Last reviewed · How we verify
NCT04591288: CP FES Walking
FES to Improve Gait in CP
NA trial testing Functional Electrical Stimulation protocol in Cerebral Palsy in 2 participants. Terminated before completion.
31 December 2019
Quick facts
| Lead sponsor | Shriners Hospitals for Children |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 2 |
| Start date | 24 October 2019 |
| Primary completion | 31 December 2019 |
| Estimated completion | 31 December 2019 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Functional Electrical Stimulation protocol
- Treadmill only protocol
Conditions studied
- Cerebral Palsy — all drugs for Cerebral Palsy →
- Spastic Diplegia Cerebral Palsy — all drugs for Spastic Diplegia Cerebral Palsy →
- Gait — all drugs for Gait →
Sponsor
Shriners Hospitals for Children
Who can join
Adults 10 to 18, any sex, with Cerebral Palsy or Spastic Diplegia Cerebral Palsy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04591288
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cerebral Palsy
Currently open trials in the same condition.
- NCT07524972 — Antenatal Magnesium Sulphate in High-Risk Preterm Patients · Phase 3 · recruiting
- NCT07432789 — Metrological Properties of a Digital Motion Analysis Research Application for Assessing the Motor Abilities and Performa · NA · recruiting
- NCT07466914 — Constipation in Children With Cerebral Palsy · active not recruiting
- NCT05901259 — The EXOPULSE Study - a Database for Routine Follow-up of Clinical Outcomes · recruiting
- NCT07342348 — Using Power Mobility Training to Promote Arm & Hand Function in Children With Cerebral Palsy · NA · recruiting
Other Shriners Hospitals for Children trials
Trials by the same sponsor.
- NCT06305689 — Defining Treatment Outcomes and Genetic Architecture in Idiopathic Toe Walking* · NA · completed
- NCT03940989 — The Impact of Dosing Parameters on Motor Skill Acquisition and Retention in Bilateral Cerebral Palsy (BCP) · NA · completed
- NCT03085420 — Cardiac Arrhythmias and Dysfunction in the Pediatric Burn Patient · NA · terminated
- NCT03560999 — Non-Anesthetized Plexus Technique for Infant (BPBP) MRI Evaluation · unknown
- NCT01870076 — The Effect of Healing Touch on Sleep · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04591288 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shriners Hospitals for Children
- Last refreshed: 19 October 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04591288.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing