Assessment of the Psychophysical State During Rehabilitation Treatment With Lokomat

Cerebral Palsy Clinical Trial

Official title:

Assessment of the Psychophysical State During Rehabilitation Treatment With Lokomat

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05767268
• Other study ID #: GIP919
• Status: Completed
• Start date: February 2, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: IRCCS Eugenio Medea
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Cerebral Palsy
• Hereditary Spastic Paraplegia
• Paraplegia
• Spastic Paraplegia, Hereditary

Intervention

Device:
• Lokomat
gait rehabilitation

Locations

Country	Name	City	State
Italy	IRCCS Medea	Bosisio Parini

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Eugenio Medea

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate Variability (HRV) session 2	HRV is measured during the second session of Lokomat rehabilitation by means of the photoplethysmogram sensor (PPG) of Empatica E4 bracelet.	three days
Primary	Electrodermal activity (EDA) session 2	EDA is meadured during the second session of Lokomat rehabilitation by means of the electrodermal activity sensor of Empatica E4 bracelet.	three days
Primary	Heart Rate Variability (HRV) session 8	HRV is measured during the eighth session of Lokomat rehabilitation by means of the photoplethysmogram sensor (PPG) of Empatica E4 bracelet.	two weeks
Primary	Electrodermal activity (EDA) session 8	EDA is meadured during the 8th session of Lokomat rehabilitation by means of the electrodermal activity sensor of Empatica E4 bracelet.	two weeks
Primary	Heart Rate Variability (HRV) session 14	HRV is measured during the 14th session of Lokomat rehabilitation by means of the photoplethysmogram sensor (PPG) of Empatica E4 bracelet.	three weeks
Primary	Electrodermal activity (EDA) session 14	EDA is meadured during the 14th session of Lokomat rehabilitation by means of the electrodermal activity sensor of Empatica E4 bracelet.	three weeks
Secondary	Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 2	VAS questionnaire is proposed to the subjects before the second session of Lokomat rehabilitation in order to collect patients' self-evaluation about their emotional state before and after the treatment.; The following questions were proposed: Q1. "Are you worried?" Q2. "Are you happy" Q3. "Are you sad?" Q4. "Are you angry?" Q5. "Are you scared?" Q6. "Are you bored?" Possible answers were: not at all, a little, very much.	three days
Secondary	Ad Hoc questionnaire for therapist evaluation of the patient emotional state session 2	During the second session of Lokomat rehabilitation, the physiotherapist was asked to fill in an ad hoc questionnaire to collect a reliable evaluation of different levels of anxiety, activity, persistence of the patient. In particular, items of the proposed therapists' evaluation are reported below: The patient is passive/ proactive The patient is fearful/in control of the situation The patient is anxious/relaxed The patient is impulsive /thoughtful The patient is distracted /focused The patient is hyperactive/quiet The patient underestimates/overestimates his/her abilities The patient is not/ is persistent The patient is concerned/does not care about failure The patient is unable/able to derive satisfaction from success The patient manages emotions in a negative/positive manner The patient does not/does actively seek information to learn and update The therapist gives an evaluation to each item with a numerical score ranging from -3 to 3.	three days
Secondary	Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 2	VAS questionnaire is proposed to the subjects after the 8th session of Lokomat rehabilitation in order to collect patients' self-evaluation about their emotional state before and after the treatment.; The following questions were proposed: Q1. "Are you worried?" Q2. "Are you happy" Q3. "Are you sad?" Q4. "Are you angry?" Q5. "Are you scared?" Q6. "Are you bored?" Possible answers were: not at all, a little, very much.	three days
Secondary	Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 8	VAS questionnaire is proposed to the subjects before the 8th session of Lokomat rehabilitation in order to collect patients' self-evaluation about their emotional state before and after the treatment.; The following questions were proposed: Q1. "Are you worried?" Q2. "Are you happy" Q3. "Are you sad?" Q4. "Are you angry?" Q5. "Are you scared?" Q6. "Are you bored?" Possible answers were: not at all, a little, very much.	two weeks
Secondary	Ad Hoc questionnaire for therapist evaluation of the patient emotional state session 8	During the 8th session of Lokomat rehabilitation, the physiotherapist was asked to fill in an ad hoc questionnaire to collect a reliable evaluation of different levels of anxiety, activity, persistence of the patient. In particular, items of the proposed therapists' evaluation are reported below: The patient is passive/ proactive The patient is fearful/in control of the situation The patient is anxious/relaxed The patient is impulsive /thoughtful The patient is distracted /focused The patient is hyperactive/quiet The patient underestimates/overestimates his/her abilities The patient is not/ is persistent The patient is concerned/does not care about failure The patient is unable/able to derive satisfaction from success The patient manages emotions in a negative/positive manner The patient does not/does actively seek information to learn and update The therapist gives an evaluation to each item with a numerical score ranging from -3 to 3.	two weeks
Secondary	Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 8	VAS questionnaire is proposed to the subjects after the second session of Lokomat rehabilitation in order to collect patients' self-evaluation about their emotional state before and after the treatment.; The following questions were proposed: Q1. "Are you worried?" Q2. "Are you happy" Q3. "Are you sad?" Q4. "Are you angry?" Q5. "Are you scared?" Q6. "Are you bored?" Possible answers were: not at all, a little, very much.	two weeks
Secondary	Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 14	VAS questionnaire is proposed to the subjects before the 14th session of Lokomat rehabilitation in order to collect patients' self-evaluation about their emotional state before and after the treatment.; The following questions were proposed: Q1. "Are you worried?" Q2. "Are you happy" Q3. "Are you sad?" Q4. "Are you angry?" Q5. "Are you scared?" Q6. "Are you bored?" Possible answers were: not at all, a little, very much.	three weeks
Secondary	Ad Hoc questionnaire for therapist evaluation of the patient emotional state session 14	During the 14th session of Lokomat rehabilitation, the physiotherapist was asked to fill in an ad hoc questionnaire to collect a reliable evaluation of different levels of anxiety, activity, persistence of the patient. In particular, items of the proposed therapists' evaluation are reported below: The patient is passive/ proactive The patient is fearful/in control of the situation The patient is anxious/relaxed The patient is impulsive /thoughtful The patient is distracted /focused The patient is hyperactive/quiet The patient underestimates/overestimates his/her abilities The patient is not/ is persistent The patient is concerned/does not care about failure The patient is unable/able to derive satisfaction from success The patient manages emotions in a negative/positive manner The patient does not/does actively seek information to learn and update The therapist gives an evaluation to each item with a numerical score ranging from -3 to 3.	three weeks
Secondary	Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 14	VAS questionnaire is proposed to the subjects after the 14th session of Lokomat rehabilitation in order to collect patients' self-evaluation about their emotional state before and after the treatment.; The following questions were proposed: Q1. "Are you worried?" Q2. "Are you happy" Q3. "Are you sad?" Q4. "Are you angry?" Q5. "Are you scared?" Q6. "Are you bored?" Possible answers were: not at all, a little, very much.	three weeks