Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04591288 · ClinicalTrials.gov registry record · NA
FES to Improve Gait in CP
A NA study, sponsored by Shriners Hospitals for Children.
- Terminated
- Registry status
- NA
- Development phase
- 2
- Enrollment target
NCT04591288: Clinical Trial NA study, sponsored by Shriners Hospitals for Children.
NCT04591288 is a NA study that was terminated before completion, run by Shriners Hospitals for Children. The registered enrollment target is 2 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04591288, a NA study, was terminated before completion, sponsored by Shriners Hospitals for Children.
- TERMINATED
- Registry status
- NA
- Development phase
- 2 participants
- Enrollment target
Study Summary
The goal of this proposal is to mitigate the typical decline in walking function experienced by children with cerebral palsy (CP) via a Functional Electrical Stimulation (FES)-assisted treadmill training intervention. In this study, the investigators intend to use thier CP FES Gait Training System to assess the neurotherapeutic effects of an FES-assisted treadmill training intervention on walking performance in children with CP. The research design consists of a randomized, controlled, two-treatment study in which the control subjects will cross-over into one of the two treatment groups. An FES-assisted training group will undergo twelve weeks of FES-assisted treadmill training using a distributive practice protocol consisting of alternating bouts of walking with and without FES assistance, followed by over ground walking reinforcement. A treadmill-only training group will undergo the same training regimen without FES-assistance. Finally, a non-intervention group will serve as a control. The investigators will analyze treatment efficacy via functional and biomechanical and measures collected pre-training, post-training and after a twelve-week follow-up period.
Primary Outcome
We use the Modified Ashworth Scale to measure resistance to passive movement about a joint with varying degree of velocity (Muscle tone/spasticity). Score ranges from 0-4, with 6 choices where score of 0 means no increase in tone and score of 4 means rigid limb with no flexion or extension. Our training approach using repetitive electrical stimulation may also lower spasticity, which can also facilitate improved functional mobility.
Interventions
- OTHER Functional Electrical Stimulation protocol
- OTHER Treadmill only protocol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2019-10-24 |
| Est. Completion | 2019-12-31 |
| Phase | NA |
Why NCT04591288 stopped before completion
NCT04591288 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Functional Electrical Stimulation protocol is the first listed.
NCT04591288 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04591288 about?
NCT04591288 is a clinical study titled "FES to Improve Gait in CP". The goal of this proposal is to mitigate the typical decline in walking function experienced by children with cerebral palsy (CP) via a Functional Electrical Stimulation (FES)-assisted treadmill training intervention. In this study, the investigators intend to use thier CP FES Gait Training System ...
What is the current status of trial NCT04591288?
This trial is currently terminated. It is a NA study. The enrollment target is 2 participants. The study started on 2019-10-24. Estimated completion is 2019-12-31.
What interventions are being tested in trial NCT04591288?
The interventions under investigation include: Functional Electrical Stimulation protocol (OTHER), Treadmill only protocol (OTHER).
Who is sponsoring clinical trial NCT04591288?
This trial is sponsored by Shriners Hospitals for Children, which has 40 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04591288's enrollment target sits among peer trials
2 1997th of 2000 the lowest of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI