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RecruitingNCT07838636EPA-DBSUpdated Oct 6, 2026

Effect of Physical Activity on the Course of Parkinson's Disease in Patients With Bilateral DBS-STN Stimulation.

An interventional study of Physiotherapy and Education about physiotherapy in Parkinson Disease, Deep Brain Stimulation and PD - Parkinson's Disease, sponsored by Medical University of Warsaw. Recruiting at 1 site in Poland. Open to participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Medical University of Warsaw · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Sep 2024, registered Sep 2026).
  • Started Sep 2024; still recruiting 2 years 2 months later.
Updated Oct 6, 2026Primary outcomes revisedTitle changedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
50 Years to 70 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Parkinson Disease
  • Deep Brain Stimulation
  • PD - Parkinson's Disease
  • PD
  • DBS

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03

In context

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

This study's planned enrollment of 102 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Medical University of Warsaw is the lead sponsor of 326 studies on the registry; 87 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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 ( \< 24/30).
  • Diseases of the osteoarticular system and muscles that make it impossible to undergo rehabilitation.
  • Severe kidney, liver and heart failure.
  • Active or malignancy diagnosed and treated within 3 years prior to the study.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
102 participants (estimated)

Study arms

  • Experimental
    Research group

    Procedure: Physiotherapy

  • Sham comparator
    Control group

    Behavioral: Education about physiotherapy

Interventions

  • ProcedurePhysiotherapy

    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.

  • BehavioralEducation about physiotherapy

    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.

06

What researchers measure

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 years

Secondary 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 years

  2. 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 years

  3. 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 years

  4. 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 years

07

Study locations

1 of 1 sites recruiting
  • Department of Neurology, Faculty of Health Sciences, Bródnowski Mazovian Hospital
    Warsaw, 03-242, Poland
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • ChangedBefore Part III UPDRS-MDSNow Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III: Motor ExaminationTime frame: 2 years
Oct 6, 2026
Secondary outcomes
1 edited, 3 added, 3 removed
What changed in the outcomes
  • EditedBerg Balance Scale (BBS)Time frame: 2 years
  • AddedTinetti Performance-Oriented Mobility Assessment (POMA)Time frame: 2 years
  • AddedNew Freezing of Gait Questionnaire (NFOG-Q)Time frame: 2 years
  • AddedMontreal Cognitive Assessment (MoCA)Time frame: 2 years
  • RemovedTinetti ScaleTime frame: 2 years
  • RemovedNFOG-QTime frame: 2 years
  • RemovedMoCA ScaleTime frame: 2 years
Oct 6, 2026
Title
Effect of Physical Activity on the Course of Parkinson's Disease in Patients With Bilateral DBS-STN Stimulation - a Randomized Controlled Trial.
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Primary outcomes 1 edited
    What changed in the outcomes
    • ChangedBefore Part III UPDRS-MDSNow Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III: Motor ExaminationTime frame: 2 years
    Secondary outcomes 1 edited, 3 added, 3 removed
    What changed in the outcomes
    • EditedBerg Balance Scale (BBS)Time frame: 2 years
    • AddedTinetti Performance-Oriented Mobility Assessment (POMA)Time frame: 2 years
    • AddedNew Freezing of Gait Questionnaire (NFOG-Q)Time frame: 2 years
    • AddedMontreal Cognitive Assessment (MoCA)Time frame: 2 years
    • RemovedTinetti ScaleTime frame: 2 years
    • RemovedNFOG-QTime frame: 2 years
    • RemovedMoCA ScaleTime frame: 2 years
    Title Effect of Physical Activity on the Course of Parkinson's Disease in Patients With Bilateral DBS-STN Stimulation - a Randomized Controlled Trial.

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07838636
Responsible party
Sponsor
First posted
Sep 24, 2026
Start date
Sep 5, 2024
Primary completion
Sep 5, 2027 (estimated)
Completion
Sep 5, 2028 (estimated)
Last update
Oct 6, 2026

Study contacts

Marta M Betka, PhD student
Contact
marta.maria.betka@gmail.com
48798789277

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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