Cerebral PalsyNCT05767268
Assessment of the Psychophysical State During Rehabilitation Treatment With Lokomat
An observational study of Cerebral Palsy and Acquired Brain Injury, run by IRCCS Eugenio Medea at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebral Palsy, Acquired Brain Injury, Hereditary Spastic Paraplegia
- What is being tested?
- Lokomat
- Type of treatment
- Medical device
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 2 Feb 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients that need gait rehabilitation treatment according to their clinician
Who may be able to join
- patients that need gait rehabilitation treatment according to their clinician
Who cannot join
- subjects unable to understand and execute simple instructions;
- subjects with skin problems in the wrist area intended for the application of the Empatica bracelet.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Lokomat
- Medical subject headings
- Cerebral Palsy, Brain Injuries, Spastic Paraplegia, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LokomatDevice
gait rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Lokomat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: three weeks
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start2 Feb 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767268
- Sponsor's protocol ID
- GIP919
- Status last verified
- Mar 2024
- First submitted
- 27 Oct 2022
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chiappini M, Malerba G, Dei C, Bellazzecca S, Falivene A, Costantini S, Morganti R, Diella E, Storm F, Ambrosini E, Cavallo A, Biffi E. Understanding patient experience during Lokomat rehabilitation in children and adolescents: a clinical observational study combining self-evaluation and physiological metrics. BMJ Open. 2026 Feb 10;16(2):e102583. doi: 10.1136/bmjopen-2025-102583.
PubMed 41667181
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Psychophysical State During Rehabilitation Treatment With Lokomat
- ClinicalTrials.gov ID
- NCT05767268
- Acronym / sponsor ID
- GIP919
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 14 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treated with Lokomat | – | Device: LokomatPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients that need gait rehabilitation treatment according to their clinician
Key inclusion criteria (1 listed)
- patients that need gait rehabilitation treatment according to their clinician
Key exclusion criteria (2 listed)
- subjects unable to understand and execute simple instructions;
- subjects with skin problems in the wrist area intended for the application of the Empatica bracelet.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lokomatgait rehabilitation | Device | treated with Lokomat |
Primary outcome
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.
9 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Derived from this study: PubMed 41667181Chiappini M, Malerba G, Dei C, Bellazzecca S, Falivene A, Costantini S, Morganti R, Diella E, Storm F, Ambrosini E, Cavallo A, Biffi E. Understanding patient experience during Lokomat rehabilitation in children and adolescents: a clinical observational study combining self-evaluation and physiological metrics. BMJ Open. 2026 Feb 10;16(2):e102583. doi: 10.1136/bmjopen-2025-102583.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Acquired Brain Injury, run by IRCCS Eugenio Medea at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (HRV) session 2 (time frame: three days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05767268, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.