Effect of Neuromuscular Electrical Stimulation on Unilateral Central Facial Palsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neuromuscular electrical stimulation (NMES), Usual Care.
- Who it may be relevant to
- Registry conditions: Facial Palsy, Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Neuromuscular Electrical Stimulation on Unilaterial Central Facial Palsy: An Assesorblinded Randomized Controlled Trial
Overview
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.
Interventions
- Device Neuromuscular electrical stimulation (NMES)
Electrical stimulation of facial muscles. - Other Usual Care
This arm receives usual care of facial palsy without NMES. Usual care encompass mimical exercises, facio oral sensory input, and kinesio taping.
Primary outcome measures
- My Facial Quantification (MyFacialQ) [Time frame: From enrollment to the end of treatment at four weeks"]
Secondary outcome measures (2)
- Iowa Oral Performance Instrument (IOPI) [Time frame: From enrollment to the end of treatment at four weeks]
- Facial Clinimetric Evaluation (FACE) [Time frame: From enrollment to three months follow-up after the intervention]
Eligibility criteria
Inclusion criteria
- Central facial palsy
- First time stroke
- >=18 years
- Able to provide written consent
Exclusion criteria
- Not able to cooperate for mimical exercises
- Contraindications for NMES
- Admitted for three weeks assessment stay at the hospital
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Hammel neurorehabilitation centre and university research clinic — Hammel
Identifiers
NCT: NCT07325604 · 955087 · 2501205