An interventional study of Multidisciplinary Intensive Rehabilitation and Muscle-stretching and active mobilization exercises in Parkinson Disease, Biomarkers and Rehabilitation Outcome, sponsored by Fondazione Don Carlo Gnocchi Onlus. Status unknown at 1 site in Italy. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-07-11.
Sponsored by Fondazione Don Carlo Gnocchi Onlus · Not applicable, Interventional, and Treatment
Parkinson's disease (PD) is a progressive neurological disorder characterized by motor and non-motor symptoms such as rigidity, bradykinesia, resting tremor, cognitive and autonomic dysfunctions, gait and balance difficulties.
The impairment of gait, balance and cognitive performances is partially responsive to dopaminergic medications. This emphasizes the importance of non-pharmacological interventions for people with PD (pwPD).
Intensive multidisciplinary motor and cognitive rehabilitation has been proposed as a complementary and effective treatment for managing pwPD.
Several structural and physiological mechanisms have been suggested to underpin exercise-induced neuroplastic changes in PD, such as enhanced synaptic strength and preservation of dopamine neurons. To date, studies on brain changes induced by motor and cognitive exercises in pwPD have been small-scaled and uncontrolled.
Identifying accessible and measurable biomarkers for monitoring the events induced by intensive motor and cognitive rehabilitation program would help in testing the treatment effectiveness and would allow personalization of rehabilitation strategies by predicting patients' responsiveness.
Based on validated clinical assessments of intensive multidisciplinary rehabilitation treatment, the project will test the ability of a new set of biomarkers to evaluate rehabilitative outcomes in a cohort of people with PD.
While pharmacological treatment is helpful in the early stages of the disease, increased attention has been given to rehabilitation that may lead to clinical improvements in motor and non-motor impairments.
Recently synthesized evidence suggests that physical exercise may lead to neuroplastic changes at the functional, structural and molecular levels.
Accessible and measurable biomarkers are needed to monitor the disease progression and the neurobiological changes resulting from pharmacological and rehabilitative treatments, also can be a useful and valuable tool to test rehabilitation effectiveness.
The present project will start from the reliable clinical assessment of rehabilitation effectiveness of an intensive multidisciplinary rehabilitation program, to verify the ability of a new panel of measurable biomarkers to assess neurobiological and functional changes in pwPD.
The purpose of this study is to determine the effects of an intensive multidisciplinary, aerobic, motor-cognitive rehabilitation treatment on accessible and measurable molecular biomarkers (primary outcome); balance and gait performance; aerobic capacity; motor and non-motor symptoms; cognitive functions; neuroimaging biomarker (secondary outcomes) in comparison to an active control group receiving a home-based self-treatment program. Thereafter, the investigators aim to relate the effects seen in motor and "non-motor" behavior to changes in biomolecular and neuroimaging markers.
To achieve this purpose, the study is designed as a Randomized Controlled Trial (RCT) and participants will be recruited at Fondazione Don C. Gnocchi-ONLUS, IRCCS S. Maria Nascente. Seventy-two subjects with a diagnosis of PD in accordance of MDS criteria will be randomly allocated to the experimental (EXP) or control group (CTR).
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 72 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Fondazione Don Carlo Gnocchi Onlus is the lead sponsor of 146 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention of highly challenging motor and cognitive training for 6 consecutive weeks.
Behavioral: Multidisciplinary Intensive Rehabilitation
Home-based self-treatment program for 40 '/ day for 6 consecutive weeks
Behavioral: Muscle-stretching and active mobilization exercises
The rehabilitation program will last for 6 consecutive weeks and involves the execution of 30 sessions, 5 days a week lasting 160 '/ day each (80' motor; 40 'cognitive and 40' speech therapy rehabilitation) for 3 days a week and 180'/ day (80 'motor; 60' cognitive and 40 'speech therapy rehabilitation) for 2 days a week. The EXP group will receive 18 sessions (3 times a week) of treadmill (20 min), balance exercises and functional reinforcement (20 min). The remaining motor sessions will be defined based on the patient's therapeutic needs. The cognitive treatment will be proposed both in traditional mode (3 times a week) and through the support of semi-immersive "Virtual Reality Rehabilitation System" (VRRS) (2 times/week). The VRRS treatment is structured in 2 sessions per week (60 min) for 6 consecutive weeks. The speech therapy program will include clinical and instrumental evaluations and innovative techniques will be used for the treatment (biofeedback with Vitalstim).
The control group subjects will undergo a home-based self-treatment program for 40 '/ day for 6 consecutive weeks consisting of muscle-stretching and active mobilization exercises.
