An interventional study of Combined group motor training and individual digital cognitive stimulation in PARKINSON DISEASE (Disorder), sponsored by University Hospital of Ferrara. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by University Hospital of Ferrara · Not applicable, Interventional, and Treatment
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.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 12 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University Hospital of Ferrara is the lead sponsor of 114 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a 10-session integrated rehabilitation program combining individual digital cognitive stimulation and group functional motor training
Behavioral: Combined group motor training and individual digital cognitive stimulation
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)
Feasibility Outcomes: Eligibility Rate
Calculated as the ratio of eligible patients to the total number of screened patients.
Time frame: Baseline
Feasibility Outcomes: Recruitment Rate
Calculated as the ratio of recruited patients to total eligible patients.
Time frame: Baseline
Feasibility Outcomes: Monthly Recruitment Rate
Defined as the average number of participants enrolled per month.
Time frame: Baseline
Feasibility Outcomes: Drop-out Rate
The percentage of participants who withdraw from the study.
Time frame: score changes after intervention (4 weeks, T1)
Feasibility Outcomes: Adherence Rate
The percentage of scheduled training sessions attended
Time frame: score changes after intervention (4 weeks, T1)
Feasibility Outcomes: Longitudinal Retention Rate
The percentage of enrolled participants who complete all follow-up assessments
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Monitored during every training session (Up to 4 weeks, from Sessions 1 through 10)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
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
The Trail Making Test Part A (TMT-A) will be used to assess visual search abilities 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.
The Trail Making Test Part B (TMT-B) Time will be used to assess 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
The Symbol Digit Modalities Test (SDMT) will be used to assess 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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
Ran from Jun 2026 to primary completion in Aug 2026, 2 months.
Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's 2 months is below that.
Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
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