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临床试验/NCT06532903
NCT06532903招募中不适用

Evaluation of Functional Recovery of Facial Paralysis in People With Different Kinesic Treatment Options.

Universidad Nacional del Nordeste, Argentina2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
2
主要终点
Functional recovery time

研究概览

简要总结

This is a controlled, single-blind (hybrid) clinical investigation that aims to analyze the process of recovery of muscle function in people with peripheral facial paralysis who receive kinesthetic treatment with electrostimulation compared to those who receive treatment without electrostimulation, in the UNNE University Kinesiology Service, during the period 2023-2025, to promote early reintegration into their social activities of daily life.

An initial evaluation will be carried out, the movements that cause the requested gestures will be observed and recorded and recorded on a monitoring sheet and on video. The House Brackman and Sunnybrook scale will be used to measure functional outcomes. The initial and final evaluations will be external and blind. Patients will sign informed consent approved by Resolution No 04/23 of the Health Sciences Research Bioethics Committee.

The following inclusion criteria will be taken into account: patients with a medical referral that indicates a diagnosis of peripheral facial paralysis, Bell's palsy, frigori facial paralysis, idiopathic facial paralysis, who have not received previous kinesic treatment. Patients with central facial paralysis (associated with stroke), with peripheral facial paralysis of more than 6 months of evolution, who present dermal lesions that interfere with the application of electrical currents (open wounds, lacerations or burns) will be excluded from the study. ) In addition, those patients who attend with a medical prescription that advises in writing against the use of electrostimulation will be excluded.

详细描述

Methodology:

Study type: experimental Design: Controlled clinical research, single blind (hybrid). Universe: all people with peripheral facial paralysis or Bell's palsy in the City of Corrientes.

Units of analysis: each person with peripheral facial paralysis or Bell's palsy who attends the UNNE University Kinesiology Service. This center is taken as a reference, since it is a reference place for the referral of patients with this diagnosis, it is open to the general public and free of charge.

Sampling: a probabilistic sampling will be carried out. Sample size (n): 152 patients Expected loss ratio (R): 15% Loss-adjusted sample: 179 patients

The following inclusion criteria will be taken into account:

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
None

盲法说明

The external evaluators will determine the degree of facial dysfunction according to House Brackman and the score found in the Sunnybrook system, values that will be recorded on a blind evaluation sheet. The procedure will be carried out after the first session and upon discharge of the patients. That is, they will carry out an initial and final evaluation of the patients, without knowing the physical treatment they received.

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with a medical referral that indicates as a diagnosis:
  • Peripheral facial paralysis
  • Bell's palsy
  • Frigori facial paralysis
  • Idiopathic facial paralysis, who have NOT received prior kinesic treatment.

排除标准

  • Patients with central facial paralysis (facial paralysis associated with stroke)
  • Patients with peripheral facial paralysis of more than 6 months' duration, will be excluded from the study.
  • Patients who present skin lesions that interfere with the application of electrical currents (open wounds, lacerations or burns)
  • Patients who attend with a medical prescription that advises against the use of electrostimulation in writing.

结局指标

主要结局

Functional recovery time

时间窗: 24 months

number of sessions necessary to achieve recovery of facial muscle function and ability to make facial gestures.

FUNCTIONAL RECOVERY

时间窗: 24 months

ability to make facial gestures evaluated using the House Brackman scale and the Sunnybroock system

次要结局

未报告次要终点

研究者

发起方
Universidad Nacional del Nordeste, Argentina
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jessica Andrea Isabel Zalazar Cinat

Master in Research in Health Sciences - Graduate in Kinesiology and Physiatry

Universidad Nacional del Nordeste, Argentina

研究点 (2)

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