Investigation of the Effects of Pilates Training Combined with Whole Body Vibration on Balance and Mobility in Individuals with Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- The Activities-specific Balance Confidence Scale
研究概览
简要总结
The aim of this study is to investigate the effects of Pilates training combined with whole-body vibration (WBV) on balance and mobility in individuals with Multiple Sclerosis (MS). The main questions it aims to answer are:
- Are the improvements in core stability, lower limb functional muscle strength, balance and mobility obtained with Pilates training combined with WBV (Pilates-WBV) in individuals with MS greater than with Pilates training alone?
- Are the improvements in upper extremity performance and fatigue obtained with Pilates-WBV training in individuals with MS greater than with Pilates training alone?
Researchers will compare Pilates-WBV training with a group that received Pilates training alone to see if there is any additional benefit.
Participants will:
- Take Pilates-WBV or Pilates training twice a week for 6 weeks
- Be evaluated with pre- and post-training
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Definitive Multiple Sclerosis diagnosed by a specialist
- •Expanded Disability Status Scale (EDSS) score between 0-5
- •Accepting participation in the study voluntarily
排除标准
- •An MS attack within the last three months
- •Pregnancy
- •Endoprosthesis or electronic implant
- •A cardiovascular, pulmonary or orthopedic disease
- •A disease that can affect the immune system, such as infection or cancer
- •Additional neurological disease
研究组 & 干预措施
Pilates-WBV
17 participants received Pilates and WBV training twice a week for 6 weeks. In each training session, the participants rested for 10 minutes between Pilates and WBV training.
干预措施: Pilates (Other)
Pilates-WBV
17 participants received Pilates and WBV training twice a week for 6 weeks. In each training session, the participants rested for 10 minutes between Pilates and WBV training.
干预措施: Whole Body Vibration (Other)
Pilates
17 participants received Pilates training twice a week for 6 weeks
干预措施: Pilates (Other)
结局指标
主要结局
The Activities-specific Balance Confidence Scale
时间窗: From enrollment to the end of treatment at 6 weeks
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 Five Times Sit-to-Stand Test
时间窗: From enrollment to the end of treatment at 6 weeks
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.
The Timed Up and Go Test
时间窗: From enrollment to the end of treatment at 6 weeks
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 6-Minute Walk Test
时间窗: From enrollment to the end of treatment at 6 weeks
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 Limits of Stability Test
时间窗: From enrollment to the end of treatment at 6 weeks
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 Postural Stability Test
时间窗: From enrollment to the end of treatment at 6 weeks
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 Modified Sensory Organization Test
时间窗: From enrollment to the end of treatment at 6 weeks
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 Side-bridge Test
时间窗: From enrollment to the end of treatment at 6 weeks
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 Biering-Sorensen Test
时间窗: From enrollment to the end of treatment at 6 weeks
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 Trunk Flexor Test
时间窗: From enrollment to the end of treatment at 6 weeks
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 Prone Bridge Test
时间窗: From enrollment to the end of treatment at 6 weeks
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 Sit-ups Test
时间窗: From enrollment to the end of treatment at 6 weeks
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: From enrollment to the end of treatment at 6 weeks
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.
次要结局
- The Nine-Hole Peg Test(From enrollment to the end of treatment at 6 weeks)
- The Fatigue Severity Scale(From enrollment to the end of treatment at 6 weeks)
- The Fatigue Impact Scale(From enrollment to the end of treatment at 6 weeks)
研究者
Arzu Güçlü Gündüz
Profesor Doctor
Gazi University
