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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital of Ferrara

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • 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)

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Combined Motor-Cognitive Training GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility Outcomes: Eligibility Rate

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

Time frame
Baseline
2

Feasibility Outcomes: Recruitment Rate

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

Time frame
Baseline
3

Feasibility Outcomes: Monthly Recruitment Rate

Defined as the average number of participants enrolled per month.

Time frame
Baseline
4

Feasibility Outcomes: Drop-out Rate

The percentage of participants who withdraw from the study.

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

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

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