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RecruitingNCT07838636EPA-DBSUpdated Sep 24, 2026

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

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 2026-09-24.

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

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

Who can participate

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

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 (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.
04

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.

05

What researchers measure

Primary outcomes

  1. Part III UPDRS-MDS

    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

Secondary outcomes

  1. Tinetti Scale

    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

  2. NFOG-Q

    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

  3. Berg Balance Scale

    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

  4. MoCA Scale

    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.

    Time frame: 2 years

06

Study locations

1 of 1 sites recruiting
  • Department of Neurology, Faculty of Health Sciences, Bródnowski Mazovian Hospital
    Warsaw, 03-242, Poland
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07838636
Lead sponsor
Medical University of Warsaw
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
Sep 24, 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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