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Completed

NCT Number: NCT07013214

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

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).

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Paolo Sesto - Centro Adriatico

Pescara, PE, 65126, Italy

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Dual-Task Exercise

Behavioral

This intervention consists of exercises that integrate motor tasks (e.g., balance training, walking) with concurrent cognitive tasks (e.g., counting, verbal fluency, decision-making tasks). The progression of exercises will be tailored to the individual's abilities, gradually increasing the difficulty of both the motor and cognitive components.

standard rehabilitation

Behavioral

This intervention consists of conventional exercises aimed at improving balance, gait, posture, and flexibility, without the integration of simultaneous cognitive tasks. The program will focus on established physical therapy techniques for Parkinson's disease.

Primary outcomes

  1. UPDRS (Unified Parkinson's Disease Rating Scale)

    Time frame: Baseline

    It is a widely used scale to assess the severity of symptoms in patients with Parkinson's disease. It consists of four sections: non-motor and mental aspects, motor aspects, motor complications, and treatment. It evaluates aspects such as tremor, rigidity, bradykinesia, balance, and daily activities.

  2. Hoehn and Yahr scale

    Time frame: Baseline

    It is a staging scale that classifies the severity of Parkinson's disease into five stages, from mild (stage 1) to severe (stage 5), based on the presence of motor symptoms and functional impairment.

  3. MOCA Scale (Montreal Cognitive Assessment)

    Time frame: Baseline

    The MoCA is a screening tool used to assess cognitive functions. It is designed to detect mild and moderate cognitive impairments, such as those associated with dementia or other neurological conditions. The scale covers various cognitive domains, including attention, concentration, memory, language, visuospatial abilities, abstraction, calculation, and orientation. The maximum score is 30 points, and a score below 26 may indicate the presence of cognitive impairment.

  4. Tinetti Balance and Gait scales

    Time frame: -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion

    Two distinct but related scales:

    • Tinetti Balance Scale: assesses fall risk through various balance tests.
    • Tinetti Gait Scale: evaluates gait and the related risk of falling. Both scales are used to identify individuals at risk of falling and to monitor the effectiveness of interventions.
  5. TUG (Timed Up and Go test)

    Time frame: -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion

    It is a simple test that measures the time a person takes to stand up from a chair, walk three meters, turn around, return, and sit down. It is used to assess balance and fall risk.

Secondary outcomes

  1. Visual Analogue Scale for pain (VAS)

    Time frame: -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion

    It is a subjective scale that allows patients to rate their level of pain on a 10 cm line, where 0 indicates no pain and 10 indicates the worst imaginable pain.

  2. TAMPA Scale (Tampa Scale for Kinesiophobia)

    Time frame: -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion

    It assesses the fear of movement or reactivation due to pain or risk of injury. It consists of questions that measure the fear of moving and becoming active again.

  3. Global Perceived Effect (GPE)

    Time frame: -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion

    It is a subjective scale used to assess a patient's overall perception of improvement or worsening after an intervention or treatment. A 7-point scale is typically used, where the patient indicates whether they feel much improved, improved, unchanged, worsened, or much worsened. It is a simple and quick tool to obtain a global assessment of the perceived effectiveness of the treatment.

  4. Barthel Index

    Time frame: -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion

    It is a scale used to assess the level of independence in activities of daily living (ADLs). It includes 10 items covering activities such as eating, dressing, personal hygiene, mobility, using the toilet, continence, and walking or moving around. Each activity is scored, contributing to a total maximum score of 100, where a higher score indicates greater independence.

  5. EuroQoL-5D-5L (EuroQoLD5L)

    Time frame: -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion

    It is a tool used to assess health-related quality of life. It includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity, ranging from no problems to extreme problems. In addition, it includes a visual analogue scale (VAS) where the patient rates their overall health on a scale from 0 to 100. It is widely used in clinical research and public health assessments.

  6. ABC Scale (Activities-specific Balance Confidence Scale)

    Time frame: -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion

    It measures the patient's confidence in their ability to maintain balance during various daily activities. It consists of 16 items, each rated on a scale from 0% (no confidence) to 100% (complete confidence). It is particularly useful for assessing fall risk and the effectiveness of rehabilitation interventions aimed at improving balance and safety in daily activities.

Sponsors and collaborators

Lead sponsor

G. d'Annunzio University

Other

Registry information

Official study title

Rehabilitation Program to Improve Balance in Patients With Parkinson's Disease: Dual-Task Exercise - A Randomized Controlled Clinical Trial

Acronym: DUAL-PD-RCT

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 10, 2025
Registry last updated
May 22, 2026

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

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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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