Effect of Physical Activity on the Course of Parkinson's Disease in Patients With Bilateral DBS-STN Stimulation.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-70
SponsorMedical University of Warsaw
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with idiopathic Parkinson's disease (ICD-10:G20).
Patients qualified for advanced therapies using DBS-STN.
Grade II-IV on the Hoehn & Yahr scale.
Age 50-70.
Disqualifiers
Patients diagnosed with atypical parkinsonism.
Patients not eligible for advanced therapies with DBS-STN.
Hoehn & Yahr Grade I and V.
Age <50 and >70
Trial design
Design model
Parallel
Treatments tested in this trial
Physiotherapy
Procedure/SurgeryAssessment 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.
Education about physiotherapy
BehavioralDirect 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.
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: Research groupExperimental treatment 1 intervention
Group B: Control groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III: Motor Examination
Change in the full Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III: Motor Examination, score in the full ON medication/DBS state from baseline to study completion, comparing the control and study groups, with subsequent study time points also reported. Part III assesses the severity of motor signs of Parkinson's disease. The total score ranges from 0 to 132, with 0 indicating no motor impairment and higher scores indicating greater motor impairment (i.e., a worse outcome).
Time frame
2 yearsSecondary outcomes
1
Tinetti Performance-Oriented Mobility Assessment (POMA)
Change in the full Tinetti Performance-Oriented Mobility Assessment (POMA), also known as the Tinetti Mobility Test, total score in the ON medication/DBS state before and after study completion, comparing the control and research groups, with subsequent study time points also reported. The POMA assesses balance and gait/mobility. The total score ranges from 0 to 28 points (balance: 0-16; gait: 0-12), with higher scores indicating better mobility, gait, and balance function (i.e., a better outcome).
Time frame
2 years2
New Freezing of Gait Questionnaire (NFOG-Q)
Change in the full New Freezing of Gait Questionnaire (NFOG-Q) total score in the ON medication/DBS state before and after study completion, comparing the control and research groups, with subsequent study time points also reported. The NFOG-Q is a patient-reported measure assessing the severity of freezing of gait and its impact on daily life in people with Parkinson's disease. The total score ranges from 0 to 28 points, with 0 indicating no freezing of gait and higher scores indicating greater severity and impact of freezing of gait (i.e., a worse outcome).
Time frame
2 years3
Berg Balance Scale (BBS)
Change in the full Berg Balance Scale (BBS) total score in the ON medication/DBS state before and after study completion, comparing the control and research groups, with subsequent study time points also reported. The BBS is a 14-item performance-based measure of functional balance. Each item is scored from 0 to 4, giving a total score ranging from 0 to 56 points, with higher scores indicating better balance and functional performance (i.e., a better outcome).
Time frame
2 years4
Montreal Cognitive Assessment (MoCA)
Change in the full Montreal Cognitive Assessment (MoCA) total score in the ON medication/DBS state before and after study completion, comparing the control and research groups, with subsequent study time points also reported. The MoCA is a cognitive screening assessment of multiple cognitive domains, including executive function, visuospatial abilities, attention, memory, language, and orientation. The total score ranges from 0 to 30 points, with higher scores indicating better cognitive performance (i.e., a better outcome).
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov