comparison of different rehabilitation protocols in parkinson's disease with postural instability and gait disorders

Conditions: Parkinson Disease

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 criteria:
inclusion criteria for pd patients: * 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 inclusion criteria for healthy controls: * sex-matched and age-matched (age range: mean age of pd years ± 15 years); * oral and written informed consent to study participation exclusion criteria: * medical conditions or substance abuse that could interfere with cognition; * any major systemic, psychiatric, neurological, visual, and musculoskeletal disturbances or other causes of walking inability; * contraindications to undergoing mri examination; * brain damage at routine mri, including lacunae and extensive cerebrovascular disorders; * denied oral and written informed consent to study participation.

Keywords: parkinson disease gait rehabilitation biomarkers magnetic resonance imaging