Hammel neurorehabilitation centre and university research clinic
Hammel, 8450, Denmark
Location status: Recruiting
Location contact
Jesper Fabricius, PhD
CONTACT
Jesper Fabricius, PhD
PRINCIPAL_INVESTIGATOR
CONTACT
NCT Number: NCT07325604
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Hammel, 8450, Denmark
Location status: Recruiting
Jesper Fabricius, PhD
CONTACT
Jesper Fabricius, PhD
PRINCIPAL_INVESTIGATOR
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Electrical stimulation of facial muscles.
This arm receives usual care of facial palsy without NMES. Usual care encompass mimical exercises, facio oral sensory input, and kinesio taping.
Time frame: 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.
Time frame: From enrollment to the end of treatment at four weeks
Measurement of lip strength
Time frame: From enrollment to three months follow-up after the intervention
Patient reported outcome on facial palsy
Contact information is provided by the study sponsor or research team.
University of Aarhus
Other
Effect of Neuromuscular Electrical Stimulation on Unilaterial Central Facial Palsy: An Assesorblinded Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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