Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Cerebral Palsy: Ankle Foot Orthoses - Footwear Combinations
NCT03756571 · View on ClinicalTrials.gov ↗
Study Summary
Ambulatory children with cerebral palsy (CP) demonstrate altered lower limb biomechanical alignment in walking (e.g. excessive hip/knee flexion or equinus during stance) and experience walking activity limitations that negatively influence their ability to participate in day to day life. Ankle Foot Orthoses (AFO) are a fundamental rehabilitation strategy to facilitate walking in children with CP; yet, a review suggests that efficacy of the "traditional" solid AFO (TSAFO) in this population remains equivocal. A novel decision tree to guide orthotic prescription proposes a patient-specific method for adjusting AFO alignment and integrating footwear modifications (Ankle Foot Orthoses-Footwear Combinations, AFO-FC). This approach is based on visualizing the sagittal plane orientation of the ground reaction force vector with respect to lower limb segments during gait. The AFO-FC represents a paradigm shift in orthotic management as it accommodates ankle equinus contractures in a rigid AFO, reorients the tibial segment with a heel wedge under the AFO, and applies different heel, midsole and forefoot shoe modifications to restore lost ankle-foot rockers. The primary goal of AFO-FCs are to improve stability by facilitating more normal segment kinematics in single limb stance, decreasing hip/knee flexion. Despite their promise, evidence of an immediate positive effect on midstance alignment is limited, with no evidence of clinical effectiveness. This proposal assesses the feasibility of using a randomized waitlist study to acquire pilot data on a targeted clinical cohort of children with CP evaluating the effectiveness of AFO-FCs as compared to TSAFO during daily life. Individual joint and combined kinematics and kinetics will be examined for potential mechanisms of action as well as daily walking performance, balance and satisfaction with the AFO-FC in 30 ambulatory children with CP, ages 4-9 years, with bilateral crouch or equinus gait pattern, comparing gait in TSAFO to
Conditions Studied
Interventions
- OTHER Ankle Foot Orthoses-Footwear Combination
- OTHER Traditional Solid Ankle AFO (TSAFO)
Study Locations (1)
Washington
- Seattle Children's Research Institute — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2018-12-17 |
| Est. Completion | 2021-09-01 |
| Phase | NA |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03756571
The ClinicalTrials.gov registry entry for NCT03756571 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seattle Children's Hospital, which has 127 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Cerebral Palsy (CP) appearing as the primary indexed condition, and to 2 interventions — of which Ankle Foot Orthoses-Footwear Combination is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03756571 reports 1 study location spanning 1 distinct geographic area — top geographies include Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03756571 about?
NCT03756571 is a clinical study titled "Cerebral Palsy: Ankle Foot Orthoses - Footwear Combinations". Ambulatory children with cerebral palsy (CP) demonstrate altered lower limb biomechanical alignment in walking (e.g. excessive hip/knee flexion or equinus during stance) and experience walking activity limitations that negatively influence their ability to participate in day to day life. Ankle Foot ...
What is the current status of trial NCT03756571?
This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2018-12-17. Estimated completion is 2021-09-01.
What conditions does trial NCT03756571 study?
This clinical trial studies the following conditions: Cerebral Palsy (CP). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03756571?
The interventions under investigation include: Ankle Foot Orthoses-Footwear Combination (OTHER), Traditional Solid Ankle AFO (TSAFO) (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03756571?
This trial is sponsored by Seattle Children's Hospital, which has 127 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03756571 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.