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临床试验/NCT07370935
NCT07370935尚未招募不适用

The Relationship Between Trunk Stability, Balance, Mobility, Upper Limb Performance, and Fatigue in Minimally to Moderately Disabled People With Multiple Sclerosis

Cappadocia University0 个研究点目标入组 64 人开始时间: 2026年1月26日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
64
主要终点
The Prone Bridge Test

研究概览

简要总结

The goal of this observational study is to investigate the relationship between trunk stability and balance, mobility, upper limb performance, and fatigue in people with multiple sclerosis (MS) with minimal to moderate disability levels.

The main questions it aims to answer are:

  1. Is trunk stability associated with balance, mobility, upper limb performance, and fatigue in people with multiple sclerosis with minimal to moderate disability?
  2. Do balance, mobility, upper limb performance, and fatigue differ between minimally and moderately disabled people with multiple sclerosis?

Participants with a diagnosis of multiple sclerosis and Expanded Disability Status Scale (EDSS) scores ≤2 (minimally disabled) and 2.5-4 (moderately disabled) will be included in the study.

Participants will undergo standardized clinical assessments to evaluate trunk stability, balance, mobility, upper limb performance, and fatigue during a single assessment session. No intervention will be applied as part of the study, and all measurements will reflect participants' current functional status.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

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

  • The diagnosis of multiple sclerosis was confirmed by a neurologist.
  • Expanded Disability Status Scale (EDSS) score between 0 and 4
  • Age between 18 and 65 years
  • Accepting participation in the study voluntarily

排除标准

  • An MS attack within the last three months
  • Pregnancy
  • Presence of cardiovascular, pulmonary, or orthopedic conditions that would prevent participation in exercise
  • A disease that can affect the immune system, such as infection or cancer
  • Additional neurological disease

结局指标

主要结局

The Prone Bridge Test

时间窗: Single assessment at the time of enrollment

The prone bridge test was used to assess core muscle endurance. In this test, the individuals were asked to raise their bodies in a prone position, supporting themselves on their forearms and toes with their elbows flexed, maintaining this position for as long as possible. When the individual was unable to maintain the position, the test was terminated. The score was the total time in seconds to complete the task. In the study, the test was repeated twice, and the longer duration was recorded.

The Side-bridge Test

时间窗: Single assessment at the time of enrollment

The side-bridge test was used to assess core muscle endurance. The individuals were positioned in a straight line, lying on their left or right side with their legs fully extended. The individuals were asked to lift their body on forearms and toes, and maintain this position for as long as possible. When the individual was unable to maintain the position, the test was terminated. The score was the total time in seconds to complete the task. In the study, the test was performed twice, and the longer duration was recorded.

The Trunk Flexor Test

时间窗: Single assessment at the time of enrollment

The trunk flexor test was used to assess core muscle endurance. The individuals were positioned in a sit-up position with their back resting against a wedge angled at 60° from the floor. After the wedge was removed, they were asked to maintain this position for as long as possible. When the individual was unable to maintain the position, the test was terminated. The score was the total time in seconds to complete the task. In the study, the test was repeated twice, and the longer duration was recorded.

The Biering-Sorensen Test

时间窗: Single assessment at the time of enrollment

The Biering-Sorensen test was used to assess core muscle endurance. In this test, the individuals were asked to lie prone on a workout bench, aligning their anterior superior iliac spine with the edge of the bench, allowing the upper body to extend over the edge. An assisting partner secured the individuals' knees, hips, and pelvis. The individuals were instructed to fold their arms across their chest and to hold this position for as long as possible. When the individual was unable to maintain the position, the test was terminated. The score was the total time in seconds to complete the task. In the study, the test was performed twice, and the longer duration was recorded.

The Sit-ups Test

时间窗: Single assessment at the time of enrollment

The sit-ups test was used to assess core muscle strength. The test began when the individuals were instructed to ''go'', and they were asked to lift their upper body off the floor, raising the lower corner of the scapula. The score was recorded as the number of repetitions completed in 30 seconds. In the study, the test was performed twice, and the highest number of repetitions was recorded.

