Parkinson DiseaseNCT05799690
Comparison of Different Rehabilitation Protocols in Parkinson's Disease With Postural Instability and Gait Disorders
A study testing Gait and balance training with dual-task + action observation and motor imagery (six weeks), Gait and balance training with dual-task (six weeks) and Gait and balance training with dual-task + action observation and motor imagery (twelve weeks: 6 + 6) in people with Parkinson Disease, run by Prof. Massimo Filippi at 2 sites in Italy.
Trial summary
The aim of the study is to compare the effects of 2 different dosages and modalities of motor-cognitive rehabilitation in Parkinson's disease with postural instability and gait disorders (PD-PIGD) on clinical features, neuroimaging and blood-based biomarkers at short-term (2 months) and long-term (7 months) follow-up. Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Gait and balance training with dual-task + action observation and motor imagery (six weeks), Gait and balance training with dual-task (six weeks) and Gait and balance training with dual-task + action observation and motor imagery (twelve weeks: 6 + 6)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesItaly
- Study dates
- 30 Apr 2023to 28 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 45 years ≤ age ≤ 85 years;
- Idiopathic PD according to the Movement Disorders Society (MDS) diagnostic criteria
- Hoehn \& Yahr (H\&Y) score <= 4
- PIGD phenotype
- Stable dopaminergic medication for at least 4 weeks and without any changes during the observation period (28 weeks)
- No dementia according to Litvan's criteria and Mini-Mental Status Examination score (MMSE) >= 24
Show all 10Show fewer
- No significant tremor/involuntary movements that could determine artifacts during the MRI acquisition
- Oral and written informed consent to study participation
- sex-matched and age-matched (age range: mean age of PD years ± 15 years);
- oral and written informed consent to study participation
Who cannot join
- Medical conditions or substance abuse that could interfere with cognition;
- Any major systemic, psychiatric, neurological, visual, and musculoskeletal disturbances or other causes of walking inability;
- Contraindications to undergoing MRI examination;
- Brain damage at routine MRI, including lacunae and extensive cerebrovascular disorders;
- Denied oral and written informed consent to study participation.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
IRCCS San Raffaele
Milan, 20132
Neurology Unit, Azienda Ospedaliera Universitaria Integrata di Verona
Verona, 37126
About this study
Official title: Multiparametric Biomarkers to Predict the Response to Different Protocols of Motor-cognitive Rehabilitation in Parkinson's Disease Subjects With Postural Instability and Gait Disorders
The aim of the study is to compare the effects of 2 different dosages and modalities of motor-cognitive rehabilitation in Parkinson's disease with postural instability and gait disorders (PD-PIGD) on clinical features, neuroimaging and blood-based biomarkers at short-term (2 months) and long-term (7 months) follow-up. Fifty subjects with PD-PIGD will be randomized in 2 training groups: DUAL-TASK+AOT-MI and the DUAL-TASK groups. The DUAL-TASK+AOT-MI group will perform a dual-task gait/balance training consisting of action observation training (AOT) and motor imagery (MI) combined with practicing the observed-imagined exercises; DUAL-TASK group will perform the same exercises combined with watching landscape videos. The training will last 6 weeks, 3 times/week, 1 hour per session.
Before and after training (W6), all the patients will undergo neurological, gait/balance, cognitive/behavioral, magnetic resonance imaging (MRI) and serum biomarkers evaluations. Neurological, gait/balance, cognitive/behavioral assessments and serum biomarkers will be also repeated at the 14-week follow-up (W14) to assess maintenance of results.
