Clinical Trials Logo

Clinical Trial Summary

Parkinson's disease (PD) is the second most common progressive disease after Alzheimer's disease.It is a progressive, multisystemic and neurodegenerative disease. The prevalence of Parkinson's disease increases with age. increases together. In industrialized countries, people over the age of 60 account for 0.3% of the entire population.It affects about 1% of people and 3% of people over the age of 80 .Patient management with telerehabilitation (TR), chronic heart disease, neurological dysfunction.It is as effective as face-to-face treatment in different clinical conditions such as musculoskeletal and musculoskeletal disorders proven . In addition, TR will increase accessibility and create a less restrictive environment. comparable to traditional rehabilitation as it provides new opportunities to create not only can it be more effective than it . Intense exercise and long-term training In cases where it is necessary, it is accepted to continue exercise therapy with TR programs at home.may be a viable solution.When telerehabilitation-based studies are examined, communication, swallowing and walking are generally focused on parameters. Treatment with telerehabilitation method in PD, Studies investigating the effects on respiratory and postural instability parameters are quite is limited . The aim of this study is to improve telerehabilitation-based exercise training in PD. respiratory muscle strength, cough capacity, dynamic balance, participation in activities of daily living and to investigate its effect on walking parameters. also online physiotherapist.Comparing the effects of supervised exercises and offline video-based exercise training intended.


Clinical Trial Description

Parkinson disease (PD) is the most common progressive, multisystemic and neurodegenerative disease after Alzheimer disease. Its prevalence increases with age and rises sharply around the age of 65 . The main pathological change is the progressive degeneration of neurons in the substantia nigra pars compacta, one of the nuclei forming then basal ganglia . Currently, pharmacological treatments are used primarily for symptomatic control and provide only short-term benefits before the disease progresses to a severe stage. Physical activity and exercise can provide cost-effective and universally available aids for current PH treatments. Therefore, it is imperative to examine the effects of exercise on PD. Evidence shows that exercise training is an effective approach to manage symptoms in PD . Physiotherapy interventions in PD aim to maximize functional ability and minimize secondary complications within the scope of patient education and rehabilitation support, and to control unwanted side effects of medical treatment and possible motor fluctuations . Patients who applied to the Neurology Clinic of Bakirkoy Psychiatric and Neurological Diseases Hospital and were diagnosed with idiopathic PH and volunteered to participate in the study will be included in our study. Patients with PD who meet the study inclusion criteria and are between the ages of 50-85 years according to Modified Hoehn & Yahr will be randomly assigned to the intervention and control groups. Patients with PH participating in the study will be randomly assigned to the intervention (Online) and control (Offline) groups. Patients in both groups will participate in a telerehabilitation-based exercise program for 45-60 minutes a day, 3 days a week, for 6 weeks. The intensity of exercise training will be planned to progress gradually every two weeks. In the following weeks, the number of repetitions, the number of sets and the difficulty levels of the exercises will be increased compared to the beginning and the exercises will be continued. Trainings for intervention group patients will be performed by researchers under the supervision of a physiotherapist through an online platform on breathing, balance and strengthening exercises suitable for the patients. For the patients in the control group, the same exercises will be recorded on video every two weeks and the exercise program of each week will be sent to the patient. The patient will be asked to do the exercises accompanied by video. The general evaluation form of the patients and their demographic information, disease history, family history, contact information, education level, and medications will be questioned. Modified Hoehn-Yahr Score and Unified Parkinson Disease Rating Scale (UPDRS) will be used to evaluate disease severity and disability level.Respiratory muscle strength of the patients will be measured using a portable, electronic intraoral pressure measuring device (Carefusion Micromedical, Micro RPM, USA). Peak cough flow will be measured with PEF (peak flow meter).Balance will be evaluated with the Tinetti Balance Scale and the Timed Get Up and Go Test. The 10 m walking test will be used to evaluate walking performance. Participation in activities of daily living and evaluation of patients functional activity status will be performed with the Parkinson Activity Scale . The sample size of the study was calculated with the G*Power 3.1 power analysis program. Considering the effect size of the Timed Up and Go Test, one of the outcome measurements,1.48, the sample size required for 99% working power was calculated at a 95% confidence interval. It was determined that the number of cases to be included for both groups should be at least 19. In order to protect the working power of the cases against the possibility of dropping out of the study, a 10% drop rate will be added to each group and 21 cases will be included . Statistical analysis of the data obtained from the study will be made using the statistical program "Statistical Package for Social Sciences" (SPSS) Version 22.0 (SPSS inc., Chicago, IL, USA). Whether the data are suitable for 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 the data that fit the normal distribution, and non-parametric tests will be used in the analysis of the data that do not fit the normal distribution. In the statistical analysis of the study, the evaluated variables will be defined with mean (Mean), standard deviation (SD), confidence interval (CI) and percentage values. Independent Samples T-test for quantitative/numerical data and Chi-squared test for qualitative/non-numerical data will be used to compare the demographic and clinical characteristics of the groups that make up the study. Comparison of the pre-treatment and post-treatment values of the groups will be made with Wilcoxon Signed Rank test or Paired Samples T-test. Comparison of data between groups will be done with Mann Whitney U test or Independent Samples T-test. Effect size of changes within groups, difference between measurements. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05621642
Study type Interventional
Source Istanbul University-Cerrahpasa
Contact Rüstem Mustafaoglu
Phone 05554178535
Email rustem.mustafaoglu@iuc.edu.tr
Status Not yet recruiting
Phase N/A
Start date November 20, 2022
Completion date June 5, 2023

See also
  Status Clinical Trial Phase
Completed NCT05415774 - Combined Deep Brain Stimulation in Parkinson's Disease N/A
Recruiting NCT04691661 - Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease Phase 2
Active, not recruiting NCT05754086 - A Multidimensional Study on Articulation Deficits in Parkinsons Disease
Completed NCT04045925 - Feasibility Study of the Taïso Practice in Parkinson's Disease N/A
Recruiting NCT04194762 - PARK-FIT. Treadmill vs Cycling in Parkinson´s Disease. Definition of the Most Effective Model in Gait Reeducation N/A
Completed NCT02705755 - TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH) Phase 2
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT05830253 - Free-living Monitoring of Parkinson's Disease Using Smart Objects
Recruiting NCT03272230 - Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System N/A
Recruiting NCT06139965 - Validity and Reliability of the Turkish Version of the Comprehensive Coordination Scale in Parkinson's Patients
Completed NCT04580849 - Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease N/A
Completed NCT03980418 - Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam N/A
Completed NCT04477161 - Effect of Ketone Esters in Parkinson's Disease N/A
Completed NCT04942392 - Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic N/A
Terminated NCT03446833 - LFP Beta aDBS Feasibility Study N/A
Completed NCT03497884 - Individualized Precise Localization of rTMS on Primary Motor Area N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Recruiting NCT04997642 - Parkinson's Disease and Movement Disorders Clinical Database
Completed NCT04117737 - A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson N/A
Recruiting NCT03618901 - Rock Steady Boxing vs. Sensory Attention Focused Exercise N/A