An interventional study of Modular customized AFO in Gait, Drop Foot, sponsored by Beat Göpfert. Completed at 1 site in Switzerland. Open to participants aged 11 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by Beat Göpfert · Not applicable, Interventional, and Screening
The Investigator will investigate the difference in the gait pattern between 2 commercially available ankle foot orthoses (AFO): a) conventionally manufactured AFO and b) modular customized AFO using Industry 4.0 technology.
Measurement method: The participants perform an instrumented gait analyses while overground walking at a self - selected speed using a conventionally manufactured AFO or a modular customized AFO.
Cerebral palsy (CP) is the most common movement disorder in children [Stavsky, 2017]. It is frequently accompanied by spasticity [Baker, 2009]. The typical symptoms of spastic cerebral palsy are gait abnormalities such as equinus and drop foot that lead to severe impairments in daily life [Armand, 2016]. As these symptoms will persist in adulthood, an AFO is frequently required in this patient population.
Furthermore, other neurological diseases e.g stroke [Choo, 2021], spinal cord injury, and peripheral nerve injury may require the daily use of an AFO.
Ankle-foot orthoses (AFO) have been suggested to improve the dynamic efficiency of the gait. In addition, a positive effects on gait kinetics and kinematics have been reported [Figueiredo, 2008].
Recently, modular customized AFO are increasingly proposed as their response can be tuned to the patient's gait characteristics and/or functional maturity [6]. However, the evidence on this topic is still lacking and modular customized AFO are not yet established in clinical routine.
The aim of this study is to assess gait parameters with an instrumented gait analysis of the modular customized AFO compared to conventional, untuned AFO in a group of adolescents and a group of adults using for there daily activity an AFO, while over ground walking at self selected speed over a distance of about 10 m.
340 studies on the registry are indexed under Gait Disorders, Neurologic; 55 are open to participants now.
This study's enrollment of 15 is below the median of 30 across 255 interventional studies indexed under Gait Disorders, Neurologic.
Browse Gait Disorders, Neurologic studies →This is the only study on the registry with Beat Göpfert as lead sponsor.
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Participants fulfilling all of the following inclusion criteria are eligible for the study:
Exclusion Criteria:
Walks better at self selected speed with a modular customized AFO than with a conventional AFO.
Device: Modular customized AFO
Walks better at self selected speed with a modular customized AFO than with a conventional AFO.
Gait Profile Score (GPS)
The primary outcome measure is the gait profile score (GPS), which is an overall score calculated from all kinematic parameters (joint rotation angles) of the affected leg and expressed as the deviation from the normal gait cycle in degrees. The outcome of the GPS will be compared between the conventional AFO, and modular customized AFO for each participant and for each group.
Time frame: immediately after the intervention (gait analysis)
Movement Analysis Profile (MAP) and spatial-temporal parameters
Secondary outcomes are the Movement analysis profile (MAP) and spatial-temporal parameters, both calculated from kinematic parameters and expressed as the deviation from the normal gait cycle in degrees. The MAP consists of individual scores for each joint rotation angle (pelvic tilt, pelvic obliquity, pelvic rotation, hip flexion/extension, hip abduction/adduction, hip rotation, knee flexion/extension, ankle dorsiflexion/extension and foot progression) of the affected leg \[2\]. Spatial-temporal parameters are walking speed (m/s), cadence (steps/min x 100) and stride length (m) of the affected leg. The above-mentioned parameters will be compared between the conventional AFO, and modular customized AFO for each participant and for each group.
Time frame: immediately after the intervention (gait analysis)
Plan to share: No
Ran from Feb 2022 to primary completion in Dec 2023, 22 months.
Of 181 non-industry interventional studies with no phase under Gait Disorders, Neurologic, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's 22 months is above that.
Counting every sponsor, half of 194 studies reached it within 14 months; a quarter within 5 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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