Patients of both DUAL-TASK+AOT-MI and DUAL-TASK groups will be further randomized to repeat the training (6 weeks, 3 times/week, 1 hour each session) starting at W14 (DUAL-TASK+AOT-MI_DOUBLE and DUAL-TASK_DOUBLE groups). After six weeks (W20) all the subjects repeating the training will be evaluated (neurological, gait/balance, cognitive/behavioral assessments). At 28-week follow-up (W28), the whole sample of patients will be assessed with neurological, gait/balance, cognitive/behavioral, MRI and serum biomarkers evaluations. All MRI scans will be acquired at least 12 hours after last dopaminergic therapy administration to mitigate the pharmacological effects on neural activity. Twenty age- and sex-matched healthy controls will be recruited to perform gait/balance and cognitive/behavioral assessments, blood sample and brain MRI acquisition at baseline. The secondary aims of the study are to define the neuroimaging and blood-based biomarkers of PD-PIGD patients presenting different clinical features (e.g. presence of mild cognitive impairment, freezing of gait, falls and mood disturbances) and to evaluate the role of blood-based and neuroimaging biomarkers, together with clinical characteristics, in predicting the response to different dosages of rehabilitation in PD-PIGD throughout the development of a machine-learning algorithm.
- Conditions
- Parkinson Disease
- Being tested
- Gait and balance training with dual-task + action observation and motor imagery (six weeks), Gait and balance training with dual-task (six weeks), Gait and balance training with dual-task + action observation and motor imagery (twelve weeks: 6 + 6), Gait and balance training with dual-task (twelve weeks: 6 +6)
- Keywords
- Parkinson Disease, Gait, Rehabilitation, Biomarkers, Magnetic resonance imaging
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait and balance training with dual-task + action observation and motor imagery (six weeks)Behavioural
Increasingly difficult gait and balance exercises up to include dual-task. During each training session, four exercises (5 minutes of execution, two times each) will be proposed. Patients will observe a 2-minute video clip showing a balance or gait task (action observation - AOT) and will imagine the same exercise (motor-imagery - MI) before task execution. Each training session will be proposed with the following modality: 2 minutes of AOT - 5 minutes of task execution - 2 minutes of MI - 5 minutes of task execution. Patients will be explicitly asked to concentrate on how the actions are performed in the videos and to carefully use MI to improve their motor performance. Patients will not be allowed to perform any movement while watching videos or during MI.
1 hour, 3 times a week for six weeks.
Gait and balance training with dual-task (six weeks)Behavioural
Increasingly difficult gait and balance exercises up to include dual-task. During each training session, four exercises (5 minutes of execution, two times each) will be proposed. Patients will observe a 2-minute video clip showing static landscapes before task execution. Each training session will be proposed with the following modality: 2 minutes of videos - 5 minutes of task execution - 2 minutes of videos - 5 minutes of task execution.
1 hour, 3 times a week for six weeks.
Gait and balance training with dual-task + action observation and motor imagery (twelve weeks: 6 + 6)Behavioural
Increasingly difficult gait and balance exercises up to include dual-task. During each training session, four exercises (5 minutes of execution, two times each) will be proposed. Patients will observe a 2-minute video clip showing a balance or gait task (action observation - AOT) and will imagine the same exercise (motor-imagery - MI) before task execution. Each training session will be proposed with the following modality: 2 minutes of AOT - 5 minutes of task execution - 2 minutes of MI - 5 minutes of task execution. Patients will be explicitly asked to concentrate on how the actions are performed in the videos and to carefully use MI to improve their motor performance. Patients will not be allowed to perform any movement while watching videos or during MI.
The training protocol will be repeated two times: once starting at baseline, once starting after the first follow-up at week 14 (W14)
1 hour, 3 times a week for twelve weeks (6+6).
Gait and balance training with dual-task (twelve weeks: 6 +6)Behavioural
Increasingly difficult gait and balance exercises up to include dual-task. During each training session, four exercises (5 minutes of execution, two times each) will be proposed. Patients will observe a 2-minute video clip showing static landscapes before task execution. Each training session will be proposed with the following modality: 2 minutes of videos - 5 minutes of task execution - 2 minutes of videos - 5 minutes of task execution.
