Biofeedback Based System to Enhance Robotic Assisted Gait Training in Children With Cerebral Palsy

NCT06947889 | Recruiting

• 1 other identifier: D53D23021770001
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cerebral Palsy Infantile; Robotic Assisted Gait Training

Keywords

Robotic Assisted Gait Training; Biofeedback; Infant Cerebral Palsy; Human-Robot Interaction; Exoskeleton

Outcome Measures

Primary Outcomes (8)

• 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).

  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).

  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).

  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).

  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.

  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.

  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.

  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.

  Two years from the beginning

Interventions

RAGT OTHER

Biofeedback based system development to enhance Robotic Assisted Gait Training in cerebral palsy pediatric patients

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• G. d'Annunzio University: lead
• Fondazione Centri di Riabilitazione Padre Pio Onlus - Gli Angeli di Padre Pio: collaborator

Study Sites (1)

Fondazione Centri di Riabilitazione Padre Pio Onlus - Gli Angeli di Padre Pio

San Giovanni Rotondo, FG, 71013, Italy

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Daniela Cardone, Dr

  G. d'Annunzio University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela Cardone, Dr

CONTACT

+39 085 453 7260; daniela.cardone@unich.it

Teresa Paolucci, Prof.

CONTACT

+3908713551; teresa.paolucci@unich.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 27, 2025
• Study Start: July 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: February 28, 2026
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)