Background: A combined vestibular (VI) and cochlear implant (CI) device, also known as the vestibulocochlear implant (VCI), was previously developed to restore both vestibular and auditory function. A new refined prototype is currently being investigated. This prototype allows for concurrent multichannel vestibular and cochlear stimulation. Although recent studies showed that VCI stimulation enables compensatory eye, body and neck movements, the constraints in these acute study designs prevent them from creating more general statements over time. Moreover, the clinical relevance of potential VI and CI interactions is not yet studied. The VertiGO! Trial aims to investigate the safety and efficacy of prolonged daily motion modulated stimulation with a multichannel VCI prototype. Methods: A single-center clinical trial will be carried out to evaluate prolonged VCI stimulation, assess general safety and explore interactions between the CI and VI. A single-blind randomized controlled crossover design will be implemented to evaluate the efficacy of three types of stimulation. Furthermore, this study will provide a proof-of-concept for a VI rehabilitation program. A total of minimum eight, with a maximum of 13, participants suffering from bilateral vestibulopathy and severe sensorineural hearing loss in the ear to implant will be included and followed over a five-year period. Efficacy will be evaluated by collecting functional (i.e. image stabilization) and more fundamental (i.e. vestibulo-ocular reflexes, self-motion perception) outcomes. Hearing performance with a VCI and patient-reported outcomes will be included as well. Discussion: The proposed schedule of fitting, stimulation and outcome testing allows for a comprehensive evaluation of the feasibility and long-term safety of a multichannel VCI prototype. This design will give insights into vestibular and hearing performance during VCI stimulation. Results will also provide insights into the expected daily benefit of prolonged VCI stimulation, paving the way for cost-effectiveness analyses and a more comprehensive clinical implementation of vestibulocochlear stimulation in the future. Trial registration: ClinicalTrials.gov: NCT04918745. Registered 28 April 2021.
For clinical use, the processed data is also presented and visualized per age group (3-6 years, 7-8 years, 9-10 years, 11-12 years, ≥13 years). For each speed condition, spatiotemporal parameters, joint angles, joint moments and joint power for both legs are presented per age group. These data are presented in tables and visualized in waveforms and can serve as normative values for treadmill based 3D gait analyses. Data is available at OSF.io (DOI 10.17605/OSF.IO/3XQEW).
Fatigue during walking is a common complaint in cerebral palsy (CP). The primary purpose of this study is to investigate muscle fatigue from surface electromyography (sEMG) measurements after a treadmill-based fatigue protocol with increasing incline and speed in children with CP with drop foot. The secondary purpose is to investigate whether changes in sagittal kinematics of hip, knee and ankle occur after fatigue. Eighteen subjects with unilateral spastic CP performed the protocol while wearing their ankle-foot orthosis and scored their fatigue on the OMNI scale of perceived exertion. The median frequency (MF) and root mean square (RMS) were used as sEMG measures for fatigue and linear mixed effects model were applied. The MF was significantly decreased in fatigued condition, especially in the affected leg and in the tibialis anterior and peroneus longus muscle. The RMS did not change significantly in fatigued condition, while the OMNI fatigue score indicated patients felt really fatigued. No changes in sagittal kinematics of hip, knee and ankle were found using statistical non-parametric mapping. In conclusion, the current fatigue protocol seems promising in inducing fatigue in a population with CP with drop foot and it could be used to expand knowledge on muscle fatigue during walking in CP.
29 December 2023 in North American Spine Society Journal (NASSJ)
Adult spinal deformity patients (ASD) experience altered spinal alignment affecting spatiotemporal parameters and joint kinematics. Differences in spinal deformity between patients with symptomatic idiopathic scoliosis (ID-ASD) and patients with “de novo” scoliosis (DN-ASD) may affect gait characteristics differently. This study aims to compare gait characteristics between ID-ASD, DN-ASD, and asymptomatic healthy matched controls. In this observational case-control study, ID-ASD (n = 24) and DN-ASD (n = 26) patients visiting the out-patient spine clinic and scheduled for long-segment spinal fusion were included. Patients were matched, based on age, gender, leg length and BMI, with asymptomatic healthy controls. Gait was measured at comfortable walking speed on an instrumented treadmill with 3D motion capture system. Trunk, pelvic and lower extremities range of motion (ROM) and spatiotemporal parameters (SPT) are presented as median (first and thirds quartile). Independent t-test or Mann–Whitney U test was used to compare ID-ASD, DN-ASD and controls. Statistical Parametric Mapping (independent t-test) was used to compare 3D joint kinematics. DN-ASD patients walk with increased anterior trunk tilt during the whole gait cycle compared with ID-ASD patients and controls. ID-ASD walk with decreased trunk lateroflexion compared with DN-ASD and controls. DN-ASD showed decreased pelvic obliquity and -rotation, increased knee flexion, and decreased ankle plantar flexion. ID-ASD and DN-ASD displayed decreased trunk, pelvic and lower extremity ROM compared with controls, but increased pelvic tilt ROM. ID-ASD patients walked with comparable SPT to controls, whereas DN-ASD patients walked significantly slower with corresponding changes in SPT and wider steps. DN-ASD patients exhibit distinct alterations in SPT and kinematic gait characteristics compared with ID-ASD and controls. These alterations seem to be predominantly influenced by sagittal spinal malalignment and kinematic findings in ASD patients should not be generalized as such, but always be interpreted with consideration for the nature of the ASD.