cognitive disorders.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
doaa AA abd-el-wahed, A.lecturer
Organizational Affiliation
assistant lecturer at faculty of physical therapy, Cairo university
Official's Role
Principal Investigator
Facility Information:
Facility Name
faculty of physical therapy, Cairo university
City
Giza
ZIP/Postal Code
11432
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32537717
Citation
Atef D, Elkeblawy MM, El-Sebaie A, Abouelnaga WAI. A quasi-randomized clinical trial: virtual reality versus proprioceptive neuromuscular facilitation for postmastectomy lymphedema. J Egypt Natl Canc Inst. 2020 Jun 15;32(1):29. doi: 10.1186/s43046-020-00041-5.
Results Reference
derived
Learn more about this trial
Virtual Reality Versus Proprioceptive Neuromuscular Facilitation on Postmastectomy Lymphedema
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