跳至主要内容
临床试验/NCT06159361
NCT06159361已完成不适用

The Effect of a Targeted Exercise Program on Balance and Postural Responses in Patients With Multiple Sclerosis (MS)

University of Miami2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2023年12月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
2
主要终点
Change in reaction time

研究概览

简要总结

The purpose of this study is to examine the effects of a postural adjustment, targeted training program on balance ability and postural responses anticipatory postural adjustments (APA) and compensatory postural adjustments (CPA) in individuals with MS

详细描述

All participants participated in individual training program aimed at improving balance ability and postural adjustments. The training program and individual activities were based on previously published programs and motor learning principles, and consists of 18, 1-hour training sessions over six weeks (3 sessions/week). Training occurred in person 2 days a week (in person training) and at home (home exercise program) 1 day a week, for a total of 3 sessions per week. The duration of training sessions were 60 minutes per session for a total of 1,140 minutes of training. The exercise room temperature was centrally regulated (23.3 degrees C).

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must be18 to 70 years of age.
  • Medical diagnosis of MS confirmed by a neurologist.
  • Ability to stand independently without any aid for at least 3 minutes.
  • A Patients determined disease steps (PDDS) score of 5 or lower.
  • Normal or corrected-to-normal vision.
  • English or Spanish speaking.

排除标准

  • MS-related exacerbation or medication change in the past two months.
  • Presence of concurrent neurological or orthopedic disorders.
  • Unable to perform the experimental tasks.

结局指标

主要结局

Change in reaction time

时间窗: Baseline, 6 weeks (post intervention)

Measure in seconds

Change in endpoint excursion percentage

时间窗: Baseline, 6 weeks (post intervention)

measure of endpoint excursion in a percentage out of a100

Change in balance ability as measured by the BESTest

时间窗: Baseline, 6 weeks (post intervention)

The Balance Evaluation Systems Test (BESTest) will be used to measure balance ability. Items are scored from 0 (severe impairment) to 3 (no impairment), with a total score of 108. A higher score suggests better balance ability.

Change in movement velocity

时间窗: Baseline, 6 weeks (post intervention)

Measure in degree per second

Change in CPA as measured by microvolts

时间窗: Baseline, 6 weeks (post intervention)

Postural muscles CPA in microvolts

Change in muscle responses latency as measured by MCT

时间窗: Baseline, 6 weeks (post intervention)

The Motor Control test (MCT) measures the subject's ability to generate a motor response latency to a sudden surface translation in a forward and backward direction at three different magnitudes (small, medium, and large). Latency: The time-lapse between the perturbation onset and the subject response for each limb. The latency is reported in milliseconds.

Change in directional control percentage

时间窗: Baseline, 6 weeks (post intervention)

measure of directional control in a percentage out of a100

Change in maximum excursion percentage

时间窗: Baseline, 6 weeks (post intervention)

measure of maximum excursion in a percentage out of a100

Change in postural muscles responses latency as measured by Electromyography (EMG)

时间窗: Baseline, 6 weeks (post intervention)

Postural muscles responses onset latency in seconds

Change in APA as measured by microvolts

时间窗: Baseline, 6 weeks (post intervention)

Postural muscles APA measured in microvolts

次要结局

  • Change in balance confidence as measured by ABC(Baseline, 6 weeks (post intervention))
  • Change in quality of life as measured by the MSQoL-54(Baseline, 6 weeks (post intervention))

研究者

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

James Moore

Associate professor of clinical

University of Miami

研究点 (2)

Loading locations...

相似试验