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临床试验/NCT06981013
NCT06981013招募中不适用

Effects of Balance-based Torso Weighting on Muscle Activation During Balance Tests in Individuals With and Without Multiple Sclerosis

University of St. Augustine for Health Sciences1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年3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
招募中
发起方
入组人数
40
试验地点
1
主要终点
Muscle Activation of B lateral gastrocnemius and tibialis anterior

研究概览

简要总结

Rationale: The Balance-Based Torso-Weighting (BBTW) is a patented evaluation system that uses strategic placement of small or lightweight weights on the trunk to improve balance and stability. BBTW has been found to improve the upright mobility of people with multiple sclerosis, however the mechanism underlying the improvement of balance and gait is still unknown.1-2 Purpose: The purpose of this study is to investigate the immediate effects of BBTW on muscle activation of tibialis anterior and gastrocsoleus and sway using electromyography and force plates during balance tests in people with MS and healthy controls?

详细描述

Research Questions:

Question #1 - Is there a difference in EMG within postural muscles (tibialis anterior and gastrocsoleus) and between healthy and MS when not wearing weighted vest with eyes open? Question #2 - Is there a difference in EMG within postural muscles (tibialis anterior and gastrocsoleus) and between healthy and MS when not wearing weighted vest with eyes closed? Question #3 - Is there a difference in EMG within postural muscles (tibialis anterior and gastrocsoleus) and between healthy and MS when wearing weighted vest eyes open? Question #4 - Is there a difference in EMG within postural muscles (tibialis anterior and gastrocsoleus) and between healthy and MS when wearing weighted vest eyes closed? Question #5 - Is there a difference in SWAY within postural muscles (tibialis anterior and gastrocsoleus) and between healthy and MS when not wearing weighted vest with eyes open? Question #6 - Is there a difference in SWAY within postural muscles (tibialis anterior and gastrocsoleus) and between healthy and MS when not wearing weighted vest with eyes closed? Question #7 - Is there a difference in SWAY within postural muscles (tibialis anterior and gastrocsoleus) and between healthy and MS when wearing weighted vest eyes open? Question #8 - Is there a difference in SWAY within postural muscles (tibialis anterior and gastrocsoleus) and between healthy and MS when wearing weighted vest eyes closed? Research Design: Quasi-experimental design

研究设计

研究类型
Interventional
分配方式
Non 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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •for Individuals with Multiple Sclerosis group:
  • •self-reported diagnosis of multiple sclerosis (MS)
  • •age 18 to 75 years old
  • •able to communicate in English
  • •able to provide informed consent
  • •able to tolerate up to three hours of testing with rest breaks
  • •able to walk 20 meters with or without assistive device and without resting (equivalent to Expanded Disability Status Scale of 6.5 or less).
  • •Inclusion criteria for the Healthy Control group:
  • •able to communicate in English
  • •able to provide informed consent
  • •physical criteria that matched each participant with MS which included age (within 7 years), height (within 12.7 cm [5 in]), mass (within 9.1 kg [20 lb]) and sex.

排除标准

  • •for Individuals with Multiple Sclerosis group:
  • •exacerbation of MS within the past two months
  • •had a diagnosis of a concurrent neurological disorder (head injury, stroke, Parkinson's disease, etc.)
  • •reported pain that could be exacerbated by external perturbations during standing.
  • •Exclusion Criteria for Healthy control group:
  • •Known diagnoses
  • •current pain that could affect balance.

研究组 & 干预措施

Multiple Sclerosis Arm

Experimental

Without and with balance-based torso weighting

干预措施: balance based torso weighting (Other)

Healthy Control Arm

Active Comparator

Without and with balance-based torso weighting

干预措施: balance based torso weighting (Other)

结局指标

主要结局

Muscle Activation of B lateral gastrocnemius and tibialis anterior

时间窗: Baseline and study completion, after an average of three hours

Noraxon EMG will be used to measure muscle activation

Postural Sway as measured by center of pressure displacement

时间窗: Baseline and study completion, after an average of three hours

Kistler Force Plate will be used center of pressure displacement in the x and y axis

次要结局

未报告次要终点

研究者

发起方
University of St. Augustine for Health Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Evan M. Pucillo, PT, DPT, EdD

Director of Research

University of St. Augustine for Health Sciences

研究点 (1)

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