Effect of Neuromuscular Electrical Stimulation on Unilateral Central Facial Palsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Aarhus
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Central facial palsy
First time stroke
>=18 years
Able to provide written consent
Disqualifiers
Not able to cooperate for mimical exercises
Contraindications for NMES
Admitted for three weeks assessment stay at the hospital
Trial design
Design model
Parallel
Treatments tested in this trial
Neuromuscular electrical stimulation (NMES)
DeviceElectrical stimulation of facial muscles.
Usual Care
Other interventionThis arm receives usual care of facial palsy without NMES. Usual care encompass mimical exercises, facio oral sensory input, and kinesio taping.
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: NMESExperimental treatment 2 interventions
Group B: Usual careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
My Facial Quantification (MyFacialQ)
MyFacialQ quantifies degree of unilateral facial palsy through video recordings of mimical exercises. The development and validation study for MyFacialQ is in review.
Time frame
From enrollment to the end of treatment at four weeks"Secondary outcomes
1
Iowa Oral Performance Instrument (IOPI)
Measurement of lip strength
Time frame
From enrollment to the end of treatment at four weeks2
Facial Clinimetric Evaluation (FACE)
Patient reported outcome on facial palsy
Time frame
From enrollment to three months follow-up after the interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Aarhus
Lead sponsor
Danish Association of Occupational Therapist
Collaborator
Hammel Neurorehabilitation Centre and University Research Clinic
Collaborator
Hospital of Central Denmark Region, Denmark
Collaborator
Source ClinicalTrials.gov