Study of Motor Recovery and Biomechanical Adaptation Mechanisms in Amputee Patients Using an Immersive Virtual Reality System (CAREN)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Kinematic data
研究概览
简要总结
Interventional, non-pharmacological crossover study aimed at identify statistically significant differences in postural stability and spatio-temporal gait cycle parameters in patients with lower limb amputation by means of taskoriented rehabilitation training and multisensory feedback generated by an immersive RV environment, aiming at the enhancement of use-dependent brain plasticity. These changes will be compared between the two groups examined, respectively experimental (Caren virtual training phase plus conventional physiotherapy phase) and control (conventional physiotherapy phase plus Caren virtual training phase).
详细描述
Primary objectives: Evaluation of biomechanical and spatio-temporal asymmetries in gait in subjects with lower limb amputation by motion capture systems; improvement of postural stability and gait cycle in patients with lower limb amputation by "task-oriented" rehabilitation training and multisensory feedback generated by an immersive virtual reality environment, aiming at the enhancement of use-dependent brain plasticity; improving body weight distribution on both lower limbs, during static and dynamic activities, through more effective control of the body's centre of gravity. Secondary objectives include improving mood, psycho-social wellbeing and quality of life in lower limb amputees.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •unilateral lower limb amputation
- •ability to walk independently
- •age between 18 and 75 years
- •absence of severe comorbidities that may interfere with treatment
排除标准
- •presence of severe neurological and psychiatric disorders
- •walking with aids
研究组 & 干预措施
Virtual environment practiced on the Caren
Caren virtual training phase plus conventional physiotherapy phase
干预措施: Virtual environment practiced on the Caren (Behavioral)
Conventional physiotherapy
Conventional physiotherapy phase plus Caren virtual training phase
干预措施: Conventional physiotherapy (Behavioral)
结局指标
主要结局
Kinematic data
时间窗: seven months
From the gait analysis, the investigators will obtain kinematic data, including spatial and temporal parameters measured during standing acquisition and kinematic analysis evaluated from the walking trials recordings.
Kinetic data
时间窗: seven months
From the gait analysis, the investigators will obtain kinetic data concerning the joint moments and powers, joints moments and powers normalized by the subject's weight (Newton\*meter/kg e Watt/kg) and ground reaction forces reported in percentage to the body weight will be averaged across all cycles for each subject for each evaluating session.
Electromyography
时间窗: seven months
From the gait analysis, the investigators will obtain electromyographic data on electromyopgraphic signals, regarding muscle contraction, which will be recorded with surface electrodes. The raw signals (millivolts) will be filtered with a band pass filter (20 - 450 Hz) and time-normalized for the duration of the gait cycle (% gait cycle).
次要结局
未报告次要终点
研究者
Mirjam Bonanno
Principal Investigator
IRCCS Centro Neurolesi "Bonino-Pulejo"