The training protocol will be repeated two times: once starting at baseline, once starting after the first follow-up at week 14 (W14)
1 hour, 3 times a week for twelve weeks (6+6).
| Study group | Role | What they receive |
|---|---|---|
| DUAL-TASK+AOT-MI | Experimental | Dual-task gait and balance training with cognitive facilitations (action observation and motor imagery) for six weeks. Receives: Behavioral: Gait and balance training with dual-task + action observation and motor imagery (six weeks) |
| DUAL-TASK | Active comparator | Dual-task gait and balance training with vision of landscape videos for six weeks. Receives: Behavioral: Gait and balance training with dual-task (six weeks) |
| DUAL-TASK+AOT-MI_DOUBLE | Experimental | Dual-task gait and balance training with cognitive facilitations (action observation and motor imagery) repeated two times (twelve weeks: 6 + 6). Receives: Behavioral: Gait and balance training with dual-task + action observation and motor imagery (twelve weeks: 6 + 6) |
| DUAL-TASK_DOUBLE | Active comparator | Dual-task gait and balance training with vision of landscape videos repeated two times (twelve weeks: 6 + 6). Receives: Behavioral: Gait and balance training with dual-task (twelve weeks: 6 +6) |
| Healthy subjects | No intervention | Age- and sex-matched healthy subjects recruited to compare gait, neuropsychological, serum and functional magnetic resonance imaging characteristics at baseline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total execution time of Timed Up and Go test with cognitive dual-task (TUG-COG)
Changes in time taken to complete the timed up and go test with cognitive dual-task: patients are asked to stand up from a chair, walk for three meters, turn and walk back to the chair while counting backwards by 3 starting from 100. Assessment during ON medication phase.
Measured: Baseline, week 6, week 14 and week 28. At week 20 only for patients repeating the training.
Secondary outcomes (22)
Total execution time of Timed Up and Go test (TUG)
Changes in time taken to complete the timed up and go test: patients are asked to stand up from a chair, walk for three meters, turn, and walk back to the chair. Assessment during ON medication phase
Measured: Baseline, week 6, week 14 and week 28. At week 20 only for patients repeating the training.
Total execution time of Timed Up and Go test with manual dual-task (TUG-MAN)
Changes in time taken to complete the timed up and go test with manual dual-task: patients are asked to stand up from a chair, walk for three meters, turn, and walk back to the chair while holding a glass full of water. Assessment during ON medication phase
Measured: Baseline, week 6, week 14 and week 28. At week 20 only for patients repeating the training.
Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score
MDS-UPDRS evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. The MDS-UPDRS contains 65 items divided in four parts (Part I - "non-motor experiences of daily living", Part II - "motor experiences of daily living", Part III - "motor examination", Part IV - "motor complications. Each item is assessed with a 0 to 4 rating system. The total score ranges from 0 to 260 with higher score indicating more severe symptoms.
Assessment during ON medication. Only part III assessed also without medication (OFF).
Measured: Baseline, week 6, week 14 and week 28. At week 20 only for patients repeating the training.
Brain functional changes during functional magnetic resonance imaging (MRI) tasks
Changes in functional MRI brain activity assessed during a motor task, a cognitive task and a dual-task. Assessment during OFF medication phase, at least 12 hours after last medication assumption.
Measured: Baseline, week 6 and week 28
Serum concentration of Neurofilament light chain (NfL)
Serum biomarker of neuroprotection/neurodegeneration
Measured: Baseline, week 6, week 14 and week 28.
Serum concentration of Glial Fibrillary Acid Protein (GFAP)
Serum biomarker of neuroprotection/neurodegeneration
Measured: Baseline, week 6, week 14 and week 28.
Serum concentration of Phosphorylated Tau (P-Tau)
Serum biomarker of neuroprotection/neurodegeneration
Measured: Baseline, week 6, week 14 and week 28.
Serum concentration of Tau
Serum biomarker of neuroprotection/neurodegeneration
Measured: Baseline, week 6, week 14 and week 28.
Serum concentration of B42
Serum biomarker of neuroprotection/neurodegeneration
Measured: Baseline, week 6, week 14 and week 28.
Serum concentration of B40
Serum biomarker of neuroprotection/neurodegeneration
Measured: Baseline, week 6, week 14 and week 28.
Serum concentration of Alpha-synuclein
Serum biomarker of neuroprotection/neurodegeneration
Measured: Baseline, week 6, week 14 and week 28.
