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Clinical Trials/NCT06204510
NCT06204510RecruitingNot Applicable

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

Selcuk University2 sites in 2 countries40 target enrollmentStarted: March 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
40
Locations
2
Primary Endpoint
Evaluation of Proprioception

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

study group

Experimental

Intervention: complex decongestive therapy (Other)

control group

No Intervention

Outcomes

Primary Outcomes

Evaluation of Proprioception

Time Frame: 10 minutes

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.

Two Point Discrimination

Time Frame: 5 minutes

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.

Softt Touch Sense

Time Frame: 5 minutes

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.

One-leg Standing Test

Time Frame: 5 minutes

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.

30 Seconds Sit-Stand-on-Chair Test:

Time Frame: 5 minutes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Emine Cihan

Assistant Prof.

Selcuk University

Study Sites (2)

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