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临床试验/NCT04543448
NCT04543448已完成不适用

Investigation the Effect of Cervical Mobilization on Balance and Plantar Pressure Distribution in Multiple Sclerosis Patients: A Randomized Crossover Controlled Study

Hasan Kalyoncu University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
1
主要终点
Change Balance

研究概览

简要总结

MS patients were randomly divided into traditional therapy and traditional therapy + cervical mobilization groups. While muscle strengthening, stretching, balance and coordination exercises were given to the traditional group, cervical mobilization was applied in addition to these in cervical group. Patients received treatments twice a week for 4 weeks. The effect of the applied treatment on the tonus and plantar pressure distribution was analyzed. Treatments were interrupted for 4 weeks and the groups continued with the treatment they did not receive (crossover design). The group that received traditional treatment in the first period completed traditional + cervical mobilization, and the other group with traditional + cervical mobilization traditionally completed the treatment.

详细描述

Cervical region is rich in terms of muscle spindle and reseptors. When this region is touched by physiotherapists, muscle spindles is activited. The cervical region is parasympathetic area have common relaxed effect. Thus this part can be benefit to improvement of balance. As improve balance, the plantar pressure distribution of patients may change.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

  • Expanded Disability Status Scale (EDSS) score was between 2-5,
  • According to the modified Ashworth Scale, spasticity is between 1 and 3,
  • EDSS Cerebellar System Sub-Scale, Functional System Score ˃1,
  • medical condition is stable and no medication changes were made in the last month,
  • Vertebro-basillar test negative,
  • Not have any other neurological disorder and orthopedic problem to prevent participation in this study
  • A score of at least 24 from the Mini Mental Test,

排除标准

  • presence of psychiatric or severe cognitive dysfunction,
  • pregnancy,
  • Having a neurological disease other than MS,
  • having had an attack in the last 3 months,
  • Botulinum toxin application within the last 6 months,
  • participating in physiotherapy program in the last 6 months

结局指标

主要结局

Change Balance

时间窗: Change from plantar pressure distribution at one month

Romberg test (RT) was performed on the patients with eyes closed and feet together. When the participant held it in one place, the test was terminated, oscillations began, or was likely to fall. Romberg test's maximum duration was 120 sec. RT is clinically used for vestibular problems. Sharpened Romberg (SR) was performed on a straight line with one leg behind the other leg, eyes open, leaving the arms sagging and without impairing the balance. Duration stop criteria were defined as the time that took a participant to dislocate the foot, reach the maximal duration of 30 sec, and contact the observer to avoid falling. Individuals' dynamic balance was evaluated with the Functional Reach Test (FRT). Individuals had requested their hands at 90 degrees by keeping the dominant arms' elbow straight on the wall. The test was performed as reaching forward without taking a step and losing the balance on the wall. The metacarpal bone level was marked in the start position and final position

Change Plantar Pressure Distribution

时间窗: Change from plantar pressure distribution at one month

Pedobarography system was used for plantar pressure analyses. Pedobarography system contains screen, color printer, pressure sensor platform, remote control device, power unit, printer-to-platform and screen-to-platform connections. The maximum and mean pressure in the foot, the percentages of pressure values in the fore and rear of the foot, percentages of the total pressure falling to the foot were evaluated. As higher values mean higher load.

次要结局

  • Change Modified ashworth scale(Change from Modified ashworth scale at one month)

研究者

发起方
Hasan Kalyoncu University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tuba Maden

Principal Investigator, clinical research

Hasan Kalyoncu University

研究点 (1)

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