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临床试验/NCT03804047
NCT03804047Unknown不适用

KITAMS: Kinesio Tape and Physical Function in Persons With Multiples Sclerosis

Northern Illinois University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
24
试验地点
2
主要终点
The Short Physical Performance Battery

研究概览

简要总结

Multiple sclerosis (MS) is a disease that causes damage within the central nervous system and results in deficits of body functions. The investigators propose a pilot randomized controlled trial examining the acute effect of kinesio tape application in various body segments on balance, mobility, physical functioning, and pain in persons with MS (pwMS) aged 18 to 55 years old. The investigators will objectively assess balance using a force platform and mobility and physical functioning will be assessed using standardized tests (i.e., Timed Up and Go, Timed 25-foot Walk, 6-minute Step Test, Six Spot Step Test). The trial will recruit 24 pwMS aged 18 to 55 years with mild-to-moderate MS-related disability who will be randomized into intervention (Kinesio Tape) or control conditions (Sham/Inflexible Tape). Participants will complete assessments before and after tape application. This pilot trial will inform future research interventions aiming to use the approach in different situations with pwMS (e.g., exercise).

详细描述

Research Plan

Participants The investigators will recruit and enroll 24 pwMS (12 per group) aged 18-55 years. This sample size is appropriate for pilot trials, and was not based on power analysis. The number of 12 per group is justified based on feasibility, gains in the precision about the mean and variance, and regulatory consideration. Related to gains in the precision, the gains are less pronounced after 12 participants. Recruitment will occur though advertisements in local newspapers (100-mile radius around Illinois campus) and posts on the Greater Illinois chapter of the National Multiple Sclerosis Society (NMSS) website. The investigators will further recruit using our participant's database that includes pwMS 40 years of age and older. The 24 persons will be randomly assigned in equal ratios through concealed allocation into either the intervention (i.e., Kinesio Tape - KTG; n=12) or control (i.e., Sham Tape - STG; n=12) conditions. The inclusion criteria are: clinically definitive diagnosis of MS; age between 18 and 55 years; relapse-free for the past 30 days and; ability to walk with or without assistive device (i.e., cane, but not walker/rollator). Participants further must be willing to complete in-person assessments in a university research setting. The investigators will exclude those who use wheelchair, crutches and walker or who have moderate cognitive impairment based on the modified Telephone Interview for Cognitive Status (i.e., moderate cognitive impairment, ≤ 12 points).

Main Outcomes

Balance. Balance will be objectively measured using a force platform (AccuSway, AMTI, Newton, MA, USA) which will be used to calculate the coordinates of the center of pressure (COP) during the standing test using three orthogonal forces and moments. Signals from the force plate will be sampled at 100HZ. Data analysis will then be performed using specific programs developed in MATLAB (Mathworks, Natick, MA, USA). Four classical time domain posturographic parameters will be calculated from the COP co-ordinates: mean deviation along the anterior-posterior (X) and medio-lateral (Y) axes, mean COP velocity along the anterior-posterior (VCOPX) and medio-lateral (VCOPY) axes. Participants will perform a total of four trials (i.e., two with eyes open and two with eyes closed) where they will be asked to stand on the force plate and maintain balance. The force plate will be set up 1.5 meters away from the wall. In the eyes open condition participants will be asked to focus at a dark disc (5cm in diameter) on the wall at the subject's eye level. Each trial will last one minute and participants will be given two minutes rest between trials. The order of the trial condition (eyes open or closed) will be randomized to prevent any order effect.

The Timed and up and Go test (TUG) will be used as a measure of functional mobility. The primary outcome of the TUG test is the total time (in seconds) taken to complete the test. The test will be set up on the basis of standardized descriptions that have been previously reported. Participants will be instructed to complete the course as safely and quickly as possible by standing up (without the help of hands), walking toward and around a cone/mark on the floor (approx. 10 feet), walking back to the chair, and then sitting down. If needed, participants will be allowed to use assistive devices while performing the task. Participants will be given 2 trials to complete the TUG test, and the average time across the 2 trials will be computed as the final score.

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 (Participant)

盲法说明

Randomization will done using concealed allocation with the use of opaque envelopes. Envelopes will be spread out over a table and participants will choose one to give it to the Physical Therapist (PT). The PT will open the envelope to check the type of tape (without showing or saying it to the participant) to be applied (kinesio or Sham tape). Participants are unaware about tape categorization "treatment" or "placebo" as the tapes are unlabeled.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • clinically definitive diagnosis of MS
  • aged 18 - 50 years
  • relapse-free for the past 30 days and
  • ability to walk with or without an assistive device (i.e., cane, but not walker/rollator).
  • must be willing to complete in-person assessments at a university research setting

排除标准

  • use wheelchair, crutches and walker
  • have moderate cognitive impairment based on the modified Telephone Interview for Cognitive Status (i.e., moderate cognitive impairment, ≤ 12 points).

结局指标

主要结局

The Short Physical Performance Battery

时间窗: 6minutes

represent a recently validity measure of physical function in persons with MS

Six-minute Walking Test

时间窗: 10minutes

a measure of walking endurance

Timed and Up and Go

时间窗: 6minutes

a measure of functional mobility

Timed 25-foot Walk

时间窗: 6minutes

a measure of walking speed

Static Balance Performance

时间窗: 10minutes

Center of Pressure (CoP) related measures collected from force plate

Six-spot Step Test

时间窗: 6minutes

a measure of lower-body coordination

次要结局

未报告次要终点

研究者

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

Emerson Sebastião

Assistant Professor

Northern Illinois University

研究点 (2)

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