Lymphedema of LegNCT06204510
Effects of Complex Decongestive Therapy on Proprioception, Balance and Tactile Sense
A study testing complex decongestive therapy in people with Lymphedema of Leg and Sensitisation, run by Selcuk University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lymphedema of Leg, Sensitisation, Balanced
- What is being tested?
- complex decongestive therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 12 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 18-65
- Having unilateral lymphedema in the lower extremity secondary to cancer surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Selcuk University
Konya, 42130
Emine Cihan, pHd, 5548920407 ext. +90, pteminecihan@gmail.com
About this study
Official title: Effects of Complex Decongestive Therapy on Proprioception, Balance and Tactile Sense in Lymphedema After Cancer Surgery: A Prospective Randomized Controlled Study
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.
- Conditions
- Lymphedema of Leg, Sensitisation, Balanced, Therapy-Associated Cancer
- Being tested
- complex decongestive therapy
- Medical subject headings
- Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
complex decongestive therapyOther
This application consists of manual lymph drainage, skin care, compression bandage and exercises. This phase will continue for 3 weeks, 5 days a week.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Not described |
| study group | Experimental | Not described Receives: Other: complex decongestive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes
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.
Measured: 5 minutes
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
Measured: 5 minutes
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.
Measured: 5 minutes
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Mar 2024
- Primary completion15 Mar 2024
- Study completion12 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphedema of LegStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Cihan, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204510
- Sponsor's protocol ID
- 2023/03.01
- Status last verified
- Mar 2024
- First submitted
- 3 Jan 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cihan E, Pirincci CS. The efficacy of complex decongestive therapy in the treatment of lymphedema associated with endometrial and cervical cancer: evaluation of sensation and balance. Support Care Cancer. 2026 Jan 22;34(2):113. doi: 10.1007/s00520-026-10330-9.
PubMed 41569453
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Complex Decongestive Therapy on Proprioception, Balance and Tactile Sense in Lymphedema After Cancer Surgery: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06204510
- Acronym / sponsor ID
- 2023/03.01
- Conditions
- Lymphedema of Leg, Sensitisation, Balanced, Therapy-Associated Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 12 Apr 2024 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | – |
| study group | Experimental | Other: complex decongestive therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being between the ages of 18-65
- Having unilateral lymphedema in the lower extremity secondary to cancer surgery
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| complex decongestive therapyThis application consists of manual lymph drainage, skin care, compression bandage and exercises. This phase will continue for 3 weeks, 5 days a week. | Other | study group |
Primary outcome
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.
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
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Derived from this study: PubMed 41569453Cihan E, Pirincci CS. The efficacy of complex decongestive therapy in the treatment of lymphedema associated with endometrial and cervical cancer: evaluation of sensation and balance. Support Care Cancer. 2026 Jan 22;34(2):113. doi: 10.1007/s00520-026-10330-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing complex decongestive therapy in people with Lymphedema of Leg and Sensitisation, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emine Cihan, PhD (5548928407 ext. +90, pteminecihan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Proprioception (time frame: 10 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06204510, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.