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NCT Number: NCT05767268

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.

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Key information

Conditions

Cerebral Palsy Acquired Brain Injury Brain Damage, Chronic Brain Diseases Brain Injuries Central Nervous System Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniocerebral Trauma Genetic Diseases, Inborn Hereditary Sensory and Motor Neuropathy Hereditary Spastic Paraplegia Heredodegenerative Disorders, Nervous System Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Polyneuropathies Spastic Paraplegia, Hereditary Trauma, Nervous System Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Medea

Bosisio Parini, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lokomat

Device

gait rehabilitation

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 2

    Time frame: three days

    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.

  2. Ad Hoc questionnaire for therapist evaluation of the patient emotional state session 2

    Time frame: three days

    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.

  3. Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 2

    Time frame: three days

    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.

  4. Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 8

    Time frame: two weeks

    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.

  5. Ad Hoc questionnaire for therapist evaluation of the patient emotional state session 8

    Time frame: two weeks

    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.

  6. Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 8

    Time frame: two weeks

    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.

  7. Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 14

    Time frame: three weeks

    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.

  8. Ad Hoc questionnaire for therapist evaluation of the patient emotional state session 14

    Time frame: three weeks

    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.

  9. Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 14

    Time frame: three weeks

    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.

Sponsors and collaborators

Lead sponsor

IRCCS Eugenio Medea

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 14, 2023
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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