Effect of a Progressive Treadmill Training Protocol for Parkinson's Disease
NCT05902065, Not applicable, Unknown, University of Florence
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effect of a Progressive Treadmill Training Protocol for Parkinson's Disease | ClinicalTrials.gov |
| NCT number | NCT05902065 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 60 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Florence | ClinicalTrials.gov |
| Conditions | Parkinson Disease, Gait, Festinating, Fall Due to Loss of Equilibrium, Gait, Unsteady, Gait, Shuffling | ClinicalTrials.gov |
| Interventions | AVR Treadmill training with C-Mill, Conventional Treadmill training with C-Mill | ClinicalTrials.gov |
| First posted | 2023-06-13 | ClinicalTrials.gov |
| Last updated | 2023-06-13 | ClinicalTrials.gov |
Registered outcomes 24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Mean change in gait and balance parameters assessed by the Performance Oriented Mobility Assessment - POMA scale (intra-group and between-group comparisons) | T0 (baseline); T1 (end of the treatment - 8 weeks); T2 (3 months after the end of treatment) | The POMA scale is an easily administered task-oriented test that measures an older adult's balance (9 items) and gait (7 items) abilities. Items are scored with a three-point (0-2) or a two points (0-1) scale, where "0" indicates the highest level of impairment and "2" - "1" for dichotomic items - the individual's independence. Total Balance Score = 16; Total Gait Score = 12. | ClinicalTrials.gov |
| Primary | Mean change in motors parameters assessed by the Modified Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part III (intra-group and between-group comparisons) | T0 (baseline); T1 (end of the treatment - 8 weeks); T2 (3 months after the end of treatment) | The MDS-UPDRS part III includes 18 items concerning the motor examination in PD, evaluating different aspects: walking, balance, speech, bradykinesia, tremor, and rigidity. Each item is scored on a five-point ordinal rating scale, ranging from 0 to 4, where "0" indicates normal function and "4" is the highest level of impairment. Some items inclusive of evaluation of a symptom in different parts of the body, e.g on the right side, on the left side, upper and lower limbs). Score range 0-132. | ClinicalTrials.gov |
| Secondary | Correlation between Raman spectra of blood cEVs and primary outcomes after patient stratification | T0 (baseline); T1 (end of the treatment - 8 weeks) | The biological characterization of patients at T0 analyzing cEVs performed by Raman Spectroscopy will provide numerical scores that will be correlated with motor parameters obtained at T1 to identify predictive biomarkers of an outcome measure of rehabilitation | ClinicalTrials.gov |
| Secondary | Changes in individual Raman spectra of blood-derived cEVs before and after treatment | T0 (baseline); T1 (end of the treatment - 8 weeks) | The Raman spectrum of blood-derived cEVs before and after treatment will be compared to identify spectral differences and to monitor the effect of rehabilitation on the spectral biomarker. Changes in the presence/absence of peaks and peaks intensity will be evaluated. | ClinicalTrials.gov |
| Other | Mean changes in walking speed (intra-group and between-group comparisons). | T0 (baseline); T1 (end of the treatment - 8 weeks); T2 (3 months after the end of treatment) | Gait speed (m/s) will be measured at both comfortable and maximum speeds using the Optogait system (http://www.optogait.com/Gait-Phases). | ClinicalTrials.gov |
| Other | Mean changes in step length during walking (intra-group and between-group comparisons). | T1 (end of treatment-8 weeks); T2 (3 months after the end of treatment) | Right and left step length (m) will be measured at both comfortable and maximum speeds using the Optogait system (http://www.optogait.com/Gait-Phases). | ClinicalTrials.gov |
| Other | Mean change in walking endurance assessed with the 6-Minutes Walking Test (6MWT) (intra-group and between-group comparisons). | T0 (baseline); T1 (end of the treatment - 8 weeks); T2 (3 months after the end of treatment) | The distance (m) walked in 6 minutes on a 30 meters walkway will be measured, indicating the greater distance, a better score | ClinicalTrials.gov |
| Other | Mean change in gait adaptability assessed by C-Gait application of C-Mill (intra-group and between-group comparisons) | T1 (end of treatment - 8 weeks); T2 (3 months after the end of treatment) | Walking-adaptability task performance was defined as the percentage of correctly performed steps relative to the projected visual objects in 6 different tasks. C-gait score for each task: Level×2×Performance (%) / 100. The overall assessment score was an average score based on average performance over the six walking-adaptability tasks at the higher level of difficulty, ranging from 0 (poor performance) to 8 (excellent performance). | ClinicalTrials.gov |
| Other | Mean change in freezing during walking assessed by the Freezing Of Gait Questionnaire (FOG-Q) (intra-group and between-group comparisons). | T0 (baseline); T1 (end of the treatment - 8 weeks); T2 (3 months after the end of treatment) | The FOG-Q includes 6 items that inquires about the subject's experiences of freezing during the previous week. Each item use a five-points ordinal scale, ranging from "0" (= absence of symptoms) to "4" (= more severe disturbance). Total score ranges from 0 to 24, and higher scores correspond to more severe freezing. | ClinicalTrials.gov |
| Other | Mean change in postural stability (intra-group and between-group comparisons) | T0 (baseline); T1 (end of the treatment - 8 weeks); T2 (3 months after the end of treatment) | Postural sway assessed with a dynamometric footplate (postural sway in quiet standing with opened/closed eyes). Lower postural sway corresponds to better stability. | ClinicalTrials.gov |
| Other | Mean change in global cognitive functions assessed by the Montreal Cognitive Assessment (MoCA) (intra-group and between-group comparisons) | T0 (baseline); T1 (end of the treatment - 8 weeks); T2 (3 months after the end of treatment) | The MoCA test is used to assess global cognitive functions. A score superior to 18.58 is required for inclusion in the study (Aiello et al, 2021); parallel versions will be administered at different time points (Siciliano et al, 2019). Higher values correspond to better cognition, range of score 0-30. | ClinicalTrials.gov |
| Other | Mean change in global cognitive functions assessed by the Parkinson's disease-cognitive rating scale, italian version (PD-CRS) (intra-group and between-group comparisons) | T0 (baseline); T1 (end of the treatment - 8 weeks); T2 (3 months after the end of treatment) | The PD-CRS is a suitable tool to assess cognition in PD, it evaluates different domains and permits to obtain a cortical and a subcortical score: sum of results in item 1,3,4,5,7,8,9 (range of score 0-104), represents the subcortical score; sum of results in item 2 and 6 (range of score 0-30), represents the cortical score. Higher scores correspond to better cognition | ClinicalTrials.gov |
| Other | Mean change in attention skills assessed by Trail Making Test A and B (TMTA and TMTB) (intra-group and between-group comparisons) | T0 (baseline); T1 (end of the treatment - 8 weeks); T2 (3 months after the end of treatment) | TMTA evaluates sustained attention and the visual search capacity, and TMTB evaluates divided attention. For both tests A and B time and errors will be registered. Slowness and more errors are indicative of lower performances (No range of score). | ClinicalTrials.gov |
| Other | Mean change in executive functions as assessed by the Stroop Test (intra-group and between-group comparisons) | T0 (baseline); T1 (end of the treatment - 8 weeks); T2 (3 months after the end of treatment) | The Stroop test is used to assess executive functions (time and error interference effect). Slowness and higher interference effect indicative of lower performances. (No range of score). | ClinicalTrials.gov |
| Other | Mean change in executive functions as assessed by the Symbol Digit oral version (intra-group and between-group comparisons) | T0 (baseline); T1 (end of the treatment - 8 weeks); T2 (3 months after the end of treatment) | Digit symbol is used for the assessment of attention and working memory. Range of score 0-110. Higher score indicative of better performance | ClinicalTrials.gov |
| Other | Mean change in functional mobility assessed by the Modified Parkinson Activity Scale (MPAS) (intra-group and between-group comparisons) | T0 (baseline); T1 (end of the treatment - 8 weeks); T2 (3 months after the end of treatment) | The MPAS scale evaluates motor skills in activities of daily living. Range of score 0-56; higher score indicative of better functional mobility. | ClinicalTrials.gov |
| Other | Mean change in functional mobility assessed by the Timed up and go test (TUG) (intra-group and between-group comparisons) | T0 (baseline); T1 (end of the treatment - 8 weeks); T2 (3 months after the end of treatment) | The TUG is a general physical performance test used to assess mobility, balance, and gait during walking, turning, and sit-to-stand tasks. Time is recorded during the test; less time indicative of better performances (no range of score). | ClinicalTrials.gov |
| Other | Mean change in functional autonomy assessed by the modified Barthel Index (mBI) (intra-group and between-group comparisons) | T0 (baseline); T1 (end of the treatment - 8 weeks); T2 (3 months after the end of treatment) | mBI is a scale for assessing functional independence in daily life. Range of score 0-100. Lower score corresponds to less independence. | ClinicalTrials.gov |
| Other | Mean change in the quality of life assessed by the Parkinson's Disease Questionnaire Italian version (PDQ-39-IT) (intra-group and between-group comparisons) | T0 (baseline); T1 (end of the treatment - 8 weeks); T2 (3 months after the end of treatment) | PDQ-39 is a self-report questionnaire for assessing the quality of daily life in PD. It includes 39 items assessing how often persons experience difficulty across 8 quality of life dimensions. Each item is scored on a five-point ordinal scale from 0 (=never) to 4 (always). Each dimension total score ranges from 0 (never have difficulty) to 100 (always have difficulty). The summary total score is calculated as the mean of the 8 dimension total scores. A higher score corresponds to a lower quality of life. | ClinicalTrials.gov |
| Other | Mean change in the fear to fall assessed by the Falls efficacy scale, Italian version (FES-I) (intra-group and between-group comparisons) | T0 (baseline); T1 (end of the treatment - 8 weeks); T2 (3 months after the end of treatment) | FES-I is used for the assessment of the fear-of-fall. It includes 16 items rated on a four-point scale from 1 (not confident at all) to 4 (completely confident). Total score ranges from minimum 16 (no concern about falling) to maximum 64 (severe concern about falling). | 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 20
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 686873 | BACKGROUND | PubMed |
| 1991946 | BACKGROUND | PubMed |
| 3944402 | BACKGROUND | PubMed |
| 8915764 | BACKGROUND | PubMed |
| 16796824 | BACKGROUND | PubMed |
| 18356292 | BACKGROUND | PubMed |
| 18691929 | BACKGROUND | PubMed |
| 19025984 | BACKGROUND | PubMed |
| 19836635 | BACKGROUND | PubMed |
| 24021298 | BACKGROUND | PubMed |
| 24125724 | BACKGROUND | PubMed |
| 24221858 | BACKGROUND | PubMed |
| 25515786 | BACKGROUND | PubMed |
| 28224328 | BACKGROUND | PubMed |
| 30088166 | BACKGROUND | PubMed |
| 30637545 | BACKGROUND | PubMed |
| 31648040 | BACKGROUND | PubMed |
| 33828470 | BACKGROUND | PubMed |
| 34313961 | BACKGROUND | PubMed |
| 34656008 | BACKGROUND | PubMed |
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 3
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 |
|---|---|---|
| Stroop Color-Word Test | Other outcome | ConductCognition |
| Trail Making Test A | Other outcome | ConductCognition |
| Trail Making Test B | Other 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)