PARKINSON DISEASE (Disorder)P_FeasibilityNCT07833748
Integrated Motor-Cognitive Training in Parkinson's Disease: A Feasibility Study
A study testing Combined group motor training and individual digital cognitive stimulation in people with PARKINSON DISEASE (Disorder), run by University Hospital of Ferrara at 1 site in Italy.
Trial summary
Parkinson's disease is a progressive neurodegenerative condition characterized by both motor symptoms (such as bradykinesia, rigidity, tremor, and postural instability) and non-motor symptoms, including cognitive impairments (affecting working memory, executive functions, and attention). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- What is being tested?
- Combined group motor training and individual digital cognitive stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2026to Sep 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Parkinson's disease
- Presence of motor symptoms attributable to Parkinson's disease
- Availability to participate in both treatments (cognitive and motor)
- Severity of symptoms compatible with participation in group physical therapy
- Absence of other medical conditions that could interfere with treatment delivery
- Montreal Cognitive Assessment (MoCA) score >= 18
- Consent to participate in group-based motor training
- Absence of falls in the 3 months prior to baseline evaluation
Who cannot join
- Concomitant major neurological or psychiatric disorders
- Severe cardio-pulmonary, renal, or hepatic diseases
- Changes in baseline pharmacological therapy within 3 months prior to enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Ferrara University Hospital
Ferrara, FE, 44124
Sofia Straudi, MD, PhD, 0532238720, sofia.straudi@unife.it
Gaia Palma, PhD student, Psychologist
About this study
Parkinson's disease is a progressive neurodegenerative condition characterized by both motor symptoms (such as bradykinesia, rigidity, tremor, and postural instability) and non-motor symptoms, including cognitive impairments (affecting working memory, executive functions, and attention). Combined interventions that target both domains simultaneously or consecutively have shown potential to produce superior benefits compared to isolated motor or cognitive training.
The purpose of this study is to evaluate the feasibility, adherence, and preliminary clinical results of efficacy of an integrated and combined motor-cognitive rehabilitation training in patients diagnosed with Parkinson's disease.
This feasibility study will enroll 12 participants with Parkinson's disease. All participants will undergo a comprehensive 10-session integrated rehabilitation program combining digital cognitive individual stimulation and group functional motor training. The primary focus is to assess acceptability, safety, and adherence to this combined approach, while secondary outcomes will observe changes in relevant cognitive and motor clinical variables.
- Conditions
- PARKINSON DISEASE (Disorder)
- Being tested
- Combined group motor training and individual digital cognitive stimulation
- Keywords
- Parkinson Disease, Motor-Cognitive Training, Cognitive Rehabilitation, Motor 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.
Combined group motor training and individual digital cognitive stimulationBehavioural
Participants complete a 10-session motor-cognitive training program (3 times per week). Interventions occur on the same day in groups of 3, supervised by a neuropsychologist and physiotherapist.
- Cognitive Session (30 min): Training delivered individually and tailored to baseline, individual-specific deficits using the NeuronUP application. Each session includes 5 gamified exercise types (4 minutes each) with adaptive difficulty and optional 2-minute breaks.
- Motor Session (1 h): Group circuit of 6 stations (7 minutes for station, 2-min breaks): Stations 1-2: Cardiovascular (stepping, sit-to-stand); 3: Dynamic balance with external constraints (stepping over obstacles); 4: Dynamic balance with internal constraints (walking around obstacles); 5: Static balance exercises; 6: Functional movement transfers (Floor-to-standing)
| Study group | Role | What they receive |
|---|---|---|
| Combined Motor-Cognitive Training Group | Experimental | Participants will receive a 10-session integrated rehabilitation program combining individual digital cognitive stimulation and group functional motor training Receives: Behavioral: Combined group motor training and individual digital cognitive stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Outcomes: Eligibility Rate
Calculated as the ratio of eligible patients to the total number of screened patients.
Measured: Baseline
Feasibility Outcomes: Recruitment Rate
Calculated as the ratio of recruited patients to total eligible patients.
Measured: Baseline
Feasibility Outcomes: Monthly Recruitment Rate
Defined as the average number of participants enrolled per month.
Measured: Baseline
Feasibility Outcomes: Drop-out Rate
The percentage of participants who withdraw from the study.
