Effects of Biofeedback Footwear in Parkinson's Disease: Assessment of Functional Motor Abilities and Locomotion
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Harmonic Ratio (HR)
研究概览
简要总结
The study aims to verify whether the use of a specific footwear providing increased plantar feedback (plantar feedback shoes) could improve gait parameters, postural control and functional performances in people with Parkinson's disease.
Specifically, the aims are:
- To evaluate the acute effect of plantar feedback shoes, by comparing gait, functional and postural performances in three conditions: neutral shoes, barefoot, and plantar feedback shoes;
- To evaluate the effect of four weeks of plantar feedback shoes, on gait, functional and postural performances.
Participants will undergo a comprehensive neurological examination, with administration of disease-specific scales (UPDRS III part 3, NFOG-q, LEDD, DASS-21). At each assessment the participants will perform an inertial gait analysis, a static posturography, and will undergo functional capacity assessments (TUG, 2MWT, 5-STST, 10- mFW).
详细描述
Parkinson's Disease (PD) is a chronic and progressive neurodegenerative condition, clinically characterized by the presence of bradykinesia, resting tremor, rigidity, and postural instability. Individuals affected by this condition exhibit several gait abnormalities, characterized by reduced speed, short and shuffling steps, and increased step variability.
In recent decades, efforts have been made towards the development of sustainable and implementable strategies in the daily lives of these individuals, aimed at improving posture and gait performances.
In this context, the role of enhanced plantar biofeedback is under investigation. For example, plantar sensory stimulation seems to improve postural adjustments and gait. Moreover, it has been observed that the barefoot contact of the foot with the ground, as opposed to wearing a shoe, is capable of providing greater feedback, thus improving posture and locomotion. Improved locomotion leads to increased safety while performing daily living activities, a reduction in the risk of falls, and therefore an increase in quality of life. Studies in the literature are primarily focused on stimulating insoles and footwear with integration of vibratory, auditory, and/or visual biofeedback.
The applicability of electronic footwear is currently limited. A possible sustainable solution could be the use of footwear that minimizes the separation of the foot from the external environment, while effectively protecting it from possible injuries. This type of footwear conforms to the shape of the foot, potentially allowing for greater plantar feedback when compared to traditional shoes. Gait using inertial sensors represents an easily implementable method in research and clinical practice, with application in numerous neurological syndromes. A device worn at the lumbar level can measure spatiotemporal parameters of gait. Moreover, it is possible to calculate trunk-derived accelerometric indexes. In particular, the Harmonic Ratio (HR) is a representative index of the fluidity and rhythm of physiological gait. It is therefore a reliable parameter for evaluating possible gait alterations in neurological patients.
The primary aim of the study is to verify whether the use of footwear providing increased plantar feedback improves HR in PD patients.
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)
入排标准
- 年龄范围
- 40 Years 至 80 Years（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 clinical diagnostic criteria of the Movement Disorders Society (Postuma RB, 2015);
- •Hoehn & Yahr between II and IV;
- •Stable medical therapy since at least one month before enrollment
排除标准
- •Concomitant diagnosis of other neurological or psychiatric disorders that may influence study assessments.;
- •MMSE score <24;
- •Patients with DBS implant or on DuoDopa therapy;
- •Presence of relevant musculoskeletal or orthopedic pathologies;
- •Presence of relevant internal or vascular pathologies.
结局指标
主要结局
Harmonic Ratio (HR)
时间窗: After intervention, an average of 2 year (T1)
Comparison of HR (continuous variable without unit of measurement) between feedback shoes patients, Neutral Shoes patients and the Barefoot control condition.
次要结局
- Comparison of coefficient of variation between feedback shoes patients and Neutral Shoes patients.(Double evaluation at baseline (T0) and four weeks after intervention (T1),an average of 2 year.)
- Comparison of normalized jerk score between Finger Shoes patients and Neutral Shoes patients.(Double evaluation at baseline (T0) and four weeks after intervention (T1), an average of 2 year.)
- Comparison of coefficient of variation in patients between Finger Shoes patients and Neutral Shoes patients.(Double evaluation at baseline (T0) and four weeks after intervention (T1), an average of 2 year.)
- Comparison of Harmonic Ratio in patients between Finger Shoes patients and Neutral Shoes patients.(Double evaluation at baseline (T0) and four weeks after intervention (T1), an average of 2 year.)
- Comparison of recurrence quantification analysis between feedback shoes patients and Neutral Shoes patients.(Double evaluation at baseline (T0) and four weeks after intervention (T1), an average of 2 year.)
- Posturographic evaluation(Double evaluation at baseline (T0) and four weeks after intervention (T1), an average of 2 year)
- Comparison of Multiscale entropy between Finger Shoes patients and Neutral Shoes patients.(Double evaluation at baseline (T0) and four weeks after intervention (T1), an average of 2 year.)
- Timed-Up and Go (TUG) test(Double evaluation at baseline (T0) and four weeks after intervention (T1), an average of 2 year)
- 5 sit to stand test (5-STST)(Double evaluation at baseline (T0) and four weeks after intervention (T1), an average of 2 year.)
- 2-minute walk test (2MWT)(Double evaluation at baseline (T0) and four weeks after intervention (T1), an average of 2 year.)
- 10-m free walk (10-mFW) test(Double evaluation at baseline (T0) and four weeks after intervention (T1), an average of 2 year.)