跳至主要内容
临床试验/NCT04932616
NCT04932616Unknown不适用

Use of the Functional Gait Assessment in Patients With Multiple Sclerosis: Examining Reliability Between Face-to-Face and Online Applications

Istanbul University - Cerrahpasa (IUC)1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年1月26日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
32
试验地点
1
主要终点
Functional Gait Assessment

研究概览

简要总结

The aim of the study is to examine the reliability of the method by applying the Functional Gait Assessment in patients with Multiple Sclerosis via online video conferencing. For this purpose, walking of each patient to be included in the study; The evaluation results will be compared and the intra-rater reliability will be investigated by evaluating both face-to-face and online video conferencing methods. Since the Functional Gait Assessment is not available in Turkish, the scale will also be validated by adapting it to Turkish within the scope of the study.

详细描述

As with all neurological diseases, it is important to use appropriate outcome measurements in the assessment of balance and gait disorders in patients with Multiple Sclerosis (MS), in order to determine the appropriate program for the patient in physiotherapy and rehabilitation applications, both face-to-face and through telerehabilitation. The scale recommended by a clinical practice guide developed with the support of the American Physiotherapy Association (APTA) and the Academy of Neurological Physiotherapy (ANPT) is the Functional Gait Assessment (FGA). According to this proposal, a Turkish version will be made within the scope of the study so that functional walking evaluation can be used in our country. A 2017 study on functional gait assessment and Multiple Sclerosis investigated the validity and sensitivity to changes in the original English version of the test in multiple sclerosis, and as a result, its validity was found for MS. Functional gait assessment does not have a reliability study for Multiple Sclerosis.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Having a definite diagnosis of MS of any clinical type according to the 2017 Mc Donalds criteria by a neurologist,
  • 18 years and over
  • Expanded Disability Status Scale (EDSS) score of 2,5-6
  • Not having an attack within the last 30 days
  • Voluntarily giving consent to participate in the study
  • Absence of visual and auditory impairment for completion of assessments
  • For Tele-assessment:
  • Having a walking area of at least 3 meters at home to evaluate walking
  • Providing a care provider's supervision to ensure walking safety
  • The patient or the caregiver can use the video conferencing software application from the phone or computer

排除标准

  • Diagnosis of another neurological disease that affects the level of ambulation other than MS
  • Receiving corticosteroid therapy within the last 1 month
  • Limitation in range of motion of the lower extremities, which may affect standing and walking
  • Pain that negatively affects walking in the lower extremity and lumbar area (etc., coxarthrosis, gonarthrosis, sciatica)
  • Inability to stand up from a sitting position (Timed Up & Go Test requirement)

结局指标

主要结局

Functional Gait Assessment

时间窗: change from baseline at 15 day

The Functional Gait Assessment is a test designed to assess balance during various walking tasks. This test is a modification of the Dynamic Gait Index to increase reliability and reduce the ceiling effect. This test, which consists of 10 items, evaluates dynamic balance skills such as walking at normal and different speeds, walking with horizontal and vertical head movements, turning quickly, walking over objects, toe-heel walking, walking backwards, walking with eyes closed, and climbing stairs. Each item is scored between 0-3 points; 0 indicates that he is unable to perform that skill or severe gait or balance disorder is observed while performing that skill, and 3 indicates that he has achieved that skill normally. Points 1 and 2 are scored for each task separately for specific situations. Items are added to score the FGA and the maximum total score is set as 30.

次要结局

  • Timed 25-Foot Walk Test(Baseline)
  • Timed Up and Go Test(Baseline)
  • The Four Square Step Test(Baseline)
  • Berg Balance Test(Baseline)
  • 12-item Multiple Sclerosis Walking Scale(Baseline)

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Perim Zengin

Physiotherapist

Istanbul University - Cerrahpasa (IUC)

研究点 (1)

Loading locations...

相似试验