Intensive Multidisciplinary Rehabilitation and Biomarkers in Parkinson's Disease
NCT05452655, Not applicable, Unknown, Fondazione Don Carlo Gnocchi ETS
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Intensive Multidisciplinary Rehabilitation and Biomarkers in Parkinson's Disease | ClinicalTrials.gov |
| NCT number | NCT05452655 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 72 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Fondazione Don Carlo Gnocchi ETS | ClinicalTrials.gov |
| Conditions | Parkinson Disease, Biomarkers, Rehabilitation Outcome, Gait Disorders, Neurologic, Parkinsonian Disorders, Basal Ganglia Diseases, Central Nervous System Diseases, Movement Disorders, Synucleinopathies, Neurodegenerative Diseases, Cognitive Impairment, Gait Analysis, Pathologic Processes, Magnetic Resonance Imaging, Physiotherapy | ClinicalTrials.gov |
| Interventions | Multidisciplinary Intensive Rehabilitation, Muscle-stretching and active mobilization exercises | ClinicalTrials.gov |
| First posted | 2022-07-11 | ClinicalTrials.gov |
| Last updated | 2022-07-11 | ClinicalTrials.gov |
Registered outcomes 44
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Serum biomarkers in neuron derived extracellular vesicles (NDEVs) | 18 weeks | 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) | ClinicalTrials.gov |
| Primary | Blood Biomarkers | 18 weeks | 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. | ClinicalTrials.gov |
| Secondary | Dynamic Balance | 18 weeks | \- 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. | ClinicalTrials.gov |
| Secondary | Aerobic capacity and endurance | 18 weeks | 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. | ClinicalTrials.gov |
| Secondary | Gait speed | 18 weeks | 10 Meter Walk Test (10MWT) assess walking speed in meters per second over a distance of 6 meters. | ClinicalTrials.gov |
| Secondary | Strenght | 18 weeks | 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. | ClinicalTrials.gov |
| Secondary | Balance | 18 weeks | Modified Dynamic Gait Index (mDGI): The mDGI measure balance skills consists of 8 items and results in a total score of 0 to 64. | ClinicalTrials.gov |
| Secondary | Gait Analysis | 18 weeks | 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. | ClinicalTrials.gov |
| Secondary | Motor and non-motor symptoms | 18 weeks | 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. | ClinicalTrials.gov |
| Secondary | Non-Motor symptoms | 18 weeks | Non-Motor Symptoms Scale (NMSS) \[range: 0-360, 0=better outcome, 360=worse outcome\]; | ClinicalTrials.gov |
| Secondary | Fatigue | 18 weeks | Parkinson Fatigue Scale (PFS) \[range: 1-5, 1=better outcome, 5=worse outcome\]; | ClinicalTrials.gov |
| Secondary | Daytime sleepiness | 18 weeks | Epworth Sleepiness Scale (ESS) \[range: 0-24, 0=better outcome, 24=worse outcome\]; | ClinicalTrials.gov |
| Secondary | Sleep quality | 18 weeks | Pittsburgh Sleep Quality Index (PSQI) \[range: 0-21, 0=better outcome, 21=worse outcome\]; | ClinicalTrials.gov |
| Secondary | Rapid eye movement sleep behavior disorder | 18 weeks | REM sleep behavior disorder screening questionnaire (RBDSQ) \[range: 0-13, 0=better outcome, 13=worse outcome\]. | ClinicalTrials.gov |
| Secondary | Autonomic Symptoms | 18 weeks | Italian version of the Composite Autonomic Symptoms Score (COMPASS-31) \[weighted score range: 0-100, 0=better outcome, 100=worse outcome\]; | ClinicalTrials.gov |
| Secondary | Pain Intensity | 18 weeks | Numeric Rating Scale (NRS) \[range: 0-10, 0=better outcome, 10=worse outcome\]; | ClinicalTrials.gov |
| Secondary | Parkinson's disease-specific health related quality of life | 18 weeks | The Parkinson Disease Questionnaire (PDQ-39) \[PDQ-39 range: 0%-100%; 0%=better outcome, 100%=worse outcome\]. | ClinicalTrials.gov |
| Secondary | Global Cognitive Functioning | 18 weeks | Montreal Cognitive Assessment (MoCA Test)\[0-30, 0=worse, 30=better outcome\] and Mini-Mental Parkinson (MMP)\[0-32, 0=worse, 32=better outcome\] | ClinicalTrials.gov |
| Secondary | Verbal short-term and working memory | 18 weeks | Forward and Backward Verbal Span \[0-9, 0=worse, 9=better outcome\] | ClinicalTrials.gov |
| Secondary | Verbal episodic memory | 18 weeks | Immediate and delayed story recall test \[0-8, 0=worse, 8=better outcome; Oblivion Index range: 0-8, 0=worse, 8=better outcome\] | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 2
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Matrix Reasoning | Secondary outcome | ConductCognition |
| Short Story Recall | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)