The Modified Push-ups Test

时间窗: Single assessment at the time of enrollment

The modified push-ups test was used to assess core muscle strength. The individuals were positioned on their hands and knees with hands shoulder-width apart and elbows fully extended. They dropped their hips and moved their hands forward until they created a straight line and a straight back from the knees to the hips to the shoulders. During the test, the individuals were asked to maintain this straight position while lowering their upper body until their elbows were bent to 90°, then pushing back up to the starting position. The score was recorded as the number of repetitions completed in 30 seconds. In the study, the test was performed twice, and the highest number of repetitions was recorded.

The Postural Stability Test

时间窗: Single assessment at the time of enrollment

The Postural Stability Test was assessed with The Biodex-Biosway Portable Balance System (Biodex Medical System Inc., Shirley, NY, USA). The test evaluates static balance by assessing the individual's ability to maintain their center of gravity over the support surface while standing. During the test, the individuals were asked to stand as still as possible. The test duration was 30 seconds and a total stability index score was calculated. The stability index scores range from 0 to 4, with lower scores indicating good postural stability.

The Limits of Stability Test

时间窗: Single assessment at the time of enrollment

The Limits of Stability Test was assessed with The Biodex-Biosway Portable Balance System (Biodex Medical System Inc., Shirley, NY, USA). During the test, the individuals were asked to move their bodies toward target points displayed on the screen without lifting their feet and then return to the center point. During this movement, they were instructed to move as quickly and accurately as possible. The test results in a total percentage score. A lower score indicates decreased stability limits.

The Modified Sensory Organization Test

时间窗: Single assessment at the time of enrollment

The Modified Sensory Organization Test (MSOT) was assessed with the Biodex-Biosway Portable Balance System (Biodex Medical System Inc., Shirley, NY, USA). In the test, by selectively disrupting visual and somatosensory inputs, it is determined which sensory inputs the individual relies on the most to maintain postural stability. The MSOT was performed under four conditions in the study: eyes open on a firm surface, eyes closed on a firm surface, eyes open on a soft surface, and eyes closed on a soft surface. The individuals were instructed to maintain their balance in all conditions. The test duration was 30 seconds for each condition. The sway index scores were calculated at the end of the test. The sway index scores range from 0 to 4, with lower sway index scores indicating decreased postural sway.

The Activities-specific Balance Confidence Scale

时间窗: Single assessment at the time of enrollment

The Activities-specific Balance Confidence Scale (ABC) evaluates balance confidence in daily living activities and includes 16 activities related to balance. Participants were asked to rate their perceived safety while performing these activities and their perceived risk of falling on a scale from 0 (completely unsafe) to 100 (completely safe). The total score is calculated by dividing the score by 16 and ranges from 0 to 100. Scores closer to zero indicate greater balance impairment and a higher risk of falls.

The 6-Minute Walk Test

时间窗: Single assessment at the time of enrollment

Walking performance and functional exercise capacity were assessed using the Six-Minute Walk Test (6-MWT). Participants were instructed to walk at the highest speed they felt safe in a 30-meter straight pathway for six minutes. The score was the total walking distance in meters at the end of the test.

The Timed Up and Go Test

时间窗: Single assessment at the time of enrollment

Functional mobility was assessed by the Timed Up and Go Test (TUG). During the test, the individuals were asked to get up from the chair, walk 3 meters, turn around, walk back to the chair, and sit down. The score was the total time in seconds to complete the task. In the study, the test was repeated three times, and the average time was recorded.

The Five Times Sit-to-Stand Test

时间窗: Single assessment at the time of enrollment

Lower extremity functional muscle strength was assessed by the Five Times Sit-to-Stand Test. The individuals were seated in a standard chair with arm support of 43-45 cm height, with their arms crossed on their chests. When the command "Start" was given, individuals were asked to stand up as quickly as possible and sit down and stand up 5 times. The score was the total time in seconds to complete the task. In the study, the test was repeated twice and the shortest time was recorded.

次要结局

  • The Nine-Hole Peg Test(Single assessment at the time of enrollment)
  • The Fatigue Severity Scale(Single assessment at the time of enrollment)
  • The Fatigue Impact Scale(Single assessment at the time of enrollment)

研究者

发起方
Cappadocia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tansu Kus

Assistant Professor

Cappadocia University

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