Body Awareness and Functionality in Lymphedema

Lymphedema of Upper Limb Clinical Trial

Official title:

Effects of Lymphedema After Breast Cancer Treatment on Body Awareness and Upper Extremity Functionality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06036173
• Other study ID #: 2023/09.06
• Status: Completed
• Start date: August 16, 2023
• Est. completion date: October 27, 2023

Study information

• Verified date: November 2023
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To determine whether body awareness and upper extremity functionality are affected in patients with or without lymphedema development after breast cancer surgery in comparison with individuals without a history of cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: October 27, 2023
• Est. primary completion date: September 30, 2023
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

first group:

• being female,

• being aged 18-65 years,

• having undergone unilateral breast cancer surgery,

• being diagnosed with secondary lymphedema in the upper extremity according to the International Lymphedema Association

• not having any orthopedic disease that would prevent walking, and volunteering to participate in the study.

second group:The inclusion criteria for the breast cancer surgery group

• without lymphedema were being female,

• being aged 18-65 years,

• having undergone unilateral breast cancer surgery, and volunteering to participate in the study.

Lastly, the inclusion criteria for the control group were:

• being female,

• being aged 18-65 years,

• having no history of cancer surgery, and volunteering to participate in the study.

Exclusion Criteria: for all groups

• not being willing to participate in the study;

• the presence of metastases, neurological, or orthopedic disorders;

• postural deformities, such as scoliosis and kyphosis;

• mental and cognitive disorders; or communication/cooperation problems

Related Conditions & MeSH terms

• Lymphedema
• Lymphedema of Upper Limb

Intervention

Other:
• diagnosis of lymphedema
being diagnosed with secondary lymphedema in the upper extremity according to the International Lymphedema Association
• breast cancer surgery
be diagnosed and undergo surgery

Locations

Country	Name	City	State
Turkey	Selcuk University	Konya	Selcuklu

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Awareness Questionnaire	This instrument consists of a total of 18 items evaluated based on a scale of 1 (not at all true of me) to 7 (very true of me). The total score is obtained by adding the scores of each item. A higher total score indicates better body awareness. Max/ min score:126/18	17 minutes
Primary	Quick-Disabilities of the Arm, Shoulder, and Hand questionnaire	Each of the 11 items in this instrument is scored from 1 to 5. The responses given to all items are summed up, and the total score is obtained with a special formula. A high total score indicates a high level of functional limitation. Max/ min score: 100/0	11 minutes