Biofeedback Based System to Enhance Robotic Assisted Gait Training in Children With Cerebral Palsy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-18
SponsorG. d'Annunzio University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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;
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
RAGT
Other interventionBiofeedback based system development to enhance Robotic Assisted Gait Training in cerebral palsy pediatric patients
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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).
Time frame
One month (4 weeks) from the beginning of the 1st RAGT (T0)2
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).
Time frame
One month (4 weeks) from the beginning of the 1st RAGT (T0)3
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).
Time frame
One month (4 weeks) from the beginning of the 1st RAGT (T0)4
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).
Time frame
One month (4 weeks) from the beginning of the 1st RAGT (T0)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
G. d'Annunzio University
Lead sponsor
Fondazione Centri di Riabilitazione Padre Pio Onlus - Gli Angeli di Padre Pio
Collaborator
Source ClinicalTrials.gov