Evaluation of Functional Recovery of Facial Paralysis in People With Different Kinesic Treatment Options.
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
- 否
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
Jessica Andrea Isabel Zalazar Cinat
Master in Research in Health Sciences - Graduate in Kinesiology and Physiatry
Universidad Nacional del Nordeste, Argentina
