Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 8:48 PM
Study NCT ID:
NCT07325604
Status:
RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Neuromuscular Electrical Stimulation on Unilateral Central Facial Palsy
Sponsor:
University of Aarhus
Organization:
Study Overview
Official Title:
Effect of Neuromuscular Electrical Stimulation on Unilaterial Central Facial Palsy: An Assesorblinded Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Central facial palsy (CFP) is a common condition in stroke, with an estimated prevalence of 45%. CFP can lead to facial asymmetry, problems with mouth closure and food processing, bite marks on the cheek, social isolation, and reduced quality of life. CFP is seen as an important area of rehabilitation, and training is therefore often carried out to reduce the consequences of CFP. In a recent systematic review conducted by the principal investigator, the results showed that very few studies have been conducted that have investigated the effect of training for CFP, and there is currently no scientific evidence to support the effect of the various training interventions.
Objective To investigate the effect of Neuromuscular electrical stimulation (NMES) on facial symmetry compared to usual practice, in participants with CFP as a result of stroke.
Hypothesis: Participants who receive training with NMES together with usual training for facial paralysis have greater improvement in facial symmetry than participants who only receive usual training for facial paralysis.
Trial design Randomized controlled trial (RCT) with a nested pilot trial. A pilot trial/RCT will be conducted in order to power calculation in an RCT. The protocol for the pilot trial and RCT will be the same, and participants from the pilot trial and their outcome data are thus expected to be included in the RCT.
Objective To investigate the effect of Neuromuscular electrical stimulation (NMES) on facial symmetry compared to usual practice, in participants with CFP as a result of stroke.
Hypothesis: Participants who receive training with NMES together with usual training for facial paralysis have greater improvement in facial symmetry than participants who only receive usual training for facial paralysis.
Trial design Randomized controlled trial (RCT) with a nested pilot trial. A pilot trial/RCT will be conducted in order to power calculation in an RCT. The protocol for the pilot trial and RCT will be the same, and participants from the pilot trial and their outcome data are thus expected to be included in the RCT.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2501205 | OTHER | Medical Research Ethics Committees | View |