跳至主要内容
临床试验/NCT03442049
NCT03442049已完成不适用

Randomized Controlled Trial of Core Stability Training in Patients With Multiple Sclerosis: Biomechanical and Performance Based Analysis of Gait

Hacettepe University0 个研究点目标入组 68 人开始时间: 2015年1月1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
入组人数
68
主要终点
6 Minutes Walk Test

研究概览

简要总结

Gait and mobility are among the functions frequently affected in Multiple Sclerosis (MS) and have a negative impact on quality of life. Strength losses in lower limb muscles, ataxia, sensory problems and fatigue are the most important reasons of walking problems in patients with MS. In addition to loss of strength and tonus problems, especially biomechanical disorders can be seen on foot and this problem affects gatin and balance negatively. The stabilizing muscles, defined as the "core" region and enveloping the body like a corset, are active in the context of postural preparation prior to lower extremity movements and stabilize for the limb movements to be performed. The aim of this study was to investigate the effects of spinal stabilization exercises on walking performance, fatigue, plantar pressure distribution, balance, muscle strength and quality of life in patients with Multiple Sclerosis.

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

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

  • Older than 18 years old
  • EDSS score is between 3-5,5
  • Patients who did not take corticosteroid therapy within three months
  • Patients who get at least 24 points from the Mini Mental Test were included in the study.

排除标准

  • Patients who had an acute MS attack or had an attack within the last three months.
  • An orthopedic or systemic problem that would prevent participation in exercises
  • Patients who were using walking orthoses or walking aids were not included in the study.

研究组 & 干预措施

Study group

Experimental

Spinal stabilization exercises in addition to home exercise program

干预措施: Physiotherapy - Study group (Other)

Control Group

Active Comparator

Home exercise program

干预措施: Physiotherapy - control group (Other)

结局指标

主要结局

6 Minutes Walk Test

时间窗: Change from Baseline 6 Minutes Walking Distance at 6 weeks.

Maximum Walking Distance in 6 Minutes

Modified Borg Scale

时间窗: Change from Baseline Fatigue Score at 6 weeks.

Evaluating fatigue between the scores of 0 and 10. "0" means no fatigue at all. "10" means maximal fatigue.

Multiple Sclerosis Quality of Life Scale

时间窗: Change from baseline mental and physical quality of life scores at 6 weeks

Quality of life assessment with 54 questions about mental and physical health in daily life activities.

Plantar Pressure Distribution

时间窗: Change from baseline peak pressure and contact area values at 6 weeks

Peak pressure values of 10 subregions under the foot

次要结局

  • MiniBESTest(Change from baseline MiniBESTest scores at 6 weeks)
  • Dynamic Gait Index(Change from baseline Dynamic Gait Index scores at 6 weeks)
  • Muscle strength with hand held dynamometer(Change from baseline muscle strength at 6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Baris Cetin

Research Assisstant

Hacettepe University

相似试验