Ferrara University Hospital
Ferrara, FE, 44124, Italy
Location status: Recruiting
Location contact
Andrea Baroni, Physiotherapist, PhD
SUB_INVESTIGATOR
Gaia Palma, PhD student, Psychologist
SUB_INVESTIGATOR
Sofia Straudi, MD, PhD
CONTACT
NCT Number: NCT07833748
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Ferrara, FE, 44124, Italy
Location status: Recruiting
Andrea Baroni, Physiotherapist, PhD
SUB_INVESTIGATOR
Gaia Palma, PhD student, Psychologist
SUB_INVESTIGATOR
Sofia Straudi, MD, PhD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline
Calculated as the ratio of eligible patients to the total number of screened patients.
Time frame: Baseline
Calculated as the ratio of recruited patients to total eligible patients.
Time frame: Baseline
Defined as the average number of participants enrolled per month.
Time frame: score changes after intervention (4 weeks, T1)
The percentage of participants who withdraw from the study.
Time frame: score changes after intervention (4 weeks, T1)
The percentage of scheduled training sessions attended
Time frame: Post-intervention follow-up assessment (3 months after intervention completion)
The percentage of enrolled participants who complete all follow-up assessments
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.
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.
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
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.
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.
Time frame: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
Contact information is provided by the study sponsor or research team.
University Hospital of Ferrara
Other
Acronym: P_Feasibility
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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