Investigation of the Effects of Pilates Training Combined with Whole Body Vibration on Balance and Mobility in Individuals with Multiple Sclerosis

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 65 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Multiple Sclerosis

Being tested

Pilates, Whole Body Vibration

Keywords

Balance, Multiple Sclerosis, Mobility, Pilates, Vibration

Medical subject headings

Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• PilatesOther

  The participants were given a total of 12 sessions of Pilates training, applied twice a week for 6 weeks, and each session lasted approximately 60 minutes. The 60-min session consisted of warm up and cool down (5 min each) and the main active phase (50 min).

  In the main active phase; "One leg stretch", "Double leg stretch", "One leg circle", "Heels together toes apart", "Shoulder bridge", "The hundreds", "Chest lift", "Criss cross", "Clam", "Side bend", "Arm opening", "Cobra", "Breast stroke", "Swimming", "Modified push-up", "Plank", "Leg pull prone" and "Squat" exercises were performed. The exercises were applied with 10 repetitions in the first 3 weeks and with 20 repetitions in the last 3 weeks.

• Whole Body VibrationOther

  The participants were given a total of 12 sessions of WBV training, applied twice a week for 6 weeks.

  The vibration parameters were set as frequency: 20 Hz, amplitude: 2-3 mm, duration: 30-60 s and rest period: 60 s. The application time of the WBV training was 30 s for the first two weeks, 45 s for the next two weeks and 60 s for the last two weeks.

  The individuals were asked to maintain squat, shoulder bridge and quadruped positions statically for the first two weeks. Starting from the third week, they were asked to perform reciprocal upper extremity flexion and extension movements during the positions. The application was repeated 3 times in each position.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. The Activities-specific Balance Confidence Scale

   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.

   Measured: From enrollment to the end of treatment at 6 weeks

2. The Five Times Sit-to-Stand Test

   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.

   Measured: From enrollment to the end of treatment at 6 weeks

3. The Timed Up and Go Test

   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.

   Measured: From enrollment to the end of treatment at 6 weeks

4. The 6-Minute Walk Test

   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.

   Measured: From enrollment to the end of treatment at 6 weeks

5. The Limits of Stability Test

   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.

   Measured: From enrollment to the end of treatment at 6 weeks

6. The Postural Stability Test

   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.

   Measured: From enrollment to the end of treatment at 6 weeks

7. The Modified Sensory Organization Test

   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.

   Measured: From enrollment to the end of treatment at 6 weeks

8. The Side-bridge Test

   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.

   Measured: From enrollment to the end of treatment at 6 weeks

9. The Biering-Sorensen Test

   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.

   Measured: From enrollment to the end of treatment at 6 weeks

10. The Trunk Flexor Test

    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.

    Measured: From enrollment to the end of treatment at 6 weeks

11. The Prone Bridge Test

    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.

    Measured: From enrollment to the end of treatment at 6 weeks

12. The Sit-ups Test

    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.

    Measured: From enrollment to the end of treatment at 6 weeks

13. The Modified Push-ups Test

    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.

    Measured: From enrollment to the end of treatment at 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted17 Feb 2025
2. Study start28 Dec 2023
3. Primary completion22 Aug 2024
4. Study completion21 Sep 2024

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for Multiple SclerosisStudies of the same condition, open and under way.
• More trials run by Gazi UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.