Parkinson DiseaseEPA-DBSNCT07838636
Effect of Physical Activity on the Course of Parkinson's Disease in Patients With Bilateral DBS-STN Stimulation.
A study testing Physiotherapy and Education about physiotherapy in people with Parkinson Disease and Deep Brain Stimulation, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Parkinson Disease, Deep Brain Stimulation, PD - Parkinson's Disease
- What is being tested?
- Physiotherapy and Education about physiotherapy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 sitePoland
- Study dates
- 5 Sep 2024to 5 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Consent to participate in the study.
Who cannot join
- Patients diagnosed with atypical parkinsonism.
- Patients not eligible for advanced therapies with DBS-STN.
- Hoehn \& Yahr Grade I and V.
- Age <50 and >70
- Patients diagnosed with dementia syndrome (MMSE < 24/30).
- Diseases of the osteoarticular system and muscles that make it impossible to undergo rehabilitation.
- Severe kidney, liver and heart failure.
- Active malignancy or malignancy diagnosed and treated within 3 years prior to the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of Neurology, Faculty of Health Sciences, Bródnowski Mazovian Hospital
Warsaw, 03-242
prof. dr hab. n. med. Dariusz Koziorowski, (0-22) 326 57 44, neurologia@szpital-brodnowski.waw.pl
About this study
Official title: Effect of Physical Activity on the Course of Parkinson's Disease in Patients With Bilateral DBS-STN Stimulation - a Randomized Controlled 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.
- Conditions
- Parkinson Disease, Deep Brain Stimulation, PD - Parkinson's Disease, PD, DBS
- Being tested
- Physiotherapy, Education about physiotherapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyProcedure or surgery
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.
Education about physiotherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Research group | Experimental | Not described Receives: Procedure: Physiotherapy |
| Control group | Sham comparator | Not described Receives: Behavioral: Education about physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 years
Secondary outcomes (4)
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).
Measured: 2 years
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).
Measured: 2 years
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).
Measured: 2 years
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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start5 Sep 2024
- Primary completion5 Sep 2027 (estimated)
- Study completion5 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838636
- Sponsor's protocol ID
- 2024/EL/5418
- Acronym
- EPA-DBS
- Status last verified
- Jun 2026
- First submitted
- 17 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Activity on the Course of Parkinson's Disease in Patients With Bilateral DBS-STN Stimulation - a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07838636
- Acronym / sponsor ID
- EPA-DBS / 2024/EL/5418
- Conditions
- Parkinson Disease, Deep Brain Stimulation, PD - Parkinson's Disease, PD, DBS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 5 Sep 2027 (estimated)
- Study completion
- 5 Sep 2028 (estimated)
- First posted
- 24 Sep 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Research group | Experimental | Procedure: Physiotherapy |
| Control group | Sham comparator | Behavioral: Education about physiotherapy |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Consent to participate in the study.
Key exclusion criteria (8 listed)
- Patients diagnosed with atypical parkinsonism.
- Patients not eligible for advanced therapies with DBS-STN.
- Hoehn \& Yahr Grade I and V.
- Age <50 and >70
- Patients diagnosed with dementia syndrome (MMSE < 24/30).
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 |
|---|---|---|
| PhysiotherapyAssessment 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. | Procedure or surgery | Research group |
| Education about physiotherapyDirect 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. | Behavioural | Control group |
Primary outcome
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III: Motor Examination
Time frame: 2 years
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).
4 secondary outcomes
Tinetti Performance-Oriented Mobility Assessment (POMA)
Time frame: 2 years
New Freezing of Gait Questionnaire (NFOG-Q)
Time frame: 2 years
Berg Balance Scale (BBS)
Time frame: 2 years
Montreal Cognitive Assessment (MoCA)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy and Education about physiotherapy in people with Parkinson Disease and Deep Brain Stimulation, run by Medical University of Warsaw at 1 site in Poland.
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 6 Oct 2026. 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 Poland. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta M Betka, PhD student (48798789277, marta.maria.betka@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III: Motor Examination (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2026.