Cerebral Palsy InfantileAID2GAITNCT06947889
Biofeedback Based System to Enhance Robotic Assisted Gait Training in Children With Cerebral Palsy
An observational study of Cerebral Palsy Infantile and Robotic Assisted Gait Training, run by G. d'Annunzio University at 1 site in Italy.
Trial summary
The AID2GAIT project aims to develop a biofeedback system with the aim of improving the outcomes of robot-assisted gait training (RAGT) in pediatric patients with cerebral palsy. The physiological signals of children during RAGT therapy sessions, acquired through non-invasive technologies, will be analyzed. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Cerebral Palsy Infantile, Robotic Assisted Gait Training
- What is being tested?
- RAGT
- How many people
- 11 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2024to 28 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with cerebral palsy aged 3 to 18 years who have a GMFCS level from I to V, with the ability to express discomfort or pain and understanding simple instructions
Who may be able to join
- Children with cerebral palsy aged 3 to 18 years who have a GMFCS level from I to V, with the ability to express discomfort or pain and understanding simple instructions
Who cannot join
- Medical problems that could interfere with training and restrictions on the use of the robotic device;
- severe lower limb conditions: muscle contractures, instability or subluxation of the hip;
- recent botulinum toxin A injections to the lower limbs;
- uncontrolled seizures;
- open skin disorders and vascular disorders of the lower limbs.
- Contraindications to gait rehabilitation treatment with Lokomat (e.g. weight <10 kg, non-consolidated fractures, cognitive deficits limiting communication).
- Contractures of fixed joints that limit the range of motion of the orthoses
- Inability to properly adjust the harness and/or orthoses
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Centri di Riabilitazione Padre Pio Onlus - Gli Angeli di Padre Pio
San Giovanni Rotondo, FG, 71013
Maria T. Gatta, Dr., dsangeli@centripadrepio.it
About this study
Official title: AID2GAIT: Biofeedback Based System to Enhance Robotic Assisted Gait Training in Children With Cerebral Palsy
The AID2GAIT project aims to develop a biofeedback system with the aim of improving the outcomes of robot-assisted gait training (RAGT) in pediatric patients with cerebral palsy. The physiological signals of children during RAGT therapy sessions, acquired through non-invasive technologies, will be analyzed. These technologies specifically are:
- wearable technology (smartwatch), from which the HRV (Heart Rate Variability) signal will be measured;
- infrared thermography, from which the temperature in salient facial regions will be obtained;
- fNIRS (functional near-infrared spectroscopy), from which information on brain activity and its changes over time will be obtained.
Read more
Information on the kinematics of the exoskeleton used during RAGT will be extracted.
The RAGT will be performed using the Lokomat orthosis (Hocoma), the most widely used exoskeleton in rehabilitation that facilitates a bilaterally symmetrical gait, as the individual actively tries to advance each limb during walking, combined with a patented dynamic body weight support system.
Read the detailed description
The entire RAGT treatment will consist of 12 sessions of robotic gait rehabilitation administered over 4 weeks.
The protocol consists of a block paradigm: children will be asked to actively move during the robotic training for the first 30 seconds, followed by a rest period of 30 seconds. The paradigm will be provided in 10 blocks for a total duration of 30 minutes. During each single session, infrared (IR) thermal video, smartwatch signals (HRV- heart rate variability) and the kinematic output of the robot will be recorded. During the first (T1) and the last session of the RAGT (T12), fNIRS will also be recorded together with the assessment of motor skills, revealed by clinical scales. The assessment of fNIRS and clinical scales will be useful to understand the global efficacy of the treatment. Before the start of the experimental trials, parents will be extensively informed about the purpose and protocol of the study and will sign an informed consent form.
For each session, the assessment of the psychophysiological state of the patients will be based on the estimation of the state of physiological parameters, such as heart rate variability (HRV), recorded by a smartwatch and on the assessment of the emotional state of the child by means of an infrared thermal imaging system. The information on the state of the child and the robot will be assessed in real time and will constitute the input data for a machine learning-based model capable of classifying the level of patient engagement. Based on this information, the physiotherapist, who assists the child during the training sessions, will be able to intervene and modify the parameters of the exoskeleton (e.g. push force, body weight support, treadmill speed, range of motion and hip and knee offset). Furthermore, the effectiveness of the entire treatment will be assessed through the administration of clinical tools commonly used in clinical practice and by the assessment of brain activation by means of a non-invasive and portable neuroimaging technique, the fNIRS. These assessments will be conducted by comparing the first and the last training session.
