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Rehabilitation With Dual-task Exercises to Improve Balance in Patients With Parkinson's Disease

Rehabilitation With Dual-task Exercises to Improve Balance in Patients With Parkinson's Disease

Recruiting
30 years and older
All
Phase N/A

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Overview

The goal of this clinical trial is to learn if a rehabilitative pathway based on dual-task exercise improves balance in patients with Parkinson's disease, compared to a traditional rehabilitation program. It will also investigate the reduction of fall risk, and improvement in autonomy and quality of life.

The main questions it aims to answer are:

  • Does dual-task exercise improve balance more effectively than traditional rehabilitation in Parkinson's patients?
  • Does dual-task exercise reduce the risk of falls?
  • Does dual-task exercise improve patient autonomy in daily activities?
  • Does dual-task exercise enhance the overall quality of life for Parkinson's patients? Researchers will compare a dual-task exercise program to a standard rehabilitation program. Both groups will receive 20 sessions, 2-3 times a week for two months, each lasting 45 minutes. The study will be double-blinded, meaning neither participants nor researchers involved in treatment administration and data collection will know group assignments. Randomization will be done using dedicated software to ensure unbiased group distribution.

Participants will:

  • Have a confirmed diagnosis of Parkinson's disease (Movement Disorder Society criteria).
  • Be in an early to moderate stage of the disease (Hoehn and Yahr score < 3).
  • Be over 30 years old.
  • Be able to provide informed consent.
  • Have a stable medication regimen for at least three months.

Exclusions include:

  • Hoehn and Yahr score ≥3.
  • Severe cognitive or psychiatric disorders (e.g., dementia).
  • Use of interfering medications or treatments.
  • Participation in other clinical trials.
  • Pregnancy or breastfeeding.
  • Need for medication changes during rehabilitation. Evaluations will be conducted at baseline (T=0), after rehabilitation (T=1), and at a two-month follow-up (T=2). Assessments will include the Tinetti Balance and Gait scales, Timed Up and Go (TUG) test, VAS pain scale, TAMPA Scale for Kinesiophobia, Global Perceived Effect (GPE), Barthel Index, EuroQoL-5D-5L, and ABC Scale. UPDRS, Hoehn and Yahr scale, and MOCA Scale will be administered only at baseline (T=0).

Eligibility

Inclusion Criteria:

  • Confirmed diagnosis of Parkinson's Disease (Movement Disorder Society criteria).
  • Early to moderate stage of the disease (Hoehn and Yahr score < 3).
  • Age over 30 years.
  • Ability to provide informed consent.
  • Stable pharmacological therapy for at least 3 months.

Exclusion Criteria:

  • Hoehn and Yahr score ≥ 3.
  • Severe cognitive or psychiatric disorders (e.g., dementia).
  • Use of interfering medications or treatments.
  • Participation in another clinical trial.
  • Pregnancy or breastfeeding.
  • Need for changes in pharmacological therapy during the rehabilitation period.

Study details
    Parkinson Disease (PD)
    Postural Balance

NCT07013214

G. d'Annunzio University

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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