Skip to main content
Clinical Trials/NCT05767268
NCT05767268
Completed
Not Applicable

Assessment of the Psychophysical State During Rehabilitation Treatment With Lokomat

IRCCS Eugenio Medea1 site in 1 country48 target enrollmentFebruary 2, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
IRCCS Eugenio Medea
Enrollment
48
Locations
1
Primary Endpoint
Electrodermal activity (EDA) session 14
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 2, 2022
End Date
December 31, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
IRCCS Eugenio Medea
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patients that need gait rehabilitation treatment according to their clinician

Exclusion Criteria

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

Outcomes

Primary Outcomes

Electrodermal activity (EDA) session 14

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: three weeks

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

Secondary Outcomes

  • 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)

Study Sites (1)

Loading locations...

Similar Trials