NCT04185181

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 30, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2019

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
Last Updated

December 5, 2019

Status Verified

December 1, 2019

Enrollment Period

1.1 years

First QC Date

November 26, 2019

Last Update Submit

December 3, 2019

Conditions

Postmastectomy Lymphedema

Outcome Measures

Primary Outcomes (2)

  • lymphedema volume

    turncated cone formula using circumferential measurement of both upper limbs

    4 weeks

  • 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.

    4 weeks

Study Arms (2)

virtual reality

ACTIVE COMPARATOR
Other: virtual realityOther: complete decogestive therapy

propreoceptive neuromuscular facilitation

ACTIVE COMPARATOR
Other: proprioceptive neuromuscular facilitationOther: complete decogestive therapy

Interventions

virtual realityOTHER

wii video game based exercise

virtual reality
proprioceptive neuromuscular facilitationOTHER

PNF with breathing

propreoceptive neuromuscular facilitation
complete decogestive therapyOTHER

pneumatic compression, manual lymph drainage, skin care and home exercise program

propreoceptive neuromuscular facilitationvirtual reality

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy, Cairo university

Giza, 11432, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 32537717DERIVED

MeSH Terms

Conditions

Breast Cancer Lymphedema

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

LymphedemaLymphatic DiseasesHemic and Lymphatic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • doaa AA abd-el-wahed, A.lecturer

    assistant lecturer at faculty of physical therapy, Cairo university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant lecturer of physical therapy for surgery

Study Record Dates

First Submitted

November 26, 2019

First Posted

December 4, 2019

Study Start

June 30, 2018

Primary Completion

August 5, 2019

Study Completion

August 31, 2019

Last Updated

December 5, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)