Serum biomarkers in neuron derived extracellular vesicles (NDEVs)
Oligomeric α-synuclein (α-syn) ng/ml; SNARE complex: Syntaxyn-1(STX-1A) (ng/ml), VAMP-2 (ng/ml) and SNAP-25 (ng/ml); Brain-Derived Neurotrophic Factor (BDNF) (ng/ml), pro-BDNF (ng/ml), Glial cell line-derived Neurotrophic factor (GDNF) (ng/ml) Cerebral dopamine neurotrophic factor (CDNF) (ng/ml)
Time frame: 18 weeks
Blood Biomarkers
Pro- \[IL-1β (pg/ml), Tumour Necrosis Factor alpha (TNFα) (pg/ml), Interferon gamma (IFN-γ) (pg/ml), IL-6 (pg/ml), IL-18 (pg/ml)\], Anti-inflammatory (IL-10) (pg/ml) cytokines.
Time frame: 18 weeks
Dynamic Balance
- Timed-Up and -Go Test (TUG); subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again. The Time (seconds) is measured.
Time frame: 18 weeks
Aerobic capacity and endurance
6 Minute Walk Test (6-MWT). The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Time frame: 18 weeks
Gait speed
10 Meter Walk Test (10MWT) assess walking speed in meters per second over a distance of 6 meters.
Time frame: 18 weeks
Strenght
5-Time Sit-To-Stand (5TSTS) is based on the amount of time (in seconds) a patient is able to transfer from a seated to a standing position and back to sitting five times.
Time frame: 18 weeks
Balance
Modified Dynamic Gait Index (mDGI): The mDGI measure balance skills consists of 8 items and results in a total score of 0 to 64.
Time frame: 18 weeks
Gait Analysis
Gait analysis will be assessed using a 9-camera SMART-D motion capture system (BTS, Milano, Italy) in order to measure stride length, step width and length, kinematic data and energy recovery.
Time frame: 18 weeks
Motor and non-motor symptoms
The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I-IV. MDS-UPDRS-PART I ''nonmotor experiences of daily living -nM-EDL-" range: 0-52, 0=better outcome, 52=worse outcome; PART-II ''motor experiences of daily living -M-EDL-'' range: 0-52, 0=better outcome, 52=worse outcome; PART-III ''motor examination'' range: 0-132, 0=better outcome, 132=worse outcome; PART IV ''motor complications'' range: 0-24, 0=better outcome, 24=worse outcome.
Time frame: 18 weeks
Non-Motor symptoms
Non-Motor Symptoms Scale (NMSS) \[range: 0-360, 0=better outcome, 360=worse outcome\];
Time frame: 18 weeks
Fatigue
Parkinson Fatigue Scale (PFS) \[range: 1-5, 1=better outcome, 5=worse outcome\];
Time frame: 18 weeks
Daytime sleepiness
Epworth Sleepiness Scale (ESS) \[range: 0-24, 0=better outcome, 24=worse outcome\];
Time frame: 18 weeks
Sleep quality
Pittsburgh Sleep Quality Index (PSQI) \[range: 0-21, 0=better outcome, 21=worse outcome\];
Time frame: 18 weeks
Rapid eye movement sleep behavior disorder
REM sleep behavior disorder screening questionnaire (RBDSQ) \[range: 0-13, 0=better outcome, 13=worse outcome\].
Time frame: 18 weeks
Autonomic Symptoms
Italian version of the Composite Autonomic Symptoms Score (COMPASS-31) \[weighted score range: 0-100, 0=better outcome, 100=worse outcome\];
Time frame: 18 weeks
Pain Intensity
Numeric Rating Scale (NRS) \[range: 0-10, 0=better outcome, 10=worse outcome\];
Time frame: 18 weeks
Parkinson's disease-specific health related quality of life
The Parkinson Disease Questionnaire (PDQ-39) \[PDQ-39 range: 0%-100%; 0%=better outcome, 100%=worse outcome\].
