Multiparametric Biomarkers to Predict the Response to Different Protocols of Motor-cognitive Rehabilitation in Parkinson's Disease Subjects With Postural Instability and Gait Disorders

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The aim of the study is to compare the effects of 2 different dosages and modalities of motor-cognitive rehabilitation in Parkinson's disease with postural instability and gait disorders (PD-PIGD) on clinical features, neuroimaging and blood-based biomarkers at short-term (2 months) and long-term (7 months) follow-up. Fifty subjects with PD-PIGD will be randomized in 2 training groups: DUAL-TASK+AOT-MI and the DUAL-TASK groups. The DUAL-TASK+AOT-MI group will perform a dual-task gait/balance training consisting of action observation training (AOT) and motor imagery (MI) combined with practicing the observed-imagined exercises; DUAL-TASK group will perform the same exercises combined with watching landscape videos. The training will last 6 weeks, 3 times/week, 1 hour per session. Before and after training (W6), all the patients will undergo neurological, gait/balance, cognitive/behavioral, magnetic resonance imaging (MRI) and serum biomarkers evaluations. Neurological, gait/balance, cognitive/behavioral assessments and serum biomarkers will be also repeated at the 14-week follow-up (W14) to assess maintenance of results. Patients of both DUAL-TASK+AOT-MI and DUAL-TASK groups will be further randomized to repeat the training (6 weeks, 3 times/week, 1 hour each session) starting at W14 (DUAL-TASK+AOT-MI\_DOUBLE and DUAL-TASK\_DOUBLE groups). After six weeks (W20) all the subjects repeating the training will be evaluated (neurological, gait/balance, cognitive/behavioral assessments). At 28-week follow-up (W28), the whole sample of patients will be assessed with neurological, gait/balance, cognitive/behavioral, MRI and serum biomarkers evaluations. All MRI scans will be acquired at least 12 hours after last dopaminergic therapy administration to mitigate the pharmacological effects on neural activity. Twenty age- and sex-matched healthy controls will be recruited to perform gait/balance and cognitive/behavioral assessments, blood sample and brain MRI acquisition at baseline. The secondary aims of the study are to define the neuroimaging and blood-based biomarkers of PD-PIGD patients presenting different clinical features (e.g. presence of mild cognitive impairment, freezing of gait, falls and mood disturbances) and to evaluate the role of blood-based and neuroimaging biomarkers, together with clinical characteristics, in predicting the response to different dosages of rehabilitation in PD-PIGD throughout the development of a machine-learning algorithm.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 85
Healthy Volunteers: t
View:

• 45 years ≤ age ≤ 85 years;

• Idiopathic PD according to the Movement Disorders Society (MDS) diagnostic criteria

• Hoehn \& Yahr (H\&Y) score \<= 4

• PIGD phenotype

• Stable dopaminergic medication for at least 4 weeks and without any changes during the observation period (28 weeks)

• No dementia according to Litvan's criteria and Mini-Mental Status Examination score (MMSE) \>= 24

• No significant tremor/involuntary movements that could determine artifacts during the MRI acquisition

• Oral and written informed consent to study participation

• sex-matched and age-matched (age range: mean age of PD years ± 15 years);

• oral and written informed consent to study participation

Locations
Other Locations
Italy
IRCCS San Raffaele
RECRUITING
Milan
Neurology Unit, Azienda Ospedaliera Universitaria Integrata di Verona
NOT_YET_RECRUITING
Verona
Contact Information
Primary
Elisabetta Sarasso, MSc, PT
sarasso.elisabetta@hsr.it
0226434685
Backup
Roberta Balestrino, MD
balestrino.roberta@hstr.it
0226436168
Time Frame
Start Date: 2023-04-30
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 80
Treatments
Experimental: DUAL-TASK+AOT-MI
Dual-task gait and balance training with cognitive facilitations (action observation and motor imagery) for six weeks.
Active_comparator: DUAL-TASK
Dual-task gait and balance training with vision of landscape videos for six weeks.
Experimental: DUAL-TASK+AOT-MI_DOUBLE
Dual-task gait and balance training with cognitive facilitations (action observation and motor imagery) repeated two times (twelve weeks: 6 + 6).
Active_comparator: DUAL-TASK_DOUBLE
Dual-task gait and balance training with vision of landscape videos repeated two times (twelve weeks: 6 + 6).
No_intervention: Healthy subjects
Age- and sex-matched healthy subjects recruited to compare gait, neuropsychological, serum and functional magnetic resonance imaging characteristics at baseline.
Related Therapeutic Areas
Sponsors
Leads: Prof. Massimo Filippi
Collaborators: Azienda Ospedaliera Universitaria Integrata Verona

This content was sourced from clinicaltrials.gov

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