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Investigation of the Effects of Local Vibration Applied to Different Regions and Spinal Stabilization Exercises

Primary Purpose

Multiple Sclerosis, Ataxia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
paraspinal vibration
gastrosoleus muscle complex vibration
Control Exercise
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, ataxia, spinal stabilization, local vibration, postural control

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Being between the ages of 18-50 Having been diagnosed with MS by a neurologist EDSS score between 3-5 EDSS pyramidal system score of 3 or less Not using corticosteroids and/or stopping at least 3 months before starting the study Exclusion Criteria: Having a history of attacks in the last 3 months Having orthopedic or systemic problems Presence of peripheral vestibular complaints Participating in another exercise program in the last 6 months Being mentally affected (Mini-Mental Test Score < 24) Severe spasticity (MAS>3) Refusal to participate in the study

Sites / Locations

  • Hacettepe University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Control Exercise Group

Paraspinal Vibration Group

Gastrosoleus Muscle Complex Vibration Group

Arm Description

Lumbar spinal stabilization exercises will be given. Lumbar spinal stabilization exercises; diaphragmatic breathing, and contraction of the transversus abdominis and multifidus muscles will be taught in the supine position. Activation of these muscles will be studied in different positions (prone, crawling, sitting, and sitting on different surfaces). The focus will be on increasing kinesthetic awareness. It will be desirable to ensure and maintain the activation of these muscles during subsequent exercises. Exercises will be continued according to the patient's functional status and individual needs. Advancement of exercises; extremity movements on dynamic surfaces, narrowing of support surfaces, reciprocal movements, increasing the number of resistance and repetitions. The duration of a session will be 40 minutes.

In addition to lumbar spinal stabilization exercises, LV will be applied to the cervical and lumbar paraspinal muscles. Spinal stabilization exercises will be as in the control group. The duration of a session will be 50 minutes, with spinal stabilization exercises 40 minutes and LV 10 minutes.LV will be applied before the exercises. LV will be applied to the cervical paraspinal muscles for a total of 5 minutes (2.5 minutes on the right side, 2.5 minutes on the left side) while the patients are in a sitting position. LV will be applied to the lumbar paraspinal muscles for a total of 5 minutes (2.5 minutes on the right side, 2.5 minutes on the left side) while the patients are lying in the prone position. LV application will be made with Vibrasens © device and vibration frequency 80 Hz amplitude 1 mm will be selected.

In addition to lumbar spinal stabilization exercises, LV will be applied to the gastrosoleus muscle complex. Spinal stabilization exercises will be as in the other 2 groups. The duration of a session will be 50 minutes, with spinal stabilization exercises 40 minutes and LV 10 minutes.LV application will be applied sequentially, bilaterally, to the gastrosoleus complex. LV will be applied before the exercises. LV will be applied for a total of 10 minutes (5 minutes each on the right and left) while the patients are lying in the prone position. LV application will be made with Vibrasens © device and vibration frequency 80 Hz amplitude 1 mm will be selected.

Outcomes

Primary Outcome Measures

Expanded Disability Status Scale
Being between Expanded Disability Status Scale 3-5 and having a pyramidal system score below 3 are among the inclusion criteria. At the beginning of the study, all patients will be evaluated for Expanded Disability Status Scale, and patients who do not meet the criteria will not be included in the study.An increase in the score indicates an increase in the severity of the disease.
International Cooperative Ataxia Rating Scale
It will be used to evaluate the severity of ataxia. International Cooperative Ataxia Rating Scale consists of 4 sub-titles: posture and gait disorders, kinetic functions, speech disorders and oculomotor disorders. The score range is in the range of 0-100, with an increase in the score indicating increased disease severity.
Berg Balance Scale
BBS is a scale that evaluates performance-based balance and scores the performance of 14 different tasks from 0 (not applicable) to 4 (normal performance). In this scale, which is evaluated over 56 points; scores between 0-20 indicate balance disorder, between 21-40 the balance is acceptable, and scores between 41-56 indicate good balance.
Trunk Impairment Scale
The Trunk Impairment Scale, which will be used to evaluate trunk control, has a total of 17 items, of which 3 are static balance, 10 are dynamic balance, and 4 are the coordination ability of the stabilizer muscles. The total score of 0-23 points is recorded. A high score indicates good trunk control.
Limits of Stability and Postural Sways
It will be evaluated with Neurocom Balance Master Static Posturography. During the test, the patient is asked to stand on the platform without shoes and socks. The upper extremities are asked to be on the side of the trunk without support and to look forward. Limits of stability are evaluated with eyes open on a firm surface. While the feet are on the force platform, the foot contact is maintained and the person is asked to go in 8 directions (forward, right-forward, right, right-back, back, left-back, left, left-forward) without losing balance. The test is finished when all directions are completed. Postural sway is evaluated in 4 situations; eyes open-firm surface, eyes closed-firm surface, eyes open-foam surface, eyes closed-foam surface. The person is asked to be as stable as possible.
Gait Analysis
OptoGait Gait Device (Microgate, Bolzano, Italy).Timing, size, and distance are detected and time-distance characteristics are calculated automatically when patients pass between 2 bars positioned on either side of the treadmill. During the test, the patient is asked to get on the treadmill. Then the patient is asked to adjust the speed of the treadmill according to himself (at the speed he feels comfortable) and walk for 1 minute. When the patient walks on the treadmill, objective data about the time-distance characteristics of his gait are obtained. Gait velocity will be recorded in meters/second. Cadence will be recorded in steps/minute.The stride length will be recorded in centimeters.The stance phase and swing phase will be recorded in percent (%).
Prone Bridge Test
Test will be used to evaluate the endurance of lumbopelvic muscles.The patients placed elbows and forearms below their shoulders, straightened the legs. Next, they kept their forearms and toes on the floor, lifted hips, and maintained this straight position as long as possible.
Lateral Bridge Test
Test will be used to evaluate the endurance of lumbopelvic muscles. The patients lay on their left / right sides with support from the forearm with elbows below the shoulders and extended their legs straight. Then the patients lifted their hip from the floor. The test was terminated when the side bridge position deteriorated or the hip fell.
Sorensen Test (Trunk Extensor Test)
Test will be used to evaluate the endurance of lumbopelvic muscles. The patients lied down on a treatment table, aligning their anterior superior iliac spine with the edge of the table, which allowed the upper body to be planked out over the edge. An assessor fixed the patients' pelvis, hip, and knees to the treatment table. The body and the upper extremities were supported using a chair. Next, the chair was removed, and the patients maintained the horizontal body position as long as possible with their arms crossed position on the chest.
Trunk Flexors Test
Test will be used to evaluate the endurance of lumbopelvic muscles. The patients were in a sit-up position while their trunks were supported at the angle of 60 degrees from the floor. They flexed knees and hips at 90 degrees and crossed arms over the chest. Then, the support of the trunk was removed, and the patients maintained this position as long as possible.

Secondary Outcome Measures

Full Information

First Posted
May 10, 2023
Last Updated
July 27, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05885282
Brