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NCT Number: NCT07838636

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.

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Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, Faculty of Health Sciences, Bródnowski Mazovian Hospital

Warsaw, 03-242, Poland

Location status: Recruiting

Location contact

prof. dr hab. n. med. Dariusz Koziorowski

CONTACT

[email protected]

(0-22) 326 57 44

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

physiotherapy

Procedure

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 physiotherapy

Behavioral

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.

Primary outcomes

  1. Part III UPDRS-MDS

    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.

Secondary outcomes

  1. Tinetti Scale

    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.

  2. NFOG-Q

    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.

  3. Berg Balance Scale

    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.

  4. MoCA Scale

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marta M Betka, PhD student

CONTACT

[email protected]

48798789277

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Acronym: EPA-DBS

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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