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NCT Number: NCT07325604

Effect of Neuromuscular Electrical Stimulation on Unilateral Central Facial Palsy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hammel neurorehabilitation centre and university research clinic

Hammel, 8450, Denmark

Location status: Recruiting

Location contact

Jesper Fabricius, PhD

CONTACT

[email protected]

+4578419051

Jesper Fabricius, PhD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuromuscular Electrical Stimulation (NMES)

Device

Electrical stimulation of facial muscles.

Usual Care

Other

This arm receives usual care of facial palsy without NMES. Usual care encompass mimical exercises, facio oral sensory input, and kinesio taping.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Iowa Oral Performance Instrument (IOPI)

    Time frame: From enrollment to the end of treatment at four weeks

    Measurement of lip strength

  2. Facial Clinimetric Evaluation (FACE)

    Time frame: From enrollment to three months follow-up after the intervention

    Patient reported outcome on facial palsy

Study contacts

Contact information is provided by the study sponsor or research team.

Jesper Fabricius, PhD

CONTACT

[email protected]

+4578419051

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jan 8, 2026
Registry last updated
Mar 9, 2026

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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