- Being tested
- RAGT
- Keywords
- Robotic Assisted Gait Training, Biofeedback, Infant Cerebral Palsy, Human-Robot Interaction, Exoskeleton
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAGTOther
Biofeedback based system development to enhance Robotic Assisted Gait Training in cerebral palsy pediatric patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of variations in the motor skills of patients from T0 (1st RAGT) to T2 (12th RAGT), assessed by GMFM88 clinical scale
Assessment by Gross Motor Function Measure (GMFM-88): it measure changes in GMF with intervention through 88 items. The scoring range is from 0 to 3 with higher scores meaning a better outcome.
The clinical scale is administered before RAGT#1 (i.e. T0) and after RAGT#12 (i.e. T2).
Measured: One month (4 weeks) from the beginning of the 1st RAGT (T0)
Analysis of variations in the motor skills of patients from T0 (1st RAGT) to T2 (12th RAGT), assessed by MAS clinical scale
Assessment by Modified Ashworth Scale (MAS): The test is performed by extending the patients limb's first from a position of maximal possible flexion to maximal possible extension. The scoring range is from 0 to 4 with lower scores meaning a better outcome.
The clinical scale is administered before RAGT#1 (i.e. T0) and after RAGT#12 (i.e. T2).
Measured: One month (4 weeks) from the beginning of the 1st RAGT (T0)
Analysis of variations in the motor skills of patients from T0 (1st RAGT) to T2 (12th RAGT), assessed by WeeFIM clinical scale
Assessment by Functional Independence Measure for Children (WeeFIM): it measures the need for assistance and the severity of disability. Scores range from 0 to 4, with lower scores indicating higher levels of disability.
The clinical scale is administered before RAGT#1 (i.e. T0) and after RAGT#12 (i.e. T2).
Measured: One month (4 weeks) from the beginning of the 1st RAGT (T0)
Analysis of variations in the motor skills of patients from T0 (1st RAGT) to T2 (12th RAGT), assessed by PEDSQL clinical scale
Assessment by Pediatric Quality of Life Inventory (PedsQL): modular approach to measuring health-related quality of life. The items of the four Scales (Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning) are grouped together. The scoring range is from 0 to 4 with lower scores meaning a better outcome.
The clinical scale is administered before RAGT#1 (i.e. T0) and after RAGT#12 (i.e. T2).
Measured: One month (4 weeks) from the beginning of the 1st RAGT (T0)
Measurement of heart rate variability of patients
During RAGT #1(i.e T0), RAGT#6 (i.e. T1), RAGT#12 (i.e. T2) heart rate variability (HRV) measurement will be performed by a smartwatch.
The HRV signal will be monitored and metrics such as mean, standard deviation, root mean square, power spectral density will be extracted in time windows of 30 seconds.
The above mentioned parameters are correlated with autonomous nervous system activity and will be used as input data for a AI based model able to classify the patient's engagement level during RAGT.
Measured: Two years from the beginning
Measurement of fNIRS of patients
During RAGT #1(i.e T0), RAGT#6 (i.e. T1), RAGT#12 (i.e. T2) functional near infrared spectroscopy measurement will be performed by a fNIRS cap.
fNIRS allows to measure oxy- and deoxyhemoglobin oscillations in the frontal, prefrontal and motor cortex areas. Given the ecological nature of the experiment, a GLM-based algorithm will be applied to automatically identify the onset and duration of cortical activations. The canonical GLM metrics (beta-values and t-statistics) indicative of brain activity will be evaluated in time windows of 30 seconds and averaged across all good channels.
The above mentioned parameters are correlated with central nervous system activity and will be used as input data for a AI based model able to classify the patient's engagement level during RAGT and to assess neural plasticity in patients.
Measured: Two years from the beginning
Measurement of infrared imaging of patients
During RAGT #1(i.e T0), RAGT#6 (i.e. T1), RAGT#12 (i.e. T2) infrared imaging (IRI) measurement will be acquired by an infrared camera.
The thermal signals in salient areas of the face (nose tip, nostrils, corrugator, chin, and perioral area) will be monitored (tempertures in °C), and metrics such as mean, standard deviation, kurtosis, skewness and LF ([0.04-0.15] Hz), HF ([0.15-0.4] Hz), and LF/HF components will be extracted in time windows of 30 seconds.
The above mentioned parameters are correlated with autonomous nervous system activity and will be used as input data for a AI based model able to classify the patient's engagement level during RAGT.
Measured: Two years from the beginning
Measurement of exoskeleton kinematics
During RAGT #1(i.e T0), RAGT#6 (i.e. T1), RAGT#12 (i.e. T2) the torques relative to both knees and both hips will be acquired (in Nm).
Metrics such as mean, standard deviation will be extracted in time inetrvals of 30 seconds.
The above mentioned parameters are correlated with the participation level and with the activity of the patient during RAGT and will be used as input data for a AI based model able to classify the patient's engagement level during RAGT.
Measured: Two years from the beginning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 Jul 2024
- Primary completion31 Mar 2025
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy InfantileStudies of the same condition, open and under way.
