跳至主要内容
临床试验/NCT05802498
NCT05802498已完成不适用

IR3MA Parkinson Cyclone in Life: Innovation, R3 Rehabilitation - Resonance - RTD Fluxgate Sensor, Multidisciplinary Approach

IRCCS Centro Neurolesi "Bonino-Pulejo"1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年7月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Berg Balance Scale (BBS)

研究概览

简要总结

Comparison of two rehabilitation protocols in patients with Parkinson's disease and, therefore, identification of innovative rehabilitation protocols of proven and validated efficacy, through which it is possible to achieve:

  • Improved joint function and gait pattern
  • Reduction of the risk of falling or reduction of energy expenditure during physiological gait

Evaluation of the increase in maximal effort tolerance

· Improved cognitive performances

Evaluation of the impact on the quality of life of the patient and family members

Identification of morpho-functional markers predictive of clinical and rehabilitative out-come through neuroimaging study.

详细描述

rehabilitation protocols in patients with Parkinson's disease and, therefore, identification of innovative rehabilitation protocols of proven and validated efficacy, through which it is possible to achieve:

Improved joint function and gait pattern Reduction of the risk of falling or reduction of energy expenditure during physiological gait Evaluation of the increase in maximal effort tolerance

· Improved cognitive performances

Evaluation of the impact on the quality of life of the patient and family members

Identification of morpho-functional markers predictive of clinical and rehabilitative out-come through neuroimaging study.

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
None

入排标准

年龄范围
60 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Hoehn & Yahr between 2.0 and 3.0;
  • •No need for a walking aid;
  • •Mini-Mental State Examination (MMSE) score >24;
  • •Effective dopaminergic pharmacological control;
  • •Absence of other relevant neurological comorbidities;
  • •Absence of postural deformities (and/or Pisa syndrome);
  • •Absence of severe cardiological pathologies (exertional angina, severe decompensation).
  • •Ability to travel to the rehabilitation treatment site independently or with support

排除标准

  • •presence of Deep Brain Stimulation (DBS);
  • •presence of severe heart and/or lung disease;
  • •presence of therapeutic regimen in the definition phase;
  • •impaired joint and/or motor function to follow a proposed rehabilitation treatment programme
  • •contraindications to performing MRI scans
  • •undergoing rehabilitation therapy in the 3 months preceding enrolment.

研究组 & 干预措施

control GROUP

No Intervention

This group will perform 8 continuous weeks of treatment, 5 days a week, for a total of 180 minutes, including muscle stretching, joint range increase with passive and active assisted mobilization sessions of the scapulohumeral and pelvic girdles. Motor coordination exercises. Postural exercises with exercises for trunk control in sitting and standing positions with feedback and feed-forward techniques. gait training; gait training; proprioceptive exercises and exercises to maintain static and dynamic balance in monopodalica; strengthening of trunk muscles; postural exercises, muscle relaxation/stretching, release of the tracks; re-education in postural passages and transfers with fall prevention strategies.

irma group

Experimental

This group will perform 8 continuous weeks of treatment, 5 days a week, for a total of 180 minutes, including muscle stretching, increasing joint range with assisted passive and active mobilisation sessions of the scapulohumeral and pelvic girdles. Motor coordination exercises. Postural exercises with exercises for trunk control in sitting and standing with feedback and feed-forward technique. Gait training; gait training; proprioceptive exercises and static and dynamic balance maintenance in monopodalics; trunk muscle strengthening; postural exercises, muscle relaxation/relaxation, caterpillar release; re-education in postural transitions and transfers with fall prevention strategies. Prior to neuromotor rehabilitation treatment, the subjects will undergo rehabilitation training using the NIRVANA augmentative reality system.

干预措施: IRMA (Device)

结局指标

主要结局

Berg Balance Scale (BBS)

时间窗: 8 weeks

The Berg Balance Scale is a scale for assessing balance and the risk of falling

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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