Time frame: 18 weeks
Global Cognitive Functioning
Montreal Cognitive Assessment (MoCA Test)\[0-30, 0=worse, 30=better outcome\] and Mini-Mental Parkinson (MMP)\[0-32, 0=worse, 32=better outcome\]
Time frame: 18 weeks
Verbal short-term and working memory
Forward and Backward Verbal Span \[0-9, 0=worse, 9=better outcome\]
Time frame: 18 weeks
Verbal episodic memory
Immediate and delayed story recall test \[0-8, 0=worse, 8=better outcome; Oblivion Index range: 0-8, 0=worse, 8=better outcome\]
Time frame: 18 weeks
Visuo-constructional ability
Rey's Figure - Copy \[0-36, 0=worse, 36=better outcome\]
Time frame: 18 weeks
Visuo-spatial memory
Rey's Figure - Recall \[0-36, 0=worse, 36=better outcome\]
Time frame: 18 weeks
Frontal lobe functioning
Frontal Assessment Battery (FAB) \[0-18, 0=worse, 18=better outcome\]
Time frame: 18 weeks
Non-verbal reasoning
Raven Coloured Progressive Matrices (CPM-47) \[0-36, 0=worse, 36=better outcome\]
Time frame: 18 weeks
Extradimensional verbal set-shifting
Alternate Verbal Fluency \[0-∞, 0=worse, ∞=better outcome;Shifting Index 0-1, 0=worse, 1=better outcome\]
Time frame: 18 weeks
Extradimensional non-verbal set-shifting
Trail Making Test (TMT) \[0-∞, 0=worse, ∞=better outcome\]
Time frame: 18 weeks
Speed information processing
Symbol Digit Modalities Test (SDMT) (Oral Version) \[0-120, 0=worse, 120=better outcome\]
Time frame: 18 weeks
Cognitive interference inhibition
Stroop Test-Short Version \[Error: 0-30, 0=better, 30=worse outcome;Time: range: 0-∞, 0=better, ∞=worse outcome\]
Time frame: 18 weeks
IdeoMotor praxis
Gesture Imitation Test (IMA-T) \[0-72, 0=worse, 72=better outcome\]
Time frame: 18 weeks
Language production and non-motor processing speed
Verbal fluency test (phonemic and semantic tasks) \[0-∞, 0=worse, ∞=better outcome\]
Time frame: 18 weeks
Depression
Beck Depression Inventory-II (BDI-II) \[0-63, 0=better, 63=worse outcome\]
Time frame: 18 weeks
Anxiety
State-Trait Anxiety Inventory. Forma Y (STAI-Y) \[20-80; STAI-Y TRAIT ANXIETY range: 20-80; 20=better, 80=worse outcome\]
Time frame: 18 weeks
Apathy
Dimensional Apathy Scale (I-DAS) \[0-72, 0=better, 72=worse outcome\]
Time frame: 18 weeks
Anhedonia
Snaith-Hamilton Pleasure Scale (SHAPS) \[0-14, 0=better, 14=worse outcome\]
Time frame: 18 weeks
Impulsivity
Barratt Impulsiveness Scale-11 (BIS-11) \[30-120, ;30=better, 120=worse outcome\]
Time frame: 18 weeks
Alexithymia
Toronto Alexithymia Scale (TAS-20) \[20-100, 20=better, 100=worse outcome\]
Time frame: 18 weeks
Impulsive Control Disorders
Questionnaire for Impulsive-Compulsive Disorders in Parkinson's disease (QUIP-RS-IT) \[0-112,; 0=better, 112=worse outcome\]
Time frame: 18 weeks
Behavioral disturbances
NeuroPsychiatric Inventory Questionnaire (NPI-Q) \[SE: 0-36, 0=better, 36=worse outcome; ST= 0-60, 0=better, 60=worse outcome\]
Time frame: 18 weeks
Functional disability
Modified Barthel Index (MBI) \[range: 0-100, 0=worse outcome, 100=better outcome\];
Time frame: 18 weeks
Daily self-care activities
Activities of Daily Living (ADL) \[0-6, 0=worse, 6=better outcome\] Instrumental Activities Of Daily Living (IADL) \[0-8, 0=worse, 8=better outcome\]
Time frame: 18 weeks
Caregiver burden
Caregiver Burden Inventory (CBI) \[range 0-96, 0=better, 96=worse outcome\]
Time frame: 18 weeks
Brain functional connectivity
Advanced Magnetic Resonance Imaging (MRI)-3 Tesla protocols, including resting state functional MRI to assess the neural correlates of rehabilitation-induced brain plasticity in pwPD undergoing intensive motor and cognitive rehabilitation.
Time frame: 18 weeks
Cerebral blood flow
Advanced MRI-3 Tesla protocols, including arterial spin labeling (ASL) to assess the neural correlates of rehabilitation-induced brain plasticity in pwPD undergoing intensive motor and cognitive rehabilitation.
Time frame: 18 weeks
Home-based motor activity monitoring
The acquisitions will be obtained from the actigraphs (mounted one on the right wrist and the other on the left wrist).
Time frame: 18 weeks
Plan to share: No
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Started Dec 2020 (actual). Primary completion is estimated for Sep 2023, 33 months after the start.
Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 33 months is above that.
Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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