- 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
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Centri di Riabilitazione Padre Pio Onlus - Gli Angeli di Padre Pio
- Responsible party
- Principal investigator, Daniela Cardone, G. d'Annunzio University
- Investigators
- Daniela Cardone, Dr, Principal investigator, G. d'Annunzio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947889
- Sponsor's protocol ID
- D53D23021770001
- Acronym
- AID2GAIT
- Status last verified
- Apr 2025
- First submitted
- 25 Mar 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AID2GAIT: Biofeedback Based System to Enhance Robotic Assisted Gait Training in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06947889
- Acronym / sponsor ID
- AID2GAIT / D53D23021770001
- Keywords
- Robotic Assisted Gait Training, Biofeedback, Infant Cerebral Palsy, Human-Robot Interaction, Exoskeleton
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Collaborators
- Fondazione Centri di Riabilitazione Padre Pio Onlus - Gli Angeli di Padre Pio
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 27 Apr 2025 (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 AID2GAIT project aims to develop a biofeedback system with the aim of improving the outcomes of robot-assisted gait training (RAGT) in pediatric patients with cerebral palsy. The physiological signals of children during RAGT therapy sessions, acquired through non-invasive technologies, will be analyzed. These technologies specifically are:
- wearable technology (smartwatch), from which the HRV (Heart Rate Variability) signal will be measured;
- infrared thermography, from which the temperature in salient facial regions will be obtained;
- fNIRS (functional near-infrared spectroscopy), from which information on brain activity and its changes over time will be obtained.
Information on the kinematics of the exoskeleton used during RAGT will be extracted.
The RAGT will be performed using the Lokomat orthosis (Hocoma), the most widely used exoskeleton in rehabilitation that facilitates a bilaterally symmetrical gait, as the individual actively tries to advance each limb during walking, combined with a patented dynamic body weight support system.
Detailed description
The entire RAGT treatment will consist of 12 sessions of robotic gait rehabilitation administered over 4 weeks.
The protocol consists of a block paradigm: children will be asked to actively move during the robotic training for the first 30 seconds, followed by a rest period of 30 seconds. The paradigm will be provided in 10 blocks for a total duration of 30 minutes. During each single session, infrared (IR) thermal video, smartwatch signals (HRV- heart rate variability) and the kinematic output of the robot will be recorded. During the first (T1) and the last session of the RAGT (T12), fNIRS will also be recorded together with the assessment of motor skills, revealed by clinical scales. The assessment of fNIRS and clinical scales will be useful to understand the global efficacy of the treatment. Before the start of the experimental trials, parents will be extensively informed about the purpose and protocol of the study and will sign an informed consent form.
For each session, the assessment of the psychophysiological state of the patients will be based on the estimation of the state of physiological parameters, such as heart rate variability (HRV), recorded by a smartwatch and on the assessment of the emotional state of the child by means of an infrared thermal imaging system. The information on the state of the child and the robot will be assessed in real time and will constitute the input data for a machine learning-based model capable of classifying the level of patient engagement. Based on this information, the physiotherapist, who assists the child during the training sessions, will be able to intervene and modify the parameters of the exoskeleton (e.g. push force, body weight support, treadmill speed, range of motion and hip and knee offset). Furthermore, the effectiveness of the entire treatment will be assessed through the administration of clinical tools commonly used in clinical practice and by the assessment of brain activation by means of a non-invasive and portable neuroimaging technique, the fNIRS. These assessments will be conducted by comparing the first and the last training session.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with cerebral palsy aged 3 to 18 years who have a GMFCS level from I to V, with the ability to express discomfort or pain and understanding simple instructions
Key inclusion criteria (1 listed)
- Children with cerebral palsy aged 3 to 18 years who have a GMFCS level from I to V, with the ability to express discomfort or pain and understanding simple instructions
Key exclusion criteria (8 listed)
- Medical problems that could interfere with training and restrictions on the use of the robotic device;
- severe lower limb conditions: muscle contractures, instability or subluxation of the hip;
- recent botulinum toxin A injections to the lower limbs;
- uncontrolled seizures;
- open skin disorders and vascular disorders of the lower limbs.
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 |
|---|---|---|
| RAGTBiofeedback based system development to enhance Robotic Assisted Gait Training in cerebral palsy pediatric patients | Other | – |
Primary outcome
Analysis of variations in the motor skills of patients from T0 (1st RAGT) to T2 (12th RAGT), assessed by GMFM88 clinical scale
Time frame: One month (4 weeks) from the beginning of the 1st RAGT (T0)
Assessment by Gross Motor Function Measure (GMFM-88): it measure changes in GMF with intervention through 88 items. The scoring range is from 0 to 3 with higher scores meaning a better outcome. The clinical scale is administered before RAGT#1 (i.e. T0) and after RAGT#12 (i.e. T2).
