Cerebral Palsy
Conditions
Interventions
This concerns non-therapeutic intervention research with children. The research 
prototype presented in the study was created exclusively for research purposes 
(RUO) and has no medical (e.g. therapeutic) purpose in the research. The 
proposed research aims to collect data and gain knowledge on the (acute) effect 
of the prototype on the kinematics and kinetics of the user, and usability as a 
secondary goal. The device itself is not being developed into a medical device 
(with a medical purpose).
Sponsors
University of Twente
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: Participants with CP: - Children with a diagnosis of uni/bilateral CP; - Aged between 5 and 17 years; - GMFCS level I-II; - Sufficient cognitive skills: able to follow simple instructions; - Able to follow protocol walking time. It will be explained to the parents/caregivers that children must be able to walk on the treadmill for approximately half an hour, with short breaks provided. It is expected that caregivers will have a good understanding of the child*s ability and therefore their suitability to take part
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Functional surgery on bones and/or muscles of the legs in the last 6 months; - Lower limbs Botulin toxin A injection in the last 3 months; - Musculoskeletal deformities or unhealed skin lesions in the lower limbs that could prevent the use of the device - Shortening of the gastrocnemius (more than 10 degrees plantar flexion contracture) - Visual deficit that will hamper with the ability to perform the walking protocol - Behavioral problems of an extent that may impede normal subject cooperation as assessed by the treating physician - Comorbidities that affect walking, visual or cognitive abilities (e.g. frequent epilepsy) to an extent that makes subjects unfit to participate as assessed by the treating physician - Other lower-limb musculoskeletal problems not specified above
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| - Evaluate the subjects* preferences for ankle stiffness - Evaluate subjects* adaptation to the AFO - Evaluate subjects* feedback and motivation | — |
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to assess walking performance of the participants when using the inGAIT-AFO. Thus, we will evaluate whether the assistance at the ankle is effective in causing the desired changes in the walking pattern and it results in changes of the generated functional gait activity of the subject. To evaluate the walking performance, we envision two sub-studies, where will collect information that will be a compendium of different data among which: joint kinematics and kinetics, GRF, COM and COP trajectories and spatio-temporal parameters for both sub-studies. EMG of lower limb muscles will be also recorded for sub-study 2. From this data, we will use as main study parameter the propulsion force (GRF), and it will be considered that walking performance and gait efficiency has been (positively) affected if when using the prototype, the propulsion force at the moment of foot push is improved by at least 10% compared to when the user walks without the inGAIT prototype, maintaining the same ankle kinematics or approximating it to a healthy gait pattern. This main parameter (propulsion force) will be evaluated through both sub-studies, where the first one is meant to assess participant acceptance and usability and the second substudy is meant to assess the participant performance in an (acute) efficiency test. | — |
Countries
Netherlands
Contacts
Public ContactC Bayón-Calderón
University of Twente
Outcome results
None listed