Facial Paralysis Clinical Trials

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Effect of Neuromuscular Electrical Stimulation on Unilaterial Central Facial Palsy: An Assesorblinded Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Central facial palsy

• First time stroke

• \>=18 years

• Able to provide written consent

Locations
Other Locations
Denmark
Hammel neurorehabilitation centre and university research clinic
RECRUITING
Hammel
Contact Information
Primary
Jesper Fabricius, PhD
jesperjm@hotmail.com
+4578419051
Time Frame
Start Date: 2026-02-27
Estimated Completion Date: 2030-12-15
Participants
Target number of participants: 130
Treatments
Experimental: NMES
NMES is provided as an add-on to usual care
Active_comparator: Usual care
This arm receives usual care of facial palsy without NMES. Usual care encompass mimical exercises, facio oral sensory input, and kinesio taping.
Related Therapeutic Areas
Sponsors
Collaborators: Danish Association of Occupational Therapist, Hospital of Central Denmark Region, Denmark, Hammel Neurorehabilitation Centre and University Research Clinic
Leads: University of Aarhus

This content was sourced from clinicaltrials.gov