Measured: score changes after intervention (4 weeks, T1)
Feasibility Outcomes: Adherence Rate
The percentage of scheduled training sessions attended
Measured: score changes after intervention (4 weeks, T1)
Feasibility Outcomes: Longitudinal Retention Rate
The percentage of enrolled participants who complete all follow-up assessments
Measured: Post-intervention follow-up assessment (3 months after intervention completion)
Feasibility Outcomes: Self-Reported Acceptability
Participants will complete a questionnaire at the end of the intervention to evaluate their subjective experience, perceived benefits, and difficulties of the treatment. Items are rated on a 5-point Likert scale ranging from 1 ("low") to 5 ("extremely high"), with higher scores indicating a more positive evaluation or greater perceived benefit/difficulty.
Measured: score changes after intervention (4 weeks, T1)
Feasibility Outcomes: Adverse Events
The incidence and severity of any adverse events (e.g., falls or excessive fatigue) recorded during the study.
Measured: score changes after intervention (4 weeks, T1)
Feasibility Outcomes: Motor Exercise Intensity
The Borg Rating of Perceived Exertion (RPE) will be used to monitor and quantify physical and cognitive effort. Total score ranges from 6 to 20. Higher scores indicate greater perceived exertion
Measured: Monitored during every training session (Up to 4 weeks, from Sessions 1 through 10)
Feasibility Outcomes: Motor Exercise Exertion
The Borg Intensity Scale-Exerciser (BIS-E) will be used to quantify exertion. Total score ranges from 0 to 30, higher scores indicate greater perceived balance effort, difficulty, and postural instability during circuit stations.
Measured: Monitored during every training session (Up to 4 weeks, from Sessions 1 through 10)
Feasibility Outcomes: Digital Cognitive Progression Index (NeuronUP Activity Score)
Digital Cognitive Progression Index (NeuronUP Activity Score) will be used to quantifies session-by-session cognitive performance and adaptive difficulty progression across the 10 training sessions. The score is calculated using NeuronUP's standardized algorithm based on accuracy, total completed phases, and maximum difficulty reached, yielding a score from 0 to 100. Higher scores reflect greater task proficiency and successful progression to higher difficulty levels. This metric serves as an exploratory/feasibility measure of intra-intervention cognitive learning.
Measured: Monitored during every training session (Up to 4 weeks, from Sessions 1 through 10)
Secondary outcomes (13)
Motor Outcomes: Change in dynamic balance, mobility, and gait
The Timed Up and Go Test (TUG Single Task) will be used to assess the change in dynamic balance, mobility, and gait. Evaluated as time (in seconds). Lower time indicates better functional mobility.
Measured: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
Motor Outcomes: Change in Gait speed
10-Meter Walk Test (10MWT) will be used to assess change in gait speed over a 10-meter distance. Evaluated as speed in meters per second (m/s). Higher values indicate faster walking speed and improved gait dynamics.
Measured: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
Motor Outcomes: Change in Distance Walked
The 6-Minute Walk Test (6MWT) will be used to assess change in total distance walked (in meters) within 6 minutes. Evaluated as total distance walked (in meters) within 6 minutes. Higher distance indicates superior physical endurance.
Measured: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
Motor Outcomes: Change in Dynamic Balance
Mini-BESTest Total Score will be used to assess change dynamic balance abilities across four subscales (anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait).Total score ranges from 0 to 28, with higher scores indicating superior dynamic balance and lower fall risk.
Measured: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
Motor Outcomes: Change in Finger motor speed
The Finger Tapping Test Performance will be used to assess motor speed. Measures include total number of taps (right and left hand). Higher tap counts indicate better motor control.
Measured: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
Cognitive Outcomes: Change in Global cognitive function
The Montreal Cognitive Assessment (MoCA) total score will be used to assess global cognitive function. The scale ranges from 0 to 30, with higher scores indicating better global cognitive function (a score of 26 or above is generally considered normal).
Measured: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
Cognitive Outcomes: Change in Visual search and processing speed
The Trail Making Test Part A (TMT-A) will be used to assess visual search abilities and processing speed.
Measured: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
Cognitive Outcomes: Change in executive function, cognitive flexibility, and set-shifting.
The Trail Making Test Part B (TMT-B) Time will be used to assess executive function, cognitive flexibility, and set-shifting.
