Department of Neurology, Faculty of Health Sciences, Bródnowski Mazovian Hospital
Warsaw, 03-242, Poland
Location status: Recruiting
NCT Number: NCT07838636
Parkinson's disease is a common, progressive neurodegenerative disorder. The degeneration of dopaminergic neurons is associated with characteristic clinical symptoms such as tremor, rigidity, slowness of movement (bradykinesia) and postural instability. Subthalamic nucleus deep brain stimulation (DBS-STN) is a recognized and widely used method of treating advanced stages of Parkinson's disease. It improves clinical symptoms such as tremor, rigidity and slowness of movement (bradykinesia). This method has limited application for late motor and non-motor symptoms such as: akinesia, postural instability, gait, including the phenomenon of "freezing", recurrent falls, balance and dysarthria. These symptoms reduce the quality of life of patients and make them dependent on their caregivers. There is a clear need to develop additional forms of therapy that complement deep brain stimulation in controlling late motor and non-motor symptoms.
Physical activity is a commonly used and recommended form of therapy for patients with Parkinson's disease and a complement to pharmacological therapy, improving gait, balance and quality of life. However, there are no clear recommendations including patients after implantation of DBS-STN stimulators to the group undergoing physiotherapy. To this day, only one clinical trial has been registered assessing the effect of physiotherapy on balance and gait in patients with DBS-STN.
Interested in participating?
Request Info50 year–70 year
All sexes
Interventional
Not applicable
Warsaw, 03-242, Poland
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Assessment of the patient's functional status: 10 Meter Walk (10 MW) Test, Tinetti Test, New Freezing of Gait Questionnaire (NFOG-Q), History of Falling Questionaire, Timed up and go (TUG), TUG - countdown from 100 to 80, TUG - cup half-filled with water carried in the right and left hand, TST - 10 s standing in a tandem position, 180 Tandem Pivot Test, TWT - Tandem Walking Test, Functional Reach test, Functional strength test, TEST Six Minute Walk (6MWT), Berg Balance Scale, Treadmill Gait Analysis, Platform Stabilometry Test.
Direct education of the patient in the field of self-care, counseling and instruction on independent exercise, use of medical equipment or devices, also at home.
Time frame: 2 years
Change in full ON-state score (Drugs+DBS) in Part III of the UPDRS-MDS Scale before and after study completion in control vs. study and subsequent study time points.
Time frame: 2 years
Change in full ON-state score (Drugs+DBS) in Tinetii Scale before and after study completion in control vs. research group and subsequent study time points.
Time frame: 2 years
Change in full ON-state score (Drugs+DBS) in New Freezing of Gait Questionaire before and after study completion in control vs. research group and subsequent study time points.
Time frame: 2 years
Change in full ON-state score (Drugs+DBS) in Berg Balance Scale before and after study completion in control vs. research group and subsequent study time points.
Time frame: 2 years
Change in full ON-state score (Drugs+DBS) in MoCA Scale before and after study completion in control vs. research group and subsequent study time points.
Contact information is provided by the study sponsor or research team.
Medical University of Warsaw
Other
Acronym: EPA-DBS
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