Parkinson Disease (PD), Postural BalanceDUAL-PD-RCTNCT07013214
Rehabilitation With Dual-task Exercises to Improve Balance in Patients With Parkinson's Disease
A study testing Dual-Task Exercise and Standard Rehabilitation in people with Parkinson Disease (PD), Postural Balance, run by G. d'Annunzio University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease (PD), Postural Balance
- What is being tested?
- Dual-Task Exercise and Standard Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jul 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rehabilitation Program to Improve Balance in Patients With Parkinson's Disease: Dual-Task Exercise - A Randomized Controlled Clinical Trial
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:
Read more
- 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).
- Conditions
- Parkinson Disease (PD), Postural Balance
- Being tested
- Dual-Task Exercise, Standard Rehabilitation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-Task ExerciseBehavioural
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 RehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Dual-Task Exercise Program | Experimental | This arm consists of participants assigned to receive a structured rehabilitative pathway based on dual-task exercises. This program integrates motor and cognitive tasks simultaneously, and is designed to improve balance, reduce fall risk, and enhance autonomy and quality of life in Parkinson's patients. Participants in this group will complete a total of 20 sessions, administered 2-3 times per week for a duration of two months, with each session lasting 45 minutes. Receives: Behavioral: Dual-Task Exercise |
| Standard Rehabilitation Program | Active comparator | This arm consists of participants assigned to receive a standard rehabilitation program. This intervention focuses on traditional motor rehabilitation techniques and serves as the active control group for comparison with the dual-task intervention. Participants in this group will complete a total of 20 sessions, administered 2-3 times per week for a duration of two months, with each session lasting 45 minutes. Receives: Behavioral: Standard Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
UPDRS (Unified Parkinson's Disease Rating Scale)
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.
Measured: Baseline
Hoehn and Yahr scale
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.
Measured: Baseline
MOCA Scale (Montreal Cognitive Assessment)
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.
Measured: Baseline
Tinetti Balance and Gait scales
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.
Measured: -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion
TUG (Timed Up and Go test)
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.
Measured: -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion
Secondary outcomes (6)
Visual Analogue Scale for pain (VAS)
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.
Measured: -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion
TAMPA Scale (Tampa Scale for Kinesiophobia)
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.
Measured: -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion
Global Perceived Effect (GPE)
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.
Measured: -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion
Barthel Index
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.
Measured: -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion
EuroQoL-5D-5L (EuroQoLD5L)
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.
Measured: -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion
ABC Scale (Activities-specific Balance Confidence Scale)
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.
Measured: -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start7 Jul 2025
- Primary completion31 Dec 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD), Postural BalanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Paolucci, G. d'Annunzio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013214
- Sponsor's protocol ID
- 180426/25
- Other IDs
- 237
- Acronym
- DUAL-PD-RCT
- Status last verified
- Jul 2026
- First submitted
- 2 Jun 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Program to Improve Balance in Patients With Parkinson's Disease: Dual-Task Exercise - A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07013214
- Acronym / sponsor ID
- DUAL-PD-RCT / 180426/25
- Conditions
- Parkinson Disease (PD), Postural Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual-Task Exercise Program | Experimental | Behavioral: Dual-Task ExerciseThis arm consists of participants assigned to receive a structured rehabilitative pathway based on dual-task exercises. This program integrates motor and cognitive tasks simultaneously, and is designed to improve balance, reduce fall risk, and enhance autonomy and quality of life in Parkinson's patients. Participants in this group will complete a total of 20 sessions, administered 2-3 times per week for a duration of two months, with each session lasting 45 minutes. |
| Standard Rehabilitation Program | Active comparator | Behavioral: Standard RehabilitationThis arm consists of participants assigned to receive a standard rehabilitation program. This intervention focuses on traditional motor rehabilitation techniques and serves as the active control group for comparison with the dual-task intervention. Participants in this group will complete a total of 20 sessions, administered 2-3 times per week for a duration of two months, with each session lasting 45 minutes. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-Task ExerciseThis 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. | Behavioural | Dual-Task Exercise Program |
| Standard RehabilitationThis 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. | Behavioural | Standard Rehabilitation Program |
Primary outcome
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.
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.
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.
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.
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.
6 secondary outcomes
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-Task Exercise and Standard Rehabilitation in people with Parkinson Disease (PD), Postural Balance, run by G. d'Annunzio University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UPDRS (Unified Parkinson's Disease Rating Scale) (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.