Effect of a Progressive Treadmill Training Protocol for Parkinson's Disease
NCT ID: NCT05902065
Last Updated: 2023-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
60 participants
INTERVENTIONAL
2022-07-06
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Clinical, neuropsychological, and instrumental variables will be collected at baseline (T0), at the end of the treatment (T1), and 3 months after the end of treatment (T2). At 6 months after the end of treatment (T3), a phone interview will be performed. Both within-group and between-group analyses will be conducted. Biosamples will be collected at baseline (T0) and at the end of treatment (T1).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Augmented Reality Treadmill Training in Patients With Parkinson's Disease
NCT04108741
Feasibility and Effectiveness of Virtual Reality & Use of Body Weight Support Treadmill Training in Parkinson's Disease
NCT02516644
A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson
NCT04117737
RCT on Telerehabilitation Efficacy in Parkinson's Disease
NCT05842577
Effects of a Treadmill Gait Training Protocol in a Gamified Virtual Reality Environment With tDCS in Parkinson's Disease
NCT05243394
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The sponsor of the study is the Department of Clinical and Experimental Medicine, University of Florence, Italy; the study will be performed at "Struttura Organizzativa Dipartimentale (SOD) di Riabilitazione Generale- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Fondazione Don Carlo Gnocchi, Florence".
Collaborators for external services:
* Movement Analysis Laboratory at IRCCS Don Carlo Gnocchi Florence
* Laboratory of Nanomedicine and Clinical Biophotonics (LABION) at IRCCS Don Carlo Gnocchi Milan
Study start and length: study started on 6 July 2022 and will terminate on December 2023.
Study length for single participant 8 months: enrollment and baseline assessment (T0), treatment (2 months duration), end-of-treatment assessment (T1), follow-up assessment at 3 months after the end of treatment (T2), telephone interview at 6 months after the end of treatment.
Primary objective: to compare the effects of an integrated rehabilitation intervention using a new treadmill training that includes AVR applications, versus a conventional treadmill-based intervention in patients with PD (Hoehn and Yahr stage II-III) affected by walking and or balance disorders.
Secondary objective: to stratify PD patients based on their biological profile and identify predictive biomarkers and biomarkers indicative of an outcome measure of rehabilitation.
Description of the intervention. The intervention includes three sessions per week for 8 weeks. The intervention will be delivered during the "on" time of patients, every day at the same time.
The experimental and the conventional treatments are planned to be progressive and customizable to the participant's level of performance:
* progression in gait speed: gait speed is set at 80% of the individual's overground walking speed at the beginning of training, and will be weekly progressively increased to a maximum of 120%
* progression in trial duration: at the beginning of training, the duration is set at 25 minutes, including 5 slots of exercises lasting 5 minutes, with a 4-minute rest between each slot; every two weeks it will be increased by 1 minute per slot, reaching a maximal duration of 45 minutes in the last two weeks of treatment;
* progression in trial difficulty (only for the experimental group): the protocol has 5 difficulty levels for each C-Mill application, and the transition among levels is set at 80% success achievement.
Safety measures: participants will exercise wearing an anti-fall device and heart rate control; when the heart rate exceeds the safety threshold (set at 75% of HRmax, i.e., 220-age for males; 200-age for females), the treadmill speed will be lowered until the parameter is normalized.
Motek's C-Mill is a newly developed treadmill for gait and balance assessment and training that will be used for the study in both groups in a safe way (with an anti-fall device application and heart rate control). It is a treadmill sensor inclusive of a force platform. The patient is instructed to avoid using the side support bars during the training. The AVR applications of the C-Mill included in the training protocol are "nature island", "stepping stones", "walking area", "obstacles avoidance", and "tracks". These applications train balance and changes in walking speed, promote gait adaptation strategies and strategies to overcome freezing of gait, in a safe and controlled environment. Moreover, feedback to promote proper walking is provided (by physiotherapists and applications) including feedback on gait parameters such as stride symmetry, stride length, and cadence.
Visits planning and assessment timing Clinical, neuropsychological, and instrumental variables will be collected at baseline (T0), at the end of the treatment (T1), and 3 months after the end of treatment (T2). At 6 months after the end of treatment (T3) a phone interview will be performed.
All the assessments will be performed at each time point (T0, T1, T2) with some exceptions: automatic acquisition of gait parameters using C-Mill in C-Gait mode will be collected only at T1 and T2; at the end of treatment (T1), a 5-point Likert scale will also be administered to register patient satisfaction; during the phone interview at T3 only the falls questionnaire will be administered.
All visits will be planned in the "on" time of patients. Pharmacological treatments should be stable until T1.
Definition of adherence: adherence to the intervention will be considered sufficient if the patient respects the times and methods of execution of the rehabilitation treatment indicated in the intervention scheme. Missing up to 5 sessions is allowed, and lost sessions will be possibly recovered at the end of treatment. In case of discontinuation of treatment (one or more sessions missed), the treatment will be restarted with the gait speed, trial duration, and level of difficulty used in the last completed session. Participants who will miss more than 5 sessions will be considered dropouts.
Sample size. The G\*Power software was used to estimate the sample size. From the literature, previous studies that aimed to evaluate the effects of treadmill training other than routine (partial weight-supported treadmill training) on patients with PD had observed a high effect size (ɳ2=0.737). In our estimate, a medium effect size (f=0.25) was conservatively chosen. Assuming a statistical power of 95% and an α=0.05, the resulting sample is 22 subjects per arm. To compensate for possible drop-outs, estimated at around 35%, the enrollment of a further 16 patients is appropriate, 8 per treatment arm, reaching an estimate of 30 subjects per group.
Data analysis. For all data, the distribution will be assessed using the Kolmogorov-Smirnov test (assuming the presence of normal distribution when p\>0.05). Data will then be summarised as mean and standard deviation, median and interquartile range, or absolute and percentage frequency, as appropriate. The two groups will be compared at baseline to explore significant differences in clinical and demographic variables. Both within- and between-groups analysis will be conducted to assess the effects of the treatments delivered, for both primary and secondary outcome measures. Specifically, a repeated measures ANOVA will be used with a within-factor (Time of assessment) and a between-factor (Group). Statistical analysis will be conducted using the software International Business Machines Corporation (IBM) Statistical Package for the Social Sciences (SPSS) v28.
The acquired Raman spectra will be analyzed by multivariate Principal Component Analysis - Linear Discriminant Analysis (PCA-LDA) classification. PCA will reduce the number of variables into principal components, which will be used to build the LDA model. The model will be built to discriminate clinical improvement detected as quantifiable change on clinical scales, defined based on the minimum clinically important difference, when available from the literature. Sensitivity, specificity and accuracy of the predicting model based on spectra data will be assessed. In addition, correlation analysis will be conducted to evaluate the association between spectral data and change on clinical scales recorded between the beginning and the end of the treatment. Statistical analysis of the Raman data will be performed using Origin2021 software.
Univariate analysis models will be applied to select the best prognostic markers of clinical improvement to be included in the multivariate model. For all analyses, statistical significance will be set at p\<0.05
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Blindness will be ensured by the modality and timing of assessments at T0, T1, and T2 that will be conducted at times other than treatment and by evaluators not involved in the treadmill training. Blinding will be removed if requested by the participant at the end of the study and in case of undesirable effects.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AVR Treadmill training with C-Mill
Participants (N=30) will undergo the AVR Treadmill training intervention with 5 AVR applications named "Nature Island", "stepping stones", "walking area": "obstacles avoidance", and "track".
AVR Treadmill training with C-Mill
The protocol will include three sessions per week for 8 weeks of gait training using C-Mill with AVR applications. An anchoring system will prevent possible falls, activities will be stopped on patient request, or when a heart rate considered safe will be exceeded. The patient will be supervised by a physical therapist and asked not to use lateral bars. Treatment is planned to be progressive and will be individualized to the participant's level of performance. Progression in gait speed: at the training start, gait speed will be set at 80% of the individual's overground walking speed and weekly increased by 10%, to a maximum of 120%; progression in trial duration: at the training start the duration will be set at 25' and every two weeks increased by 5'; the maximum duration of a session will reach 45'; progression in difficulty: the protocol has 5 levels for each AVR application, and the transition among levels will be set at 80% success achievement.
Conventional Treadmill training with C-Mill
Participants (N=30) will undergo the "Traditional Treadmill" intervention.
Conventional Treadmill training with C-Mill
The protocol will include three sessions per week for 8 weeks of gait training using C-Mill without AVR applications, walking on the treadmill. An anchoring system will prevent possible falls, activities will be stopped on patient request, or when a heart rate considered safe will be exceeded. All sessions will be supervised by a physical therapist, who will give guidance and standardized cues on walking patterns (e.g., step length). The patient will be asked not to use the lateral bars. Treatment is planned to be progressive and will be individualized to the participant's level of performance: progression in gait speed: at the training start, gait speed will be set at 80% of the individual's overground walking speed and weekly increased by 10%, to a maximum of 120%; progression in trial duration: at the training start the duration will be set at 25' and every two weeks increased by 5'; the maximum duration of a session will reach 45'.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AVR Treadmill training with C-Mill
The protocol will include three sessions per week for 8 weeks of gait training using C-Mill with AVR applications. An anchoring system will prevent possible falls, activities will be stopped on patient request, or when a heart rate considered safe will be exceeded. The patient will be supervised by a physical therapist and asked not to use lateral bars. Treatment is planned to be progressive and will be individualized to the participant's level of performance. Progression in gait speed: at the training start, gait speed will be set at 80% of the individual's overground walking speed and weekly increased by 10%, to a maximum of 120%; progression in trial duration: at the training start the duration will be set at 25' and every two weeks increased by 5'; the maximum duration of a session will reach 45'; progression in difficulty: the protocol has 5 levels for each AVR application, and the transition among levels will be set at 80% success achievement.
Conventional Treadmill training with C-Mill
The protocol will include three sessions per week for 8 weeks of gait training using C-Mill without AVR applications, walking on the treadmill. An anchoring system will prevent possible falls, activities will be stopped on patient request, or when a heart rate considered safe will be exceeded. All sessions will be supervised by a physical therapist, who will give guidance and standardized cues on walking patterns (e.g., step length). The patient will be asked not to use the lateral bars. Treatment is planned to be progressive and will be individualized to the participant's level of performance: progression in gait speed: at the training start, gait speed will be set at 80% of the individual's overground walking speed and weekly increased by 10%, to a maximum of 120%; progression in trial duration: at the training start the duration will be set at 25' and every two weeks increased by 5'; the maximum duration of a session will reach 45'.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Hoehn and Yahr Stage II-III
* Age\>18 years
* One fall in the past 3 months/presence of postural instability /gait disturbance
* Able to walk for at least 5 minutes without assistance
* Stable drug therapy by at least 1 month
* Willingness to participate in the study, ability to understand and willingness to sign informed consent
Exclusion Criteria
* Cognitive impairment capable of interfering with rehabilitation procedures, estimated as a score less than 18.58 at the Montreal Cognitive Assessment (MoCA), row score corrected according to Aiello et al, 2022
* Hallucinations
* Psychiatric disorder not controlled by current drug therapy
* Alcohol/drug use
* Uncompensated visual/auditory deficit that limits enjoyment of the cues provided by the AVR
* Communication deficit from any cause that impairs understanding of the task and the objectives of the intervention
* Recurrent episodes of severe orthostatic hypotension
* Severe cardiovascular diseases
* Patient undergoing other experimental protocol (patients regularly undergoing physical activity or sport will not be excluded)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fondazione Don Carlo Gnocchi Onlus
OTHER
University of Florence
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Francesca Cecchi
Associate Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
IRCCS Fondazione Don Gnocchi Firenze
Florence, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Gualerzi A, Picciolini S, Carlomagno C, Terenzi F, Ramat S, Sorbi S, Bedoni M. Raman profiling of circulating extracellular vesicles for the stratification of Parkinson's patients. Nanomedicine. 2019 Nov;22:102097. doi: 10.1016/j.nano.2019.102097. Epub 2019 Oct 21.
Erdfelder, E., Faul, F., & Buchner, A. (1996). GPOWER: A general power analysis program. Behavior research methods, instruments, & computers, 28(1), 1-11.
Ganesan M, Sathyaprabha TN, Gupta A, Pal PK. Effect of partial weight-supported treadmill gait training on balance in patients with Parkinson disease. PM R. 2014 Jan;6(1):22-33. doi: 10.1016/j.pmrj.2013.08.604. Epub 2013 Sep 8.
Tinetti ME. Performance-oriented assessment of mobility problems in elderly patients. J Am Geriatr Soc. 1986 Feb;34(2):119-26. doi: 10.1111/j.1532-5415.1986.tb05480.x. No abstract available.
Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.
Tambasco N, Simoni S, Eusebi P, Ripandelli F, Brahimi E, Sacchini E, Nigro P, Marsili E, Calabresi P. The validation of an Italian version of the Freezing of Gait Questionnaire. Neurol Sci. 2015 May;36(5):759-64. doi: 10.1007/s10072-014-2037-5. Epub 2014 Dec 17.
Downie WW, Leatham PA, Rhind VM, Wright V, Branco JA, Anderson JA. Studies with pain rating scales. Ann Rheum Dis. 1978 Aug;37(4):378-81. doi: 10.1136/ard.37.4.378.
Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
Keus SH, Nieuwboer A, Bloem BR, Borm GF, Munneke M. Clinimetric analyses of the Modified Parkinson Activity Scale. Parkinsonism Relat Disord. 2009 May;15(4):263-9. doi: 10.1016/j.parkreldis.2008.06.003. Epub 2008 Aug 8.
Galeoto G, Colalelli F, Massai P, Berardi A, Tofani M, Pierantozzi M, Servadio A, Fabbrini A, Fabbrini G. Quality of life in Parkinson's disease: Italian validation of the Parkinson's Disease Questionnaire (PDQ-39-IT). Neurol Sci. 2018 Nov;39(11):1903-1909. doi: 10.1007/s10072-018-3524-x. Epub 2018 Aug 7.
Ruggiero C, Mariani T, Gugliotta R, Gasperini B, Patacchini F, Nguyen HN, Zampi E, Serra R, Dell'Aquila G, Cirinei E, Cenni S, Lattanzio F, Cherubini A. Validation of the Italian version of the falls efficacy scale international (FES-I) and the short FES-I in community-dwelling older persons. Arch Gerontol Geriatr. 2009;49 Suppl 1:211-9. doi: 10.1016/j.archger.2009.09.031.
Molino-Lova R, Sofi F, Pasquini G, Gori A, Vannetti F, Abbate R, Gensini GF, Macchi C; Mugello Study Working Group. The Mugello study, a survey of nonagenarians living in Tuscany: design, methods and participants' general characteristics. Eur J Intern Med. 2013 Dec;24(8):745-9. doi: 10.1016/j.ejim.2013.09.008. Epub 2013 Oct 11.
Ghisi M at al 2006, Beck Depression Inventory - II (BDI-II) Manuale. Firenze: O.S. Organizzazioni Speciali
Santangelo G, Barone P, Abbruzzese G, Ferini-Strambi L, Antonini A; IRIS Study Group. Validation of the Italian version of Parkinson's disease-cognitive rating scale (PD-CRS). Neurol Sci. 2014 Apr;35(4):537-44. doi: 10.1007/s10072-013-1538-y. Epub 2013 Sep 25.
Giovagnoli AR, Del Pesce M, Mascheroni S, Simoncelli M, Laiacona M, Capitani E. Trail making test: normative values from 287 normal adult controls. Ital J Neurol Sci. 1996 Aug;17(4):305-9. doi: 10.1007/BF01997792.
Nocentini U, Giordano A, Di Vincenzo S, Panella M, Pasqualetti P. The Symbol Digit Modalities Test - Oral version: Italian normative data. Funct Neurol. 2006 Apr-Jun;21(2):93-6.
Aiello EN, Gramegna C, Esposito A, Gazzaniga V, Zago S, Difonzo T, Maddaluno O, Appollonio I, Bolognini N. The Montreal Cognitive Assessment (MoCA): updated norms and psychometric insights into adaptive testing from healthy individuals in Northern Italy. Aging Clin Exp Res. 2022 Feb;34(2):375-382. doi: 10.1007/s40520-021-01943-7. Epub 2021 Jul 27.
Chen ZY, Yan HJ, Qi L, Zhen QX, Liu C, Wang P, Liu YH, Wang RD, Liu YJ, Fang JP, Su Y, Yan XY, Liu AX, Xi J, Fang B. C-Gait for Detecting Freezing of Gait in the Early to Middle Stages of Parkinson's Disease: A Model Prediction Study. Front Hum Neurosci. 2021 Mar 22;15:621977. doi: 10.3389/fnhum.2021.621977. eCollection 2021.
Steffen T, Seney M. Test-retest reliability and minimal detectable change on balance and ambulation tests, the 36-item short-form health survey, and the unified Parkinson disease rating scale in people with parkinsonism. Phys Ther. 2008 Jun;88(6):733-46. doi: 10.2522/ptj.20070214. Epub 2008 Mar 20.
Siciliano M, Chiorri C, Passaniti C, Sant'Elia V, Trojano L, Santangelo G. Comparison of alternate and original forms of the Montreal Cognitive Assessment (MoCA): an Italian normative study. Neurol Sci. 2019 Apr;40(4):691-702. doi: 10.1007/s10072-019-3700-7. Epub 2019 Jan 14.
Santangelo G, Lagravinese G, Battini V, Chiorri C, Siciliano M, Abbruzzese G, Vitale C, Barone P. The Parkinson's Disease-Cognitive Rating Scale (PD-CRS): normative values from 268 healthy Italian individuals. Neurol Sci. 2017 May;38(5):845-853. doi: 10.1007/s10072-017-2844-6. Epub 2017 Feb 21.
Wang Y, Gao L, Yan H, Jin Z, Fang J, Qi L, Zhen Q, Liu C, Wang P, Liu Y, Wang R, Liu Y, Su Y, Liu A, Fang B. Efficacy of C-Mill gait training for improving walking adaptability in early and middle stages of Parkinson's disease. Gait Posture. 2022 Jan;91:79-85. doi: 10.1016/j.gaitpost.2021.10.010. Epub 2021 Oct 11.
Related Links
Access external resources that provide additional context or updates about the study.
gait parameters derived from Optogait assessment
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VIRTREAD-PD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.