---
title: Assessment of the Psychophysical State During Rehabilitation Treatment With Lokomat
nct_id: NCT05767268
overall_status: COMPLETED
sponsor: IRCCS Eugenio Medea
study_type: OBSERVATIONAL
primary_condition: Cerebral Palsy
countries: Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05767268.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05767268"
ct_last_update_post_date: 2024-03-13
last_seen_at: "2026-05-12T06:51:17.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Assessment of the Psychophysical State During Rehabilitation Treatment With Lokomat

**NCT ID:** [NCT05767268](https://clinicaltrials.gov/study/NCT05767268)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 48
- **Lead Sponsor:** IRCCS Eugenio Medea
- **Conditions:** Cerebral Palsy, Acquired Brain Injury, Hereditary Spastic Paraplegia
- **Start Date:** 2022-02-02
- **Completion Date:** 2023-12-31
- **CT.gov Last Update:** 2024-03-13

## 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

- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **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.

## Interventions

- **Lokomat** (DEVICE) — gait rehabilitation

## Primary Outcomes

- **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.
- **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 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.
- **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

- **Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 2** _(time frame: three days)_
- **Ad Hoc questionnaire for therapist evaluation of the patient emotional state session 2** _(time frame: three days)_
- **Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 2** _(time frame: three days)_
- **Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 8** _(time frame: two weeks)_
- **Ad Hoc questionnaire for therapist evaluation of the patient emotional state session 8** _(time frame: two weeks)_
- **Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 8** _(time frame: two weeks)_
- **Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 14** _(time frame: three weeks)_
- **Ad Hoc questionnaire for therapist evaluation of the patient emotional state session 14** _(time frame: three weeks)_
- **Ad Hoc questionnaire for patient self evaluation of his/her emotional state session 14** _(time frame: three weeks)_

## Locations (1)

- IRCCS Medea, Bosisio Parini, Italy

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.irccs medea|bosisio parini||italy` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT05767268*  
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