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临床试验/NCT05571631
NCT05571631尚未招募不适用

Investigation of the Effect of the Combination of Arm Ergometer Exercise and Balance Training on Upper Extremity Function in People With Multiple Sclerosis

Dokuz Eylul University0 个研究点目标入组 30 人开始时间: 2022年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
Nine-Hole Peg Test

研究概览

简要总结

This study will investigate the effects of a 12-week arm ergometer exercise and balance training on upper extremity function in persons with multiple sclerosis.

详细描述

Multiple sclerosis (MS) is an inflammatory, demyelinating, neurodegenerative disease of the central nervous system of unknown etiology. The most common clinical signs and symptoms are motor dysfunction, fatigue, spasticity, impaired mobility, cognitive impairment, chronic pain, depression, decreased quality of life, and bladder and bowel dysfunction. 66% of people with MS (pwMS) have impaired upper extremity function.

As a result of the deterioration in upper extremity function, the performance of many daily living activities affects performance. As a result of this influence, there is a decrease in the functional independence of pwMS, quality of life and participation in activities in the community.

Another common symptom that reduces quality of life, independence, and participation in pwMS is balance disorder, seen in 75% of cases. Abnormality in balance control occurs due to lack of postural stability, limitation of stability limits, slowness to return to the starting position during bending and reaching activities. During interaction with the environment in daily life, proprioceptive inputs from the extremities and subsequent proper trunk control enable the person to keep the center of gravity on the support surface at rest and in activity. In this way, proximal stability is provided and tasks that require participation in daily life with distal mobility are performed. It is necessary to manage these progressive symptoms associated with the disease in order to increase the quality of life of pwMS, increase the rate of participation in society and maintain this increase.

Exercise training represents an existing behavioral treatment approach to safely manage many functional, symptomatic and quality-of-life outcomes in MS. Current literature reports that aerobic exercise has a positive effect on important parameters such as balance, fatigue, walking, quality of life, and pain in pwMS. At the same time, aerobic exercise training with arm ergometry allows pwMS to improve their upper extremity function. Apart from these, the literature has separately examined the effects of exercise training on upper extremity function and balance in pwMS, and positive effects have been shared separately. However, the relationship between these two important issues and the effect of exercise training on this relationship have not been examined.

The aim of the study is to examine the effects of exercise training on upper extremity function and balance in pwMS.

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
Single (Outcomes Assessor)

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

  • A relapsing-remitting or secondary progressive type of multiple sclerosis,
  • To be willing to participate in the study.

排除标准

  • Another neurological disorder,
  • Orthopedic surgery history including the elbow, wrist, shoulder, ankle-foot, knee, hip or spine, affecting balance and upper extremity functions,
  • Diagnosed severe cognitive and/or psychiatric impairment,
  • Having congestive heart failure, coronary, cerebrovascular, and pulmonary disease such as COPD
  • Having cardiac disease such as hypertension that would be a contraindication to exercise

结局指标

主要结局

Nine-Hole Peg Test

时间窗: Change from Baseline at 12 weeks

The Nine-Hole Peg Test measures finger dexterity.

次要结局

  • Jamar Hand Dynamometer(Change from Baseline at 12 weeks)
  • Expanded Disability Status Scale(Baseline)
  • Arm Function in Multiple Sclerosis Questionnaire(Change from Baseline at 12 weeks)
  • Modified Fatigue Impact Scale(Change from Baseline at 12 weeks)
  • Preference-based Multiple Sclerosis Index(Change from Baseline at 12 weeks)
  • Estimated VO2 Max(Change from Baseline at 12 weeks)
  • Timed Up and Go test(Change from Baseline at 12 weeks)
  • Activities-Specific Balance Confidence Scale(Change from Baseline at 12 weeks)
  • Coin Rotation Test(Change from Baseline at 12 weeks)

研究者

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

Serkan Ozakbas

Prof. Dr.

Dokuz Eylul University

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