Innovative Models in the Rehabilitation of the Elderly With Parkinson's Disease Through Technological Innovation

Официальное название

Assistive Robotic in the Elderly: Innovative Models in the Rehabilitation of the Elderly With Parkinson's Disease Through Technological Innovation

Обзор

The final goal of the present study is to propose a new approach in the Parkinson's Disease rehabilitation, focused on the use of robotic devices and to check the results not only at the end of the treatment but also in the long term, foreseeing 3 follow-up.

Подробное описание

Parkinson's disease is one of the most frequent causes of disability among the elderly. It is a chronic-progressive neuro-degenerative disease, characterized by several motor disorders. The balance disorder is a symptom that involves the body axis; it is due to a reduction in the straightening reflexes, so the subject is not able to correct any imbalances. Balance disorders do not respond to dopaminergic therapy used in Parkinson's disease. Therefore, physiotherapy becomes an important intervention for the management of motor disorders. Originally, these rehabilitative approaches were based on empirical experiences, but several scientific evidence suggests that neuronal plasticity is exercise-dependent. In this context, robotic rehabilitation performs an important role because it allows to perform task-oriented exercises and to increase the number of repetitions and their intensity. This protocol study aims to evaluate an innovative rehabilitation treatment of the elderly patients with Parkinson's disease, designed to improve the gait and to reduce the risk of falling. The treatment involves the use of two robotic devices: Tymo system and Walker View.

This study is a single-blinded randomized controlled trial. 195 patients with PD will be recruited and randomly divided into three groups, to receive a traditional rehabilitation program or a robotic rehabilitation using Tyro system or Walker View in addition to the traditional therapy. Assessments will be performed at baseline, at the end of treatment and 6 months, 1 year and 2 years from the end of the treatment. A 10 treatment sessions will be conducted, divided into 2 training sessions per week, for 5 weeks. The control group will perform traditional therapy sessions lasting 50 minutes. The technological intervention group will carry out 30 minutes of traditional therapy and 20 minutes of treatment with a robotic system.

Вмешательства

• Другое control arm
  Each session will include 50 minutes of traditional physical rehabilitation therapy
• Другое virtual reality games
  Each session will include 30 minutes of traditional physical rehabilitation therapy followed by 20 minutes of robotic Tymo system (Tyromotion, Austria), a wireless static and dynamic platform, for evaluating and rehabilitating posture.
• Другое robotic treadmill
  Each session will include 30 minutes of traditional physical rehabilitation therapy followed by 20 minutes of robotic Walker View (TecnoBody, Italy) a treadmill equipped with a sensorized belt with eight load cells and a 3D camera

Первичные конечные точки

• difference in falling risk among virtual reality games arm, robotic treadmill arm and control arm [Срок оценки: before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment]

Вторичные конечные точки (2)

• difference in gait performance among virtual reality games arm, robotic treadmill arm and control arm [Срок оценки: before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment]
• difference in fear of falling among virtual reality games arm, robotic treadmill arm and control arm [Срок оценки: before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment]

Критерии участия

Критерии включения

• Hoen and Yahr scale: 1-3 stage
• FAC ≤ 2
• Ranking scale score ≤ 3
• Stability of drug treatment for at least 1 month
• Geriatric Depression Scale 5-items: negative

Критерии исключения

• Concomitant participation in other studies
• Lack of written informed consent
• Clinical dementia rating (CDR) score ≥ 3
• History of syncopal episodes, epilepsy and vertigo not controlled pharmacologically
• Serious dysfunction of the autonomic system
• Severe behavioral syndromes not compensated by drugs
• Concurrent neurological diseases
• Severe systemic diseases with life expectancy < 1 year
• Patients unable to follow up.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Италия · 2 центра

• IRCCS INRCA Hospital — Ancona
• IRCCS INRCA Hospital — Fermo

Публикации

• Maranesi E, Casoni E, Baldoni R, Barboni I, Rinaldi N, Tramontana B, Amabili G, Benadduci M, Barbarossa F, Luzi R, Di Donna V, Scendoni P, Pelliccioni G, Lattanzio F, Riccardi GR, Bevilacqua R. The Effect of Non-Immersive Virtual Reality Exergames versus Traditional Physiotherapy in Parkinson's Disease Older Patients: Preliminary Results from a Randomized-Controlled Trial. Int J Environ Res Public PMID 36429537
• Bevilacqua R, Maranesi E, Di Rosa M, Luzi R, Casoni E, Rinaldi N, Baldoni R, Lattanzio F, Di Donna V, Pelliccioni G, Riccardi GR. Rehabilitation of older people with Parkinson's disease: an innovative protocol for RCT study to evaluate the potential of robotic-based technologies. BMC Neurol. 2020 May 13;20(1):186. doi: 10.1186/s12883-020-01759-4. PMID 32404132

Идентификаторы

NCT: NCT04087031 · INRCA_02_2019

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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