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

NCT07838636 | Recruiting

• 1 other identifier: 2024/EL/5418
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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.

  2 years

Secondary Outcomes (4)

• Tinetti Scale

  2 years

• NFOG-Q

  2 years

• Berg Balance Scale

  2 years

• MoCA Scale

  2 years

Study Arms (2)

Research group

EXPERIMENTAL

Procedure: Physiotherapy

Control group

SHAM COMPARATOR

Behavioral: Education about physiotherapy

Interventions

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.

Research group

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.

Control group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

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

Warsaw, 03-242, Poland

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Central Study Contacts

Marta M Betka, PhD student

CONTACT

48798789277; marta.maria.betka@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 24, 2026
• Study Start: September 5, 2024
• Primary Completion (Estimated): September 5, 2027
• Study Completion (Estimated): September 5, 2028
• Last Updated: September 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)