Clinical trial NCT05767268: Assessment of the Psychophysical State During Rehabilitation Treatment With Lokomat
Official title: Assessment of the Psychophysical State During Rehabilitation Treatment With Lokomat
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Acquired Brain Injury
Hereditary Spastic Paraplegia
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients that need gait rehabilitation treatment according to their clinician

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.


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.

Primary outcomes:
measure: Heart Rate Variability (HRV) session 2
timeFrame: three days
measure: Electrodermal activity (EDA) session 2
timeFrame: three days
measure: Heart Rate Variability (HRV) session 8
timeFrame: two weeks
measure: Electrodermal activity (EDA) session 8
timeFrame: two weeks
measure: Heart Rate Variability (HRV) session 14
timeFrame: three weeks
measure: Electrodermal activity (EDA) session 14
timeFrame: three weeks
Secondary outcomes:
measure: Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 2
timeFrame: three days
measure: Ad Hoc questionnaire for therapist evaluation of the patient emotional state session 2
timeFrame: three days
measure: Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 2
timeFrame: three days
measure: Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 8
timeFrame: two weeks
measure: Ad Hoc questionnaire for therapist evaluation of the patient emotional state session 8
timeFrame: two weeks
measure: Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 8
timeFrame: two weeks
measure: Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 14
timeFrame: three weeks
measure: Ad Hoc questionnaire for therapist evaluation of the patient emotional state session 14
timeFrame: three weeks
measure: Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 14
timeFrame: three weeks
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS Medea
Study officials:
References: