跳至主要内容
临床试验/NCT05767268
NCT05767268已完成不适用

Assessment of the Psychophysical State During Rehabilitation Treatment With Lokomat

IRCCS Eugenio Medea1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年2月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
1
主要终点
Electrodermal activity (EDA) session 14

研究概览

简要总结

The use of robotic technologies in rehabilitation is an increasingly widespread practice in the health sector: the Lokomat is a medical device intended for walking rehabilitation, consisting of an exoskeleton, a treadmill and a harness that supports the body weight and acts as a safety tool This technology is useful in the rehabilitation of pathologies such as prenatal stroke, brain injury, paraplegia, multiple sclerosis and other motor, orthopedic and neurological problems. During these treatments, the psychological / emotional component of the patient is not properly considered and the success of the treatment remains focused on the motor-rehabilitation level.

The management of subjective-experiential aspects remains in the hand of clinical figures (primarily physiotherapists) who have no tools for objective assessment other than their sensitivity. However, considering the experience is fundamental for the success of the therapy: this happens especially in the pediatric field, where clinical results improve significantly when children start therapy with a relaxed and positive mental state.

The aim of this project is to investigate the rehabilitation experience of patients who perform gait rehabilitation by menas of the Lokomat system, considering the relationship between physiological parameters and moods. Therefore, the main goal is to monitor the patient's psychophysical condition before, during and after the rehabilitation activity, during the different sessions. This will allow describing, with qualitative and quantitative data, the user experience of the patient who undergoes a therapeutic treatment with the Lokomat.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • patients that need gait rehabilitation treatment according to their clinician

排除标准

  • subjects unable to understand and execute simple instructions;
  • subjects with skin problems in the wrist area intended for the application of the Empatica bracelet.

结局指标

主要结局

Electrodermal activity (EDA) session 14

时间窗: three weeks

EDA is meadured during the 14th session of Lokomat rehabilitation by means of the electrodermal activity sensor of Empatica E4 bracelet.

Electrodermal activity (EDA) session 8

时间窗: two weeks

EDA is meadured during the 8th session of Lokomat rehabilitation by means of the electrodermal activity sensor of Empatica E4 bracelet.

Heart Rate Variability (HRV) session 2

时间窗: three days

HRV is measured during the second session of Lokomat rehabilitation by means of the photoplethysmogram sensor (PPG) of Empatica E4 bracelet.

Electrodermal activity (EDA) session 2

时间窗: three days

EDA is meadured during the second session of Lokomat rehabilitation by means of the electrodermal activity sensor of Empatica E4 bracelet.

Heart Rate Variability (HRV) session 8

时间窗: two weeks

HRV is measured during the eighth session of Lokomat rehabilitation by means of the photoplethysmogram sensor (PPG) of Empatica E4 bracelet.

Heart Rate Variability (HRV) session 14

时间窗: three weeks

HRV is measured during the 14th session of Lokomat rehabilitation by means of the photoplethysmogram sensor (PPG) of Empatica E4 bracelet.

次要结局

  • Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 2(three days)
  • Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 14(three weeks)
  • Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 8(two weeks)
  • Ad Hoc questionnaire for therapist evaluation of the patient emotional state session 2(three days)
  • Ad Hoc questionnaire for therapist evaluation of the patient emotional state session 14(three weeks)
  • Ad Hoc questionnaire for therapist evaluation of the patient emotional state session 8(two weeks)

研究者

发起方
IRCCS Eugenio Medea
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验