Progressive Modular Rebalancing (RMP) System Rehabilitation Combined With Sensory Cues for Rehabilitation of Patients With PD: a Randomized, Controlled Trial With Crossover.

University of Roma La Sapienza2 个研究点分布在 1 个国家目标入组 47 人开始时间: 2015年5月1日最近更新: 2017年11月21日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 47
试验地点: 2
主要终点: swing phase duration ( change )

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

In the present study, the investigators propose a rehabilitative program for Parkinson' disease based on the combination of a neurocognitive method, i.e. visual sensory cues, with a neurophysiological method, i.e. RMP, in a randomized controlled trial with cross-over. The rationale herein was that the RMP may globally improve patients in terms of trunk control, motor performance, muscle tone, endurance and so on, predisposing them to improvement of the gait rhythm and automaticity induced by use of the visual external cues.

The primary aim of this pilot, randomized, controlled, trial with crossover was to establish whether a 8-week exercise program focused at improving gait in people with PD was more effective than a same-duration program of standard physiotherapy. The secondary aim was to evaluate the effect on the disease's severity. At this aims investigators used a quantitative 3D motion analysis system to evaluate gait parameters and UPDRS-II and UPDR-III and H-Y staging to evaluate the severity of the disease.

The investigators hypothesised that the both exercise programs will improve standard physiotherapy, however the proposed program will yield better improvements for the people with PD.

详细描述

This study is a pilot, bi-centric, exploratory, randomized, controlled, crossover design with blind observer .

Subjects participated in a baseline assessment session (T0, before rehabilitative treatment), followed by random allocation to 8 weeks of rehabilitative treatments (A or B) (T1), followed by 1 month of inactivity wash out period. Following this wash-out period, patients who received treatment A switched to the treatment B and viceversa. A computerized randomization schedule was generated on the computer and held by an investigator not involved in subject recruitment or assessment.

Both clinical (neurological visit and scale administration) and instrumental (gait analysis) assessments were carried out 3 times: at baseline before rehabilitative treatment (T0), 4 weeks (T1, intermediate evaluation) and 8 weeks after rehabilitative treatments (T2, final evaluation). Medication was kept constant throughout the trial, and all interventions were performed at the same time of day for each patient during ON phase.

Participants were asked to maintain their pre-enrollment activity level and current medication dosage when not in the laboratory.

Assessors, for both clinical and instrumental evaluations, were blinded to the allocation treatment.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围: 55 Years 至 76 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•diagnosis of idiopathic PD according to UK bank criteria
•Hoehn and Yahr stages 1 to
•United Parkinson Disease Rating Scale (UPDRS) gait subscore of 1 or more, no change in medication during the study period.
•All patients were in a stable drug program and had adapted to their current medications for at least 2 weeks.

排除标准

•cognitive deficits (defined as scores of <26 on the Mini-Mental State Examination [MMSE]),
•moderate or severe depression (defined as scores of >17 on the Beck Depression Inventory [BDI]),
•orthopedic and other gait-influencing diseases such as arthrosis or total hip joint replacement.

研究组 & 干预措施

Group A

Experimental

Treatment A consisted in a combined exercise program of 40 min duration RMP (Monari, 2004; Monari et al., 2016) and 20 min duration of gait training with sensory cues.

RMP. RMP protocol was based on lengthening and muscular recruitment exercises by means of complex motor skills involving muscular kinetic chains in lower limbs and trunk. Each session was divided into muscular stretching exercise, aiming to increase step length and rotating trunk movements, and tailored progressive exercise therapy.

干预措施: Treatment A combined exercise program and gait training with sensory cues (Other)

Group B

Experimental

Treatment B Conventional physiotherapy was composed of 4 sections of exercises, chiefly oriented to different body structures appropriate to movement (International Classification of Functioning, Disability and Health code): trunk (s760), pelvis (s750), lower extremity (s750), and upper extremity (s730) including shoulder region (s720). Domains focused on were (1) warm-up exercises, (2) trunk mobility exercises, (3) postural stability (b715), and (4) transferring oneself (d420) and changing body positions (d410).

干预措施: Treatment B Conventional physiotherapy (Other)