Analysis of variations in the motor skills of patients from T0 (1st RAGT) to T2 (12th RAGT), assessed by MAS clinical scale
Time frame: One month (4 weeks) from the beginning of the 1st RAGT (T0)
Assessment by Modified Ashworth Scale (MAS): The test is performed by extending the patients limb's first from a position of maximal possible flexion to maximal possible extension. The scoring range is from 0 to 4 with lower scores meaning a better outcome. The clinical scale is administered before RAGT#1 (i.e. T0) and after RAGT#12 (i.e. T2).
Analysis of variations in the motor skills of patients from T0 (1st RAGT) to T2 (12th RAGT), assessed by WeeFIM clinical scale
Time frame: One month (4 weeks) from the beginning of the 1st RAGT (T0)
Assessment by Functional Independence Measure for Children (WeeFIM): it measures the need for assistance and the severity of disability. Scores range from 0 to 4, with lower scores indicating higher levels of disability. The clinical scale is administered before RAGT#1 (i.e. T0) and after RAGT#12 (i.e. T2).
Analysis of variations in the motor skills of patients from T0 (1st RAGT) to T2 (12th RAGT), assessed by PEDSQL clinical scale
Time frame: One month (4 weeks) from the beginning of the 1st RAGT (T0)
Assessment by Pediatric Quality of Life Inventory (PedsQL): modular approach to measuring health-related quality of life. The items of the four Scales (Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning) are grouped together. The scoring range is from 0 to 4 with lower scores meaning a better outcome. The clinical scale is administered before RAGT#1 (i.e. T0) and after RAGT#12 (i.e. T2).
Measurement of heart rate variability of patients
Time frame: Two years from the beginning
During RAGT #1(i.e T0), RAGT#6 (i.e. T1), RAGT#12 (i.e. T2) heart rate variability (HRV) measurement will be performed by a smartwatch. The HRV signal will be monitored and metrics such as mean, standard deviation, root mean square, power spectral density will be extracted in time windows of 30 seconds. The above mentioned parameters are correlated with autonomous nervous system activity and will be used as input data for a AI based model able to classify the patient's engagement level during RAGT.
Measurement of fNIRS of patients
Time frame: Two years from the beginning
During RAGT #1(i.e T0), RAGT#6 (i.e. T1), RAGT#12 (i.e. T2) functional near infrared spectroscopy measurement will be performed by a fNIRS cap. fNIRS allows to measure oxy- and deoxyhemoglobin oscillations in the frontal, prefrontal and motor cortex areas. Given the ecological nature of the experiment, a GLM-based algorithm will be applied to automatically identify the onset and duration of cortical activations. The canonical GLM metrics (beta-values and t-statistics) indicative of brain activity will be evaluated in time windows of 30 seconds and averaged across all good channels. The above mentioned parameters are correlated with central nervous system activity and will be used as input data for a AI based model able to classify the patient's engagement level during RAGT and to assess neural plasticity in patients.
Measurement of infrared imaging of patients
Time frame: Two years from the beginning
During RAGT #1(i.e T0), RAGT#6 (i.e. T1), RAGT#12 (i.e. T2) infrared imaging (IRI) measurement will be acquired by an infrared camera. The thermal signals in salient areas of the face (nose tip, nostrils, corrugator, chin, and perioral area) will be monitored (tempertures in °C), and metrics such as mean, standard deviation, kurtosis, skewness and LF ([0.04-0.15] Hz), HF ([0.15-0.4] Hz), and LF/HF components will be extracted in time windows of 30 seconds. The above mentioned parameters are correlated with autonomous nervous system activity and will be used as input data for a AI based model able to classify the patient's engagement level during RAGT.
Measurement of exoskeleton kinematics
Time frame: Two years from the beginning
During RAGT #1(i.e T0), RAGT#6 (i.e. T1), RAGT#12 (i.e. T2) the torques relative to both knees and both hips will be acquired (in Nm). Metrics such as mean, standard deviation will be extracted in time inetrvals of 30 seconds. The above mentioned parameters are correlated with the participation level and with the activity of the patient during RAGT and will be used as input data for a AI based model able to classify the patient's engagement level during RAGT.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- 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.
Daniela Cardone, Dr principal investigator
G. d'Annunzio University
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 Infantile and Robotic Assisted Gait Training, run by G. d'Annunzio University 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 8 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: looking for participants now, as of the sponsor's last update on 27 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniela Cardone, Dr (+39 085 453 7260, daniela.cardone@unich.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of variations in the motor skills of patients from T0 (1st RAGT) to T2 (12th RAGT), assessed by GMFM88 clinical scale (time frame: One month (4 weeks) from the beginning of the 1st RAGT (T0)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2025.