Serum concentration of Brain Derived Neurotrophic Factor (BDNF)
Serum biomarker of neuroprotection/neurodegeneration
Measured: Baseline, week 6, week 14 and week 28.
Activity Balance Confidence questionnaire (ABC) score
This questionnaire assesses patient-referred balance confidence during 16 daily tasks. Subjects rate their confidence while doing each activity from 0 (no confidence) to 100 (full confidence).
Assessment during ON medication phase.
Measured: Baseline, week 6, week 14 and week 28. At week 20 only for patients repeating the training.
10-meter walk test (10MWT) time
Time taken to walk 10 straight meters. Test performed at comfortable and maximal speed. Assessment during ON medication phase.
Measured: Baseline, week 6, week 14 and week 28. At week 20 only for patients repeating the training.
Mini Balance Evaluation System Test (MiniBESTest) score
Assessment of different balance systems (anticipatory, reactive postural control, sensory orientation, dynamic gait). MiniBESTest includes 14 items with a score from 0 (severe/unable) to 2 (normal). The maximum score is 28 and a higher score indicates a better balance.
Assessment during ON medication phase.
Measured: Baseline, week 6, week 14 and week 28. At week 20 only for patients repeating the training.
Five-time sit-to-stand (5STS) time
This test measures the amount of time it takes for a patient to stand up and sit down five times in a row, as quickly as possible with arms folded across their chest. Assessment during ON medication phase.
Measured: Baseline, week 6, week 14 and week 28. At week 20 only for patients repeating the training.
Parkinson's Disease Questionnaire (PDQ-39) score
Parkinson's Disease Questionnaire investigates the quality of life of PD patients. It includes 39 questions with 5 possible answers (never, occasionally, sometimes, often, always) and 8 sub-items related to mobility, activities of daily living, emotional well-being, signs of discouragement, social support, cognitions, communication and bodily discomfort. The maximum score is 100 and a low score is an indicator of a good quality of life. Assessment during ON medication phase.
Measured: Baseline, week 6, week 14 and week 28. At week 20 only for patients repeating the training.
Stride length
Gait parameter obtained using wearable motion sensors. Assessment during ON medication phase.
Measured: Baseline, week 6, week 14 and week 28. At week 20 only for patients repeating the training.
Gait velocity
Gait parameter obtained using wearable motion sensors. Assessment during ON medication phase.
Measured: Baseline, week 6, week 14 and week 28. At week 20 only for patients repeating the training.
Cambridge Neuropsychological Test Automated Battery (CANTAB)
This battery of cognitive tests assesses executive functions, memory and visuospatial abilities.
Each subtest of the CANTAB battery provides outcome measures in terms of accuracy (right answers, errors and/or missing answers) and reaction times (highest scores are worse) for every condition within the subtest (the different conditions present with different levels of cognitive load). Assessment during ON medication phase.
Measured: Baseline, week 6, week 14 and week 28. At week 20 only for patients
Kinesthetic and Visual Imagery Questionnaire (KVIQ)
This questionnaire assesses motor imagery abilities. The Kinesthetic and Visual Imagery Questionnaire (KVIQ) includes 10 items assessing the clarity of the image and the intensity of the sensations that the subject is able to imagine from the first-person perspective (both right and left sides) on a five-point ordinal scale. Total score ranges from 0 to 50 with higher score indicating better motor imagery abilities. Assessment during ON medication phase.
Measured: Baseline, week 6 and week 28.
New Freezing of Gait Questionnaire (NFoG-Q)
This is a self-reported questionnaire that measures freezing of gait. It consists of 9 items with a total score ranging from 0 (no freezing) to 28. Higher score indicates worse freezing. Assessment during ON medication phase.
Measured: Baseline, week 6, week 14 and week 28. At week 20 only for patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start30 Apr 2023
- Primary completion30 Jul 2026 (estimated)
- Study completion28 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind randomized controlled trial. Fifty PD patients are randomly divided into two groups: 25 in DUAL-TASK+AOT-MI (experimental) and 25 in the DUAL-TASK (active comparator). Half of the patients are further randomized to repeat the treatment (DUAL-TASK+AOT-MI\_DOUBLE and DUAL-TASK\_DOUBLE). The assessors are blinded to the group allocation. In addition, a group of 20 healthy age- and sex-matched control is included at baseline
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Massimo Filippi
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Integrata Verona
- Responsible party
- Sponsor-investigator, Prof. Massimo Filippi, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799690
- Sponsor's protocol ID
- GR-2021-12374005
- Status last verified
- May 2025
- First submitted
- 17 Mar 2023
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric Biomarkers to Predict the Response to Different Protocols of Motor-cognitive Rehabilitation in Parkinson's Disease Subjects With Postural Instability and Gait Disorders
- ClinicalTrials.gov ID
- NCT05799690
- Acronym / sponsor ID
- GR-2021-12374005
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Gait, Rehabilitation, Biomarkers, Magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Prof. Massimo FilippiUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Integrata Verona
- Study start
- 30 Apr 2023 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 28 Apr 2027 (estimated)
- First posted
- 5 Apr 2023 (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 aim of the study is to compare the effects of 2 different dosages and modalities of motor-cognitive rehabilitation in Parkinson's disease with postural instability and gait disorders (PD-PIGD) on clinical features, neuroimaging and blood-based biomarkers at short-term (2 months) and long-term (7 months) follow-up. Fifty subjects with PD-PIGD will be randomized in 2 training groups: DUAL-TASK+AOT-MI and the DUAL-TASK groups. The DUAL-TASK+AOT-MI group will perform a dual-task gait/balance training consisting of action observation training (AOT) and motor imagery (MI) combined with practicing the observed-imagined exercises; DUAL-TASK group will perform the same exercises combined with watching landscape videos. The training will last 6 weeks, 3 times/week, 1 hour per session.
Before and after training (W6), all the patients will undergo neurological, gait/balance, cognitive/behavioral, magnetic resonance imaging (MRI) and serum biomarkers evaluations. Neurological, gait/balance, cognitive/behavioral assessments and serum biomarkers will be also repeated at the 14-week follow-up (W14) to assess maintenance of results.
Patients of both DUAL-TASK+AOT-MI and DUAL-TASK groups will be further randomized to repeat the training (6 weeks, 3 times/week, 1 hour each session) starting at W14 (DUAL-TASK+AOT-MI_DOUBLE and DUAL-TASK_DOUBLE groups). After six weeks (W20) all the subjects repeating the training will be evaluated (neurological, gait/balance, cognitive/behavioral assessments). At 28-week follow-up (W28), the whole sample of patients will be assessed with neurological, gait/balance, cognitive/behavioral, MRI and serum biomarkers evaluations. All MRI scans will be acquired at least 12 hours after last dopaminergic therapy administration to mitigate the pharmacological effects on neural activity. Twenty age- and sex-matched healthy controls will be recruited to perform gait/balance and cognitive/behavioral assessments, blood sample and brain MRI acquisition at baseline. The secondary aims of the study are to define the neuroimaging and blood-based biomarkers of PD-PIGD patients presenting different clinical features (e.g. presence of mild cognitive impairment, freezing of gait, falls and mood disturbances) and to evaluate the role of blood-based and neuroimaging biomarkers, together with clinical characteristics, in predicting the response to different dosages of rehabilitation in PD-PIGD throughout the development of a machine-learning algorithm.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- Model description
- Single-blind randomized controlled trial. Fifty PD patients are randomly divided into two groups: 25 in DUAL-TASK+AOT-MI (experimental) and 25 in the DUAL-TASK (active comparator). Half of the patients are further randomized to repeat the treatment (DUAL-TASK+AOT-MI_DOUBLE and DUAL-TASK_DOUBLE). The assessors are blinded to the group allocation. In addition, a group of 20 healthy age- and sex-matched control is included at baseline
| Arm | Type | Receives |
|---|---|---|
| DUAL-TASK+AOT-MI | Experimental | Behavioral: Gait and balance training with dual-task + action observation and motor imagery (six weeks)Dual-task gait and balance training with cognitive facilitations (action observation and motor imagery) for six weeks. |
| DUAL-TASK | Active comparator | Behavioral: Gait and balance training with dual-task (six weeks)Dual-task gait and balance training with vision of landscape videos for six weeks. |
