Effect of Neuromuscular Electrical Stimulation on Unilateral Central Facial Palsy

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.

Conditions

• Facial Palsy
• Stroke

Interventions

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.

Sponsors & Collaborators

• Danish Association of Occupational Therapist

  collaborator OTHER

• Hammel Neurorehabilitation Centre and University Research Clinic

  collaborator OTHER

• Hospital of Central Denmark Region, Denmark

  collaborator UNKNOWN

• University of Aarhus

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-27

Primary Completion

2030-12-15

Completion

2030-12-15

FDA Device

Yes

Countries

• Denmark

Study Locations