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临床试验/NCT03283839
NCT03283839Unknown不适用

Consequences of Temporomandibular Disorder on Balance Control

Central Hospital, Nancy, France2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年6月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
2
主要终点
Postural control (before care for patients)

研究概览

简要总结

To evaluate the effects of the temporomandibular disorder (TMD) and its therapeutic care on postural control in somato-sensory and visual sensitization compared to control subjects matched on age, sex and lifestyle.

Parameters will be estimated by measures realized before the therapeutic care of the TMD (T0), then 2, 3 and 5 months after the starting care, both in TMD patients and control subjects. To evaluate also the effects of the TMD and its therapeutic care on balance control in various contexts of multi-sensory stimulation, orientation function, pain and tinnitus.

详细描述

Primary objective: to evaluate the effects of the temporomandibular disorder (TMD) and its therapeutic care on postural control in somato-sensory and visual sensitization compared to control subjects matched on age, sex and lifestyle.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient group: TMD patients, care: occlusal splint therapy, behavioral advices
  • Control group: matched with TMD patients (age, sex, lifestyle).

排除标准

  • Patient group: treatment generating secondary effects in postural control (psychotrop, antidepressor, antihypertensive drugs); osteoarticular pathologies and recent trauma (< 4 months); vertigo and dysequilibrium (< 6 months), whiplash
  • Control group: id. and TMD.

研究组 & 干预措施

Temporomandibular disorder

Other

干预措施: Posturography (Diagnostic Test)

Without temporomandibular disorder

Other

干预措施: Posturography (Diagnostic Test)

结局指标

主要结局

Postural control (before care for patients)

时间窗: At inclusion (before care for patients) (first evaluation)

Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.

Postural control (during care for patients)

时间窗: 5 months after the first evaluation

Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.

次要结局

  • Balance function(T0 and 2,3 and 5 months after the first evaluation)
  • Orientation function(T0 and 2,3 and 5 months after the first evaluation)
  • Pain(T0 and 2,3 and 5 months after the first evaluation)
  • Tinnitus(T0 and 2,3 and 5 months after the first evaluation)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (2)

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