| DUAL-TASK+AOT-MI_DOUBLE | Experimental | Behavioral: Gait and balance training with dual-task + action observation and motor imagery (twelve weeks: 6 + 6)Dual-task gait and balance training with cognitive facilitations (action observation and motor imagery) repeated two times (twelve weeks: 6 + 6). |
| DUAL-TASK_DOUBLE | Active comparator | Behavioral: Gait and balance training with dual-task (twelve weeks: 6 +6)Dual-task gait and balance training with vision of landscape videos repeated two times (twelve weeks: 6 + 6). |
| Healthy subjects | No intervention | –Age- and sex-matched healthy subjects recruited to compare gait, neuropsychological, serum and functional magnetic resonance imaging characteristics at baseline. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 45 years ≤ age ≤ 85 years;
- Idiopathic PD according to the Movement Disorders Society (MDS) diagnostic criteria
- Hoehn \& Yahr (H\&Y) score <= 4
- PIGD phenotype
- Stable dopaminergic medication for at least 4 weeks and without any changes during the observation period (28 weeks)
Key exclusion criteria (5 listed)
- Medical conditions or substance abuse that could interfere with cognition;
- Any major systemic, psychiatric, neurological, visual, and musculoskeletal disturbances or other causes of walking inability;
- Contraindications to undergoing MRI examination;
- Brain damage at routine MRI, including lacunae and extensive cerebrovascular disorders;
- Denied oral and written informed consent to study participation.
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 |
|---|---|---|
| Gait and balance training with dual-task + action observation and motor imagery (six weeks)Increasingly difficult gait and balance exercises up to include dual-task. During each training session, four exercises (5 minutes of execution, two times each) will be proposed. Patients will observe a 2-minute video clip showing a balance or gait task (action observation - AOT) and will imagine the same exercise (motor-imagery - MI) before task execution. Each training session will be proposed with the following modality: 2 minutes of AOT - 5 minutes of task execution - 2 minutes of MI - 5 minutes of task execution. Patients will be explicitly asked to concentrate on how the actions are performed in the videos and to carefully use MI to improve their motor performance. Patients will not be allowed to perform any movement while watching videos or during MI. 1 hour, 3 times a week for six weeks. | Behavioural | DUAL-TASK+AOT-MI |
| Gait and balance training with dual-task (six weeks)Increasingly difficult gait and balance exercises up to include dual-task. During each training session, four exercises (5 minutes of execution, two times each) will be proposed. Patients will observe a 2-minute video clip showing static landscapes before task execution. Each training session will be proposed with the following modality: 2 minutes of videos - 5 minutes of task execution - 2 minutes of videos - 5 minutes of task execution. 1 hour, 3 times a week for six weeks. | Behavioural | DUAL-TASK |
| Gait and balance training with dual-task + action observation and motor imagery (twelve weeks: 6 + 6)Increasingly difficult gait and balance exercises up to include dual-task. During each training session, four exercises (5 minutes of execution, two times each) will be proposed. Patients will observe a 2-minute video clip showing a balance or gait task (action observation - AOT) and will imagine the same exercise (motor-imagery - MI) before task execution. Each training session will be proposed with the following modality: 2 minutes of AOT - 5 minutes of task execution - 2 minutes of MI - 5 minutes of task execution. Patients will be explicitly asked to concentrate on how the actions are performed in the videos and to carefully use MI to improve their motor performance. Patients will not be allowed to perform any movement while watching videos or during MI. The training protocol will be repeated two times: once starting at baseline, once starting after the first follow-up at week 14 (W14) 1 hour, 3 times a week for twelve weeks (6+6). | Behavioural | DUAL-TASK+AOT-MI_DOUBLE |
| Gait and balance training with dual-task (twelve weeks: 6 +6)Increasingly difficult gait and balance exercises up to include dual-task. During each training session, four exercises (5 minutes of execution, two times each) will be proposed. Patients will observe a 2-minute video clip showing static landscapes before task execution. Each training session will be proposed with the following modality: 2 minutes of videos - 5 minutes of task execution - 2 minutes of videos - 5 minutes of task execution. The training protocol will be repeated two times: once starting at baseline, once starting after the first follow-up at week 14 (W14) 1 hour, 3 times a week for twelve weeks (6+6). | Behavioural | DUAL-TASK_DOUBLE |
Primary outcome
Total execution time of Timed Up and Go test with cognitive dual-task (TUG-COG)
Time frame: Baseline, week 6, week 14 and week 28. At week 20 only for patients repeating the training.
