Effects of Complex Decongestive Therapy on Proprioception, Balance and Tactile Sense

Lymphedema of Leg Clinical Trial

Official title:

Effects of Complex Decongestive Therapy on Proprioception, Balance and Tactile Sense in Lymphedema After Cancer Surgery: A Prospective Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06204510
• Other study ID #: 2023/03.01
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: April 12, 2024

Study information

• Verified date: March 2024
• Source: Selcuk University
• Contact: Emine Cihan, PhD
• Phone: 5548928407
• Email: pteminecihan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the effects of complex decongestive physiotherapy (CDP) on propriseception, balance and sensation in patients with secondary lymphedema that develops in the lower extremities after cancer surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 12, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Being between the ages of 18-65
• Having unilateral lymphedema in the lower extremity secondary to cancer surgery

Exclusion Criteria:

• Having bilateral lower extremity lymphedema
• Having an active infection
• Having a mental cognitive disorder
• Being at a level where communication and cooperation cannot be established
• Situations where manual lymphatic drainage is contraindicated (such as severe heart failure and/or uncontrolled rhythm disorder, uncontrolled hypertension, pregnancy, presence of thrombus, active infection)
• Presence of metastasis

Related Conditions & MeSH terms

• Lymphedema
• Lymphedema of Leg
• Neoplasms, Second Primary
• Sensitisation
• Therapy-Associated Cancer

Intervention

Other:
• complex decongestive therapy
This application consists of manual lymph drainage, skin care, compression bandage and exercises. This phase will continue for 3 weeks, 5 days a week.

Locations

Country	Name	City	State
Turkey	Selcuk University	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Proprioception	Joint position sense: While the patient lies in the prone position, 15-45-60 degrees of knee flexion will be evaluated in 2 different ways: eyes open and eyes closed. Participants will be asked to find the target angle they have been taught with their eyes closed and will be asked to say "here" in the position where they think they have reached the target angle.	10 minutes
Primary	One-leg Standing Test	It is performed with one leg supported to evaluate static balance. The eyes will be fixed in the direction of the head and the participant will be asked to close their eyes and will be expected to maintain balance for 30 seconds. It ends when the balance is disrupted. The test will be terminated when the maximum time of 30 seconds expires.	5 minutes
Primary	30 Seconds Sit-Stand-on-Chair Test:	In the application of the test, the participant will be asked to sit in the middle part of a 43.18 cm (12 inches) high chair with his back upright, his feet on the ground and his arms crossed in front of his body. While in this position, the test started with the "start" command and the participant will be asked to stand up and sit down as fully as he can for 30 seconds. Standing upright once will count as 1, and the number of times he stands upright during 30 seconds will constitute the participant's score	5 minutes
Primary	Softt Touch Sense	It is evaluated with Semmes Weinstein Monofilaments (SWM). The test will be performed with the patient lying in the supine position. In practice, the areas to be tested will be determined as the 1st metatarsal and 5th metatarsal heads and the midpoint of the heel. Values between 1.65-2.83 (green) are considered normal sensation. Values between 3.22-3.61 (blue) are reduced light touch, values between 3.84-4.31 (purple) are reduced protective sensation, values between 4.56-6.65 (red) are loss of protective sensation and 6, If there is no response to 65, it is considered deep pressure perception.	5 minutes
Primary	Two Point Discrimination	Participants will be evaluated in a sitting position with eyes closed using an aesthesiometer (Instrument Company, Lafayette, IN, USA). The evaluation will be made from the trans-metatarsal area, the middle of the foot and the middle of the heel. It will start from the range where the two points can be easily distinguished. The shortest length felt between two points will give the static two-point discrimination value.	5 minutes