Facial Palsy, Stroke
Conditions
Keywords
NMES, Central facial palsy, Multicenter RCT, Stroke, Facial symmetry
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.
Interventions
DEVICENeuromuscular electrical stimulation (NMES)
Electrical stimulation of facial muscles.
OTHERUsual Care
This arm receives usual care of facial palsy without NMES. Usual care encompass mimical exercises, facio oral sensory input, and kinesio taping.
Sponsors
University of Aarhus
Danish Association of Occupational Therapist
Hammel Neurorehabilitation Centre and University Research Clinic
Hospital of Central Denmark Region, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| My Facial Quantification (MyFacialQ) | From enrollment to the end of treatment at four weeks" | MyFacialQ quantifies degree of unilateral facial palsy through video recordings of mimical exercises. The development and validation study for MyFacialQ is in review. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Iowa Oral Performance Instrument (IOPI) | From enrollment to the end of treatment at four weeks | Measurement of lip strength |
| Facial Clinimetric Evaluation (FACE) | From enrollment to three months follow-up after the intervention | Patient reported outcome on facial palsy |
Countries
Denmark
Contacts
CONTACTJesper Fabricius, PhD
PRINCIPAL_INVESTIGATORJesper Fabricius, PhD
Hammel Neurorehabilitation Centre and University Research Clinic & Department of clinical medicine, Aarhus University
Outcome results
None listed