Cerebral Palsy Clinical Trial
Official title:
Innovative Robotic Gait Trainer Use to Enable Walking in Children With Cerebral Palsy GMFCS III and IV
Exploration to optimize mixed quantitative and qualitative methodology using multiple outcome measures in a randomized, cross-over trial structure comparing the effect of robotic gait training (RGT) group, and functional clinical therapy (FCT) using each subject as their own control.
Exploration to optimize mixed quantitative and qualitative methodology using multiple outcome measures in a randomized, cross-over trial structure comparing the effect of robotic gait training (RGT) group, and functional clinical therapy (FCT) using each subject as their own control. The primary objective is to assess feasibility of the study design and device tolerability. Specifically: - Recruitment success (number screened, number eligible, number enrolled) where 80% of the recruitment target is reached. - Attrition rates of less than 10% (i.e. ≥90% of participant's successfully complete assessments). - Adherence for each participant: 80% of participants who complete assessments achieve the minimum target dose (i.e. approx. ≥30 hours of therapy in both study groups). - Qualitative feedback from clinicians and patients/caregivers on device tolerability and study participation. Secondary objectives will evaluate the distance a child can walk in two minutes using the Two Minute Walk Test (2MWT, 18) and will examine a more global impact of the use of this technology. Data collected will include quality of gait, child or proxy chosen individualized goals, hypertonicity, contractures, and bone health. ;
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