Effect of Neuromuscular Electrical Stimulation on Unilateral Central Facial Palsy

NCT ID: NCT07325604

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-15

Study Completion Date

2030-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Facial Palsy Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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NMES

NMES is provided as an add-on to usual care

Group Type EXPERIMENTAL

Neuromuscular electrical stimulation (NMES)

Intervention Type DEVICE

Electrical stimulation of facial muscles.

Usual Care

Intervention Type OTHER

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

Usual care

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

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

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

Interventions

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Neuromuscular electrical stimulation (NMES)

Electrical stimulation of facial muscles.

Intervention Type DEVICE

Usual Care

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Association of Occupational Therapist

OTHER

Sponsor Role collaborator

Hammel Neurorehabilitation Centre and University Research Clinic

OTHER

Sponsor Role collaborator

Hospital of Central Denmark Region, Denmark

UNKNOWN

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jesper Fabricius, PhD

Role: PRINCIPAL_INVESTIGATOR

Hammel Neurorehabilitation Centre and University Research Clinic & Department of clinical medicine, Aarhus University

Locations

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Hammel neurorehabilitation centre and university research clinic

Hammel, , Denmark

Site Status

Countries

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Denmark

Central Contacts

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Jesper Fabricius, PhD

Role: CONTACT

+4578419051

Facility Contacts

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Jesper Fabricius, PhD

Role: primary

+4578419051

Role: backup

Other Identifiers

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2501205

Identifier Type: OTHER

Identifier Source: secondary_id

955087

Identifier Type: -

Identifier Source: org_study_id

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