Assessment of the Psychophysical State During Rehabilitation Treatment With Lokomat

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Acquired Brain Injury; Hereditary Spastic Paraplegia
• Intervention / Treatment: Device: Lokomat

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• Italy
  • Bosisio Parini, Italy
    • IRCCS Medea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients that need gait rehabilitation treatment according to their clinician

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

treated with Lokomat; Patients perform a rehabilitation treatment of 15 or 20 sessions with lokomat + 15 or 20 sessions of physiotherapy in 3 or 4 weeks as defined by the clinician. During two or three sessions they wear a wearable device Empatica E4 that measure their electrocardiographic (ECG) activity and electrodermal activity (EDA). They also have a baseline acquisition of these signals in their room at hospital.

Device: Lokomat; gait rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: IRCCS Eugenio Medea

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Congenital Abnormalities; Brain Damage, Chronic; Genetic Diseases, Inborn; Neuromuscular Diseases; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Heredodegenerative Disorders, Nervous System; Nervous System Malformations; Paralysis; Polyneuropathies; Hereditary Sensory and Motor Neuropathy; Cerebral Palsy; Brain Injuries; Paraplegia; Spastic Paraplegia, Hereditary
• Other Study ID Numbers: GIP919

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No