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临床试验/NCT06982833
NCT06982833已完成不适用

Investigation of the Effect of Trunk Restraint on Upper Extremity Functionality in Individuals With Multiple Sclerosis

Zonguldak Bulent Ecevit University2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2025年3月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
96
试验地点
2
主要终点
Expanded Disability Status Scale (EDSS)

研究概览

简要总结

This study examined the effect of trunk restraint on upper extremity functionality in patients with Multiple Sclerosis (MS).The study included 66 MS patients over the age of 18 and 30 healthy individuals. Participants' upper extremity functions were assessed. Their trunks were then restrained and their upper extremity functions were assessed again. The patients' level of disability (EDSS), trunk control (Trunk Impairment Scale - TIS), upper extremity functionality (Nine Hole Peg Test- 9HPT), were evaluated.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Being over 18 years old
  • •Being diagnosed with MS
  • •Volunteering

排除标准

  • •Having any additional disease or disorder of the upper extremity or trunk (such as disc herniation, fracture)
  • •Having any additional neurological disease

研究组 & 干预措施

Multiple Sclerosis

Experimental

Patients and healthy individuals first filled out the demographic and clinical information form. Then, the Trunk Impairment Scale was evaluated. Participants performed 9DPT with their trunks free and again with their trunks restrained.

干预措施: Trunk restraint (Other)

结局指标

主要结局

Expanded Disability Status Scale (EDSS)

时间窗: up to 6 weeks

EDSS was used to determine the patients' level of disability. EDSS is most commonly used to assess the level of disability in persons with MS. In this scale pyramidal, cerebral, cerebellar, brainstem, visual and sensory subparameters are evaluated it consists of ordinal rating system ranging from 0 (normal neurological status) to 10 (death due to MS) in 0.5 increments interval (when reaching EDSS 1). The lower scale values of the EDSS measureimpairments based on the neurological examination, while the upper range of the scale (\> EDSS 6) measures handicaps of patients with MS. The determination of EDSS 4 - 6 is heavily dependent on aspects of walking ability.

Trunk Impairment Scale (TIS)

时间窗: up to 6 weeks

This scale used to evaluate the trunk control of the participants, TIS contains static sitting balance, dynamic sitting balance, and coordination. The total score of this scale is from 0 to 23 and a high score indicates better trunk control. The patients were placed in the standard sitting position for the test and the parameters were applied. Standart position is such that the knees are flexed at 90 degrees, without back support, with the hands and forearms on the thighs and the feet in contact with the ground.

Nine-Hole Peg Test (9HPT)

时间窗: up to 6 weeks

It is a short, standardized, quantitative test used to evaluate upper extremity function. In the test, patients are asked to pick up nine wooden pegs from a platform as quickly as possible and then place them back into the holes.In our study, the test was conducted twice for both the dominant and non-dominant hands, and the average completion time was recorded.

次要结局

未报告次要终点

研究者

发起方
Zonguldak Bulent Ecevit University
申办方类型
Other
责任方
Principal Investigator
主要研究者

ARZUCAN TOKSAL UÇAR

PhD

Zonguldak Bulent Ecevit University

研究点 (2)

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