Effect of Neuromuscular Electrical Stimulation on Unilateral Central Facial Palsy

March 6, 2026 updated by: University of Aarhus

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Hammel, Denmark, 8450
        • Recruiting
        • Hammel neurorehabilitation centre and university research clinic
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jesper Fabricius, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NMES
NMES is provided as an add-on to usual care
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
My Facial Quantification (MyFacialQ)
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.
From enrollment to the end of treatment at four weeks"

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Iowa Oral Performance Instrument (IOPI)
Time Frame: From enrollment to the end of treatment at four weeks
Measurement of lip strength
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
Patient reported outcome on facial palsy
From enrollment to three months follow-up after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Hammel Neurorehabilitation Centre and University Research Clinic
Danish Association of Occupational Therapist
Hospital of Central Denmark Region, Denmark

Investigators

  • Principal Investigator: Jesper Fabricius, PhD, Hammel Neurorehabilitation Centre and University Research Clinic & Department of clinical medicine, Aarhus University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2026

Primary Completion (Estimated)

December 15, 2030

Study Completion (Estimated)

December 15, 2030

Study Registration Dates

First Submitted

January 7, 2026

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 955087
  • 2501205 (Other Identifier: Medical Research Ethics Committees)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD raw data is mainly video recordings, and these will not be shared. However aggregated measures from the video recordings may be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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