Changes in time taken to complete the timed up and go test with cognitive dual-task: patients are asked to stand up from a chair, walk for three meters, turn and walk back to the chair while counting backwards by 3 starting from 100. Assessment during ON medication phase.
22 secondary outcomes
Total execution time of Timed Up and Go test (TUG)
Time frame: Baseline, week 6, week 14 and week 28. At week 20 only for patients repeating the training.
Total execution time of Timed Up and Go test with manual dual-task (TUG-MAN)
Time frame: Baseline, week 6, week 14 and week 28. At week 20 only for patients repeating the training.
Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score
Time frame: Baseline, week 6, week 14 and week 28. At week 20 only for patients repeating the training.
Brain functional changes during functional magnetic resonance imaging (MRI) tasks
Time frame: Baseline, week 6 and week 28
Serum concentration of Neurofilament light chain (NfL)
Time frame: Baseline, week 6, week 14 and week 28.
Serum concentration of Glial Fibrillary Acid Protein (GFAP)
Time frame: Baseline, week 6, week 14 and week 28.
Serum concentration of Phosphorylated Tau (P-Tau)
Time frame: Baseline, week 6, week 14 and week 28.
Serum concentration of Tau
Time frame: Baseline, week 6, week 14 and week 28.
Serum concentration of B42
Time frame: Baseline, week 6, week 14 and week 28.
Serum concentration of B40
Time frame: Baseline, week 6, week 14 and week 28.
Serum concentration of Alpha-synuclein
Time frame: Baseline, week 6, week 14 and week 28.
Serum concentration of Brain Derived Neurotrophic Factor (BDNF)
Time frame: Baseline, week 6, week 14 and week 28.
Activity Balance Confidence questionnaire (ABC) score
Time frame: Baseline, week 6, week 14 and week 28. At week 20 only for patients repeating the training.
10-meter walk test (10MWT) time
Time frame: Baseline, week 6, week 14 and week 28. At week 20 only for patients repeating the training.
Mini Balance Evaluation System Test (MiniBESTest) score
Time frame: Baseline, week 6, week 14 and week 28. At week 20 only for patients repeating the training.
Five-time sit-to-stand (5STS) time
Time frame: Baseline, week 6, week 14 and week 28. At week 20 only for patients repeating the training.
Parkinson's Disease Questionnaire (PDQ-39) score
Time frame: Baseline, week 6, week 14 and week 28. At week 20 only for patients repeating the training.
Stride length
Time frame: Baseline, week 6, week 14 and week 28. At week 20 only for patients repeating the training.
Gait velocity
Time frame: Baseline, week 6, week 14 and week 28. At week 20 only for patients repeating the training.
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: Baseline, week 6, week 14 and week 28. At week 20 only for patients
Kinesthetic and Visual Imagery Questionnaire (KVIQ)
Time frame: Baseline, week 6 and week 28.
New Freezing of Gait Questionnaire (NFoG-Q)
Time frame: Baseline, week 6, week 14 and week 28. At week 20 only for patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait and balance training with dual-task + action observation and motor imagery (six weeks), Gait and balance training with dual-task (six weeks) and Gait and balance training with dual-task + action observation and motor imagery (twelve weeks: 6 + 6) in people with Parkinson Disease, run by Prof. Massimo Filippi at 2 sites 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 10 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Total execution time of Timed Up and Go test with cognitive dual-task (TUG-COG) (time frame: Baseline, week 6, week 14 and week 28. At week 20 only for patients repeating the training.). 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 9 Mar 2026.