An observational study in Cerebral Palsy, sponsored by MarsiBionics. Active, not recruiting at 5 sites in Spain. Open to participants aged 3 Years to 14 Years. Per ClinicalTrials.gov, last updated 2024-09-27.
Sponsored by MarsiBionics · Observational
Cerebral Palsy (CP) is the first cause of motor disability in children worldwide. ATLAS 2030 is a robotic gait exoskeleton designed to rehabilitate children with motor disability. The objective of this study is to analyse the efficacy of a training program with ATLAS 2023 in chilren with CP.
A sample of children with CP will be divided into 2 groups, the experimental group will receive 32 sesions withe the ATLAS 2030 exoskeleton, whereas the control group will continue to receive their regular conventional therapy. Assessments will be performed at the beginning and the end of the intervention, as well as after 6, 9 and 12 months of the end of the intervention for follow-up.
750 studies on the registry are indexed under Paralysis; 133 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 199 observational studies indexed under Paralysis.
Browse Paralysis studies →MarsiBionics is the lead sponsor of 13 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children diagnosed with cerebral palsy with Gross Motor Function Classification level III (children walk using a hand-held mobility device in most indoor settings) or IV (children use methods of mobility that require physical assistance or powered mobility in most settings).
Exclusion Criteria:
sessions of rehabilitation with the ATLAS 2030 exoskeleton twice per week as part of their of their routine rehabilitation
Device: ATLAS 2030
The children included in the control group will continue receiving their usual conventional therapy
sessions of rehabilitation with the ATLAS 2030 exoskeleton twice per week as part of their routine rehabilitation
Gross Motor Function Measure-88 (GMFM-88)
To measure changes in gross motor function in children with cerebral palsy using the Gross Motor Functional Measure-88. The minimum value is 0 and the maximum value is 100 .When the GMFM score is lower, the skill level is lower.
Time frame: At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up)
Modified Ashworth Scale (MAS)
changes in spasticity measured by the Modified Ashworth Scale (MAS). The spasticity of each muscle group is measured with a scale scored from 0 to 4, where 0 means no spasticity and 4 means the joint is fixed and therefore, the highest level of spasticity
Time frame: Through study completion, along 1 year
Pediatric Quality of Life Inventory (PedsQLTM)
Changes in self perceived quality of life measured by the Pediatric Quality of Life Inventory (PedsQLTM). Every item is measured on a scale from 0 (higher quality of life) to 4 (lower quality of life)
Time frame: At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up)
Changes in Gait Deviation Index (GDI)
Changes in Gait Deviation Index (GDI) measured with a tridimensional motion analysis system
Time frame: At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up)
Plan to share: No
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This study is active, not recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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