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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04185181
Other study ID # Doaa Atef
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 30, 2018
Est. completion date August 31, 2019

Study information

Verified date December 2019
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 31, 2019
Est. primary completion date August 5, 2019
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 65 Years
Eligibility 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.

Study Design


Intervention

Other:
virtual reality
wii video game based exercise
proprioceptive neuromuscular facilitation
PNF with breathing
complete decogestive therapy
pneumatic compression, manual lymph drainage, skin care and home exercise program

Locations

Country Name City State
Egypt faculty of physical therapy, Cairo university Giza

Sponsors (1)

Lead Sponsor Collaborator
doaa atef

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary lymphedema volume turncated cone formula using circumferential measurement of both upper limbs 4 weeks
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05726656 - Effect of Wii-console Based Exercise on Shoulder Range of Motion for Post-mastectomy Lymphedema Patients N/A
Active, not recruiting NCT05441943 - Lymphaticovenous Anastomosis as Treatment for Lymphedema N/A