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临床试验/NCT07325604
NCT07325604招募中不适用

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

University of Aarhus1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2026年2月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
130
试验地点
1
主要终点
My Facial Quantification (MyFacialQ)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Central facial palsy
  • First time stroke
  • >=18 years
  • Able to provide written consent

排除标准

  • Not able to cooperate for mimical exercises
  • Contraindications for NMES
  • Admitted for three weeks assessment stay at the hospital

研究组 & 干预措施

NMES

Experimental

NMES is provided as an add-on to usual care

干预措施: Neuromuscular electrical stimulation (NMES) (Device)

NMES

Experimental

NMES is provided as an add-on to usual care

干预措施: Usual Care (Other)

Usual care

Active Comparator

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

干预措施: Usual Care (Other)

结局指标

主要结局

My Facial Quantification (MyFacialQ)

时间窗: 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.

次要结局

  • Iowa Oral Performance Instrument (IOPI)(From enrollment to the end of treatment at four weeks)
  • Facial Clinimetric Evaluation (FACE)(From enrollment to three months follow-up after the intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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