Measured: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
Cognitive Outcomes: Change in Information processing speed and attention
The Symbol Digit Modalities Test (SDMT) will be used to assess information processing speed and attention.
Measured: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
Cognitive Outcomes: Decision-making processing speed and cognitive-motor control
The Choice Reaction Time (CRT) Task will be used to assess decision-making processing speed and cognitive-motor control. Evaluated via number of correct responses, mean reaction time (in milliseconds) for correct responses, and mean reaction time for error responses. Lower reaction times and higher correct rates indicate better performance.
Measured: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
Cognitive Outcomes: Change in perceptive-motor speed
The Simple Reaction Time (SRT) will be used to assess reaction time speed. Evaluated as mean reaction time (in milliseconds) for correct responses and number of correct responses. Lower reaction times indicate faster processing speed; Higher correct responses indicate better accuracy.
Measured: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
Change in Quality of Life
The EQ-5D Quality of Life Questionnaire will be used to assess health-related quality of life across 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Higher scores indicate superior quality of life.
Measured: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
Change in Fatigue
The Parkinson Fatigue Scale (PFS-16) will be used to assess the impact of fatigue specific to Parkinson's disease. Total mean score ranges from 1 to 5. Higher scores indicate greater perceived fatigue.
Measured: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Jun 2026
- Primary completion31 Aug 2026
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833748
- Sponsor's protocol ID
- 710/2025/Oss/AOUFe
- Acronym
- P_Feasibility
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Motor-Cognitive Training in Parkinson's Disease: A Feasibility Study
- ClinicalTrials.gov ID
- NCT07833748
- Acronym / sponsor ID
- P_Feasibility / 710/2025/Oss/AOUFe
- Conditions
- PARKINSON DISEASE (Disorder)
- Keywords
- Parkinson Disease, Motor-Cognitive Training, Cognitive Rehabilitation, Motor Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 22 Sep 2026 (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.
Parkinson's disease is a progressive neurodegenerative condition characterized by both motor symptoms (such as bradykinesia, rigidity, tremor, and postural instability) and non-motor symptoms, including cognitive impairments (affecting working memory, executive functions, and attention). Combined interventions that target both domains simultaneously or consecutively have shown potential to produce superior benefits compared to isolated motor or cognitive training.
The purpose of this study is to evaluate the feasibility, adherence, and preliminary clinical results of efficacy of an integrated and combined motor-cognitive rehabilitation training in patients diagnosed with Parkinson's disease.
This feasibility study will enroll 12 participants with Parkinson's disease. All participants will undergo a comprehensive 10-session integrated rehabilitation program combining digital cognitive individual stimulation and group functional motor training. The primary focus is to assess acceptability, safety, and adherence to this combined approach, while secondary outcomes will observe changes in relevant cognitive and motor clinical variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined Motor-Cognitive Training Group | Experimental | Behavioral: Combined group motor training and individual digital cognitive stimulationParticipants will receive a 10-session integrated rehabilitation program combining individual digital cognitive stimulation and group functional motor training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of Parkinson's disease
- Presence of motor symptoms attributable to Parkinson's disease
- Availability to participate in both treatments (cognitive and motor)
- Severity of symptoms compatible with participation in group physical therapy
- Absence of other medical conditions that could interfere with treatment delivery
Key exclusion criteria (3 listed)
- Concomitant major neurological or psychiatric disorders
- Severe cardio-pulmonary, renal, or hepatic diseases
- Changes in baseline pharmacological therapy within 3 months prior to enrollment
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 |
|---|---|---|
| Combined group motor training and individual digital cognitive stimulationParticipants complete a 10-session motor-cognitive training program (3 times per week). Interventions occur on the same day in groups of 3, supervised by a neuropsychologist and physiotherapist. * Cognitive Session (30 min): Training delivered individually and tailored to baseline, individual-specific deficits using the NeuronUP application. Each session includes 5 gamified exercise types (4 minutes each) with adaptive difficulty and optional 2-minute breaks. * Motor Session (1 h): Group circuit of 6 stations (7 minutes for station, 2-min breaks): Stations 1-2: Cardiovascular (stepping, sit-to-stand); 3: Dynamic balance with external constraints (stepping over obstacles); 4: Dynamic balance with internal constraints (walking around obstacles); 5: Static balance exercises; 6: Functional movement transfers (Floor-to-standing) | Behavioural | Combined Motor-Cognitive Training Group |
Primary outcome
Feasibility Outcomes: Eligibility Rate
Time frame: Baseline
Calculated as the ratio of eligible patients to the total number of screened patients.
Feasibility Outcomes: Recruitment Rate
Time frame: Baseline
Calculated as the ratio of recruited patients to total eligible patients.
Feasibility Outcomes: Monthly Recruitment Rate
Time frame: Baseline
Defined as the average number of participants enrolled per month.
Feasibility Outcomes: Drop-out Rate
Time frame: score changes after intervention (4 weeks, T1)
The percentage of participants who withdraw from the study.
Feasibility Outcomes: Adherence Rate
Time frame: score changes after intervention (4 weeks, T1)
The percentage of scheduled training sessions attended
Feasibility Outcomes: Longitudinal Retention Rate
Time frame: Post-intervention follow-up assessment (3 months after intervention completion)
The percentage of enrolled participants who complete all follow-up assessments
Feasibility Outcomes: Self-Reported Acceptability
Time frame: score changes after intervention (4 weeks, T1)
Participants will complete a questionnaire at the end of the intervention to evaluate their subjective experience, perceived benefits, and difficulties of the treatment. Items are rated on a 5-point Likert scale ranging from 1 ("low") to 5 ("extremely high"), with higher scores indicating a more positive evaluation or greater perceived benefit/difficulty.
Feasibility Outcomes: Adverse Events
Time frame: score changes after intervention (4 weeks, T1)
The incidence and severity of any adverse events (e.g., falls or excessive fatigue) recorded during the study.
Feasibility Outcomes: Motor Exercise Intensity
Time frame: Monitored during every training session (Up to 4 weeks, from Sessions 1 through 10)
The Borg Rating of Perceived Exertion (RPE) will be used to monitor and quantify physical and cognitive effort. Total score ranges from 6 to 20. Higher scores indicate greater perceived exertion
Feasibility Outcomes: Motor Exercise Exertion
Time frame: Monitored during every training session (Up to 4 weeks, from Sessions 1 through 10)
The Borg Intensity Scale-Exerciser (BIS-E) will be used to quantify exertion. Total score ranges from 0 to 30, higher scores indicate greater perceived balance effort, difficulty, and postural instability during circuit stations.
Feasibility Outcomes: Digital Cognitive Progression Index (NeuronUP Activity Score)
Time frame: Monitored during every training session (Up to 4 weeks, from Sessions 1 through 10)
Digital Cognitive Progression Index (NeuronUP Activity Score) will be used to quantifies session-by-session cognitive performance and adaptive difficulty progression across the 10 training sessions. The score is calculated using NeuronUP's standardized algorithm based on accuracy, total completed phases, and maximum difficulty reached, yielding a score from 0 to 100. Higher scores reflect greater task proficiency and successful progression to higher difficulty levels. This metric serves as an exploratory/feasibility measure of intra-intervention cognitive learning.
13 secondary outcomes
Motor Outcomes: Change in dynamic balance, mobility, and gait
Time frame: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
Motor Outcomes: Change in Gait speed
Time frame: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
Motor Outcomes: Change in Distance Walked
Time frame: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
Motor Outcomes: Change in Dynamic Balance
Time frame: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
Motor Outcomes: Change in Finger motor speed
Time frame: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
Cognitive Outcomes: Change in Global cognitive function
Time frame: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
Cognitive Outcomes: Change in Visual search and processing speed
Time frame: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
Cognitive Outcomes: Change in executive function, cognitive flexibility, and set-shifting.
Time frame: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
Cognitive Outcomes: Change in Information processing speed and attention
Time frame: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
Cognitive Outcomes: Decision-making processing speed and cognitive-motor control
Time frame: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
Cognitive Outcomes: Change in perceptive-motor speed
Time frame: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
Change in Quality of Life
Time frame: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
Change in Fatigue
Time frame: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
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 22 Sep 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined group motor training and individual digital cognitive stimulation in people with PARKINSON DISEASE (Disorder), run by University Hospital of Ferrara 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 8 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 22 Sep 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?
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?
Contact Sofia Straudi, MD, PhD (+390532238720, sofia.straudi@unife.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Outcomes: Eligibility Rate (time frame: Baseline). The study lists 11 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 22 Sep 2026.