Effect of Neuromuscular Electrical Stimulation on Unilateral Central Facial Palsy

University of Aarhus

Status: Begins enrollment this month

Conditions: Stroke; Facial Palsy

Treatments: Device: Neuromuscular electrical stimulation (NMES); Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07325604

2501205 (Other Identifier)

955087

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

NMES

Experimental group

Description:

NMES is provided as an add-on to usual care

Treatment:

Other: Usual Care

Device: Neuromuscular electrical stimulation (NMES)

Usual care

Active Comparator group

Description:

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

Treatment:

Other: Usual Care