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NCT Number: NCT07833748

Integrated Motor-Cognitive Training in Parkinson's Disease: A Feasibility 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

[email protected]

0532238720

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Concomitant major neurological or psychiatric disorders
  • Severe cardio-pulmonary, renal, or hepatic diseases
  • Changes in baseline pharmacological therapy within 3 months prior to enrollment

Treatment and study plan

Combined group motor training and individual digital cognitive stimulation

Behavioral

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)

Primary outcomes

  1. Feasibility Outcomes: Eligibility Rate

    Time frame: Baseline

    Calculated as the ratio of eligible patients to the total number of screened patients.

  2. Feasibility Outcomes: Recruitment Rate

    Time frame: Baseline

    Calculated as the ratio of recruited patients to total eligible patients.

  3. Feasibility Outcomes: Monthly Recruitment Rate

    Time frame: Baseline

    Defined as the average number of participants enrolled per month.

  4. Feasibility Outcomes: Drop-out Rate

    Time frame: score changes after intervention (4 weeks, T1)

    The percentage of participants who withdraw from the study.

  5. Feasibility Outcomes: Adherence Rate

    Time frame: score changes after intervention (4 weeks, T1)

    The percentage of scheduled training sessions attended

  6. 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

  7. 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.

  8. 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.

  9. 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

  10. 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.

  11. 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.

Secondary outcomes

  1. 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)

    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.

  2. Motor Outcomes: Change in Gait speed

    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.

  3. Motor Outcomes: Change in Distance Walked

    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.

  4. Motor Outcomes: Change in Dynamic Balance

    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.

  5. Motor Outcomes: Change in Finger motor speed

    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.

  6. Cognitive Outcomes: Change in Global cognitive function

    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).

  7. 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)

    The Trail Making Test Part A (TMT-A) will be used to assess visual search abilities and processing speed.

  8. 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)

    The Trail Making Test Part B (TMT-B) Time will be used to assess executive function, cognitive flexibility, and set-shifting.

  9. 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)

    The Symbol Digit Modalities Test (SDMT) will be used to assess information processing speed and attention.

  10. 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)

    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.

  11. Cognitive Outcomes: Change in perceptive-motor speed

    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.

  12. Change in Quality of Life

    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.

  13. Change in Fatigue

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sofia Straudi, MD, PhD

CONTACT

[email protected]

+390532238720

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Registry information

Acronym: P_Feasibility

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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