Clinical trial NCT07013214: Rehabilitation With Dual-task Exercises to Improve Balance in Patients With Parkinson's Disease
Official title: Rehabilitation Program to Improve Balance in Patients With Parkinson's Disease: Dual-Task Exercise - A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease (PD), Postural Balance
Lead sponsor: G. d'Annunzio University
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 criteria: 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.

Primary outcomes:
measure: UPDRS (Unified Parkinson's Disease Rating Scale)
timeFrame: Baseline
measure: Hoehn and Yahr scale
timeFrame: Baseline
measure: MOCA Scale (Montreal Cognitive Assessment)
timeFrame: Baseline
measure: Tinetti Balance and Gait scales
timeFrame: -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion
measure: TUG (Timed Up and Go test)
timeFrame: -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion
Secondary outcomes:
measure: Visual Analogue Scale for pain (VAS)
timeFrame: -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion
measure: TAMPA Scale (Tampa Scale for Kinesiophobia)
timeFrame: -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion
measure: Global Perceived Effect (GPE)
timeFrame: -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion
measure: Barthel Index
timeFrame: -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion
measure: EuroQoL-5D-5L (EuroQoLD5L)
timeFrame: -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion
measure: ABC Scale (Activities-specific Balance Confidence Scale)
timeFrame: -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion
Other outcomes:
Locations:
city: Pescara
country: Italy
facility: Fondazione Paolo Sesto - Centro Adriatico
state: PE
Study officials:
References: