Biomarkers of Rehabilitation Outcome in Patients With Parkinson's Disease: Effect of a Customized Protocol on Treadmill Training With and Without Augmented Virtual Reality Application, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Mean change in gait and balance parameters assessed by the Performance Oriented Mobility Assessment - POMA scale (intra-group and between-group comparisons)
研究概览
简要总结
The primary objective of this single-center, no-profit, longitudinal interventional randomized controlled, single-blind trial is to compare the effects of 2 different treadmill training treatments using C-Mill: the experimental one, endowed with augmented virtual reality (AVR) applications, versus the conventional one, the standard treadmill training in PD patients with gait and or balance disturbances. The main questions the study aims to answer are 1) Is the experimental treatment more effective than the conventional one? 2) Is it possible to identify predictive and indicative biomarkers of an outcome measure of rehabilitation using extracellular vesicles (cEVs) assessed by Raman spectroscopy? Participants will be randomized into two groups: the experimental group that will receive the experimental intervention, and the control group that will receive the conventional intervention. Both groups will train three times per week for 8 weeks, the first session starting from 25 minutes (25'). The experimental and the conventional treatments are planned to be progressive and will be individualized to the participant's level of performance.
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).
详细描述
Study design: single-center, no-profit, randomized controlled single-blind trial (clinicians that assessed the effect of the interventions will be blind), with an active comparator. The study reflects the design of superiority of the experimental treatment versus the standard one. The treatment arm will be assigned by randomization. The results obtained with the 2 treatments will be compared.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome Assessors will be blinded regarding treatment assignment, including clinicians assessing the eligibility of patients and enrolling them in the study; the evaluators (neurologist, physiatrist, psychologist, physical therapists, engineers, laboratory staff).
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson's disease according to the diagnostic (POSTUMA 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
排除标准
- •Other pathology concurrent with gait disturbance (symptomatic arthritis involving hip/knee/ankle, stroke outcomes, severe polyneuropathy)
- •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)
结局指标
主要结局
Mean change in gait and balance parameters assessed by the Performance Oriented Mobility Assessment - POMA scale (intra-group and between-group comparisons)
时间窗: 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.
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)
时间窗: 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.
次要结局
- Changes in individual Raman spectra of blood-derived cEVs before and after treatment(T0 (baseline); T1 (end of the treatment - 8 weeks))
- Correlation between Raman spectra of blood cEVs and primary outcomes after patient stratification(T0 (baseline); T1 (end of the treatment - 8 weeks))
研究者
Francesca Cecchi
Associate Professor
University of Florence