Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545383
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-04
Brief Title:
The Effect of Dynamic Neuromuscular Stabilization Exercises in Patients With Lower Extremity Lymphedema
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Dynamic Neuromuscular Stabilization Exercises on Balance Proprioception and Functional Level in Patients With Lower Extremity Lymphedema
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
After lower extremity lymphedema individuals physical activity levels and functionality remain very low This decrease can cause balance problems over time Surgical and medical treatments reduce the nerve conduction efficiency of the nervous system and negatively affect proprioception which is the perception of the joints position in space during movement Increasing errors in joint position sense reduce control of movement and restrict active movement which lead to an assumption that balance could be affected Joint position sense and balance may be negatively affected causing injuries and injuries may cause damage to ligaments and sensory nerve fibers The main aim of the Dynamic Neuromuscular Stabilization DNS approach is to restore physiological movement patterns By activating the deep stabilizer system with DNS exercises joint movements could improved and exercise positions will have positive effects on the quality of sensory perception In addition positive effects on balance are expected due to decrease in joint position sense errors Therefore the aim of the study is to investigateunderstand the effect of DNS exercises on balance proprioception and functional level in patients with lower extremity lymphedema This study will provide information for researchers therapists and patients by determining the effectiveness of DNS exercises in patients with lower extremity lymphedema
from Bezmiâlem Vakıf University Faculty of Medicine Department of Physical Therapy and Rehabilitation who have been diagnosed with lymphedema due to primary or secondary causes and have progressed to the Complex Decongestive Treatment Phase 2 will constitute the population of the study The study will be carried out at Istanbul University-Cerrahpaşa Department of Physiotherapy and Rehabilitation
The study will consist of two groups Both groups will be included in an exercise program consisting of breathing exercises active joint range of motion exercises and walking training Exercises will be given as a home program for 6 weeks 3 days a week 45 minutes a day Additionally patients in the Control group will be asked to walk for 40 minutes 2 days a week for 6 weeks In the intervention group they will additionally be included in a program consisting of individualized DNS exercises for 40 minutes a day 2 days a week for 6 weeks All patients will be asked to wear compression garments during exercises
from Bezmiâlem Vakıf University Faculty of Medicine Department of Physical Therapy and Rehabilitation who have been diagnosed with lymphedema due to primary or secondary causes and have progressed to the Complex Decongestive Treatment Phase 2 will constitute the population of the study The study will be carried out at Istanbul University-Cerrahpaşa Department of Physiotherapy and Rehabilitation
The study will consist of two groups Both groups will be included in an exercise program consisting of breathing exercises active joint range of motion exercises and walking training Exercises will be given as a home program for 6 weeks 3 days a week 45 minutes a day Additionally patients in the Control group will be asked to walk for 40 minutes 2 days a week for 6 weeks In the intervention group they will additionally be included in a program consisting of individualized DNS exercises for 40 minutes a day 2 days a week for 6 weeks All patients will be asked to wear compression garments during exercises
Detailed Description:
The study will be carried out with 42 cases referred from Bezmialem Vakif University Faculty of Medicine Hospital Physical Therapy and Rehabilitation Clinic It will be carried out at Istanbul University-Cerrahpasa Department of Physiotherapy and Rehabilitation Patients will be randomly divided into Intervention and Control groups Both groups will be included in an exercise program consisting of breathing exercises that stimulate the lymphatic system in the thoracic region active joint range of motion exercises and walking training to increase muscle strength and endurance Exercises will be given as a home program for 6 weeks 3 days a week 45 minutes a day Additionally patients in the Control Group will be asked to walk for 40 minutes 2 days a week for 6 weeks In the Intervention Group they will additionally be included in a program consisting of different postural positions and individualized Dynamic Neuromuscular Stabilization DNS exercises added while maintaining the position 2 days a week 40 minutes a day for 6 weeks All patients will be asked to wear compression garments during exercises Patients demographic information age height weight dominant extremity occupation and education level duration years and stage of lymphedema complaints and medical history chemotherapy radiotherapy and surgical treatment will be questioned Participants lower extremity edema will be evaluated with a tape measure Their static balance will be evaluated by the one-leg standing test their dynamic balance by the Y balance test and their proprioception sense by the joint position sense test The functional levels of the patients will be evaluated using the 10-meter walk test and the Lower Extremity Functional Scale Additionally individuals fear of falling will be questioned with the International Fall Activity Scale All evaluations will be made before treatment and after the 6th week of treatment is completed The sample size was calculated with the G Power 31 power analysis program Considering the effect size of edema evaluation which is one of the outcome measurements as 090 the sample size required for a 95 study power was calculated with a 95 confidence interval It was determined that the number of cases to be included in each group was at least 19 In order to preserve the 95 study power against the possibility of cases falling out of the study 21 cases will be included by adding a 10 drop margin to each group Statistical analysis of the data obtained from the study Statistical Package for Social Sciences SPSS Version 220 SPSS inc Chicago USA statistical program Whether the data conforms to normal distribution will be determined by the Shapiro-Wilk Test According to the analysis results of this test parametric tests will be applied in the analysis of data that conforms to normal distribution and non -parametric tests will be applied in the analysis of data that does not comply with normal distribution In the statistical analysis of the study the variables evaluated will be defined with mean Mean standard deviation SD and percentage values For quantitativenumerical data comparing the demographic and clinical characteristics of the groups that make up the study Independent Samples T-test and Chi-square test will be used for qualitativenon-numerical data Results will be considered significant at the 95 confidence interval and significance level of p005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None