Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03756571 · ClinicalTrials.gov registry record · NA
Cerebral Palsy: Ankle Foot Orthoses - Footwear Combinations
A NA study of Cerebral Palsy (CP), sponsored by Seattle Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT03756571 is a NA study of Cerebral Palsy (CP) that has completed, run by Seattle Children's Hospital. The registered enrollment target is 21 participants, below the 27-participant average among 7 other Cerebral Palsy (CP) trials with a reported enrollment target (22% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03756571, a NA study of Cerebral Palsy (CP), has completed, sponsored by Seattle Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
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?
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, categorized as NA. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 27-participant average among 7 other Cerebral Palsy (CP) trials with a reported enrollment target (22% lower). The listed sponsor is Seattle Children's Hospital, which has 168 total studies on file at ClinicalTrials.gov.
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.
NCT03756571 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
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).
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).
Who is sponsoring clinical trial NCT03756571?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
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
Similar trials for Cerebral Palsy (CP)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Robotic Knee Orthosis-assisted Walking in CP
RECRUITING · NA
-
Activities-based Locomotor Training in Children With Cerebral Palsy
RECRUITING · NA
-
Speech and Arm Combined Exergame
RECRUITING · NA
-
WBV and Serial Casting for Children with Cerebral Palsy
RECRUITING · NA
-
Effect of a Humanoid Robot With Virtual Reality Games to Train Arm Function in Children With Cerebral Palsy - THRIVE Trial
RECRUITING · NA
-
Pediatric Teleneuromodulation
COMPLETED · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.