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

Condition(s) studied

Investigational drug(s) / intervention(s)

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)

Study 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). 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.

Eligibility

Primary outcome measure(s)

• Feasibility Outcomes: Eligibility Rate — Baseline
  Calculated as the ratio of eligible patients to the total number of screened patients.
• Feasibility Outcomes: Recruitment Rate — Baseline
  Calculated as the ratio of recruited patients to total eligible patients.
• Feasibility Outcomes: Monthly Recruitment Rate — Baseline
  Defined as the average number of participants enrolled per month.
• Feasibility Outcomes: Drop-out Rate — score changes after intervention (4 weeks, T1)
  The percentage of participants who withdraw from the study.
• Feasibility Outcomes: Adherence Rate — score changes after intervention (4 weeks, T1)
  The percentage of scheduled training sessions attended
• Feasibility Outcomes: Longitudinal Retention Rate — 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 — 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 — 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 — 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 — 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) — 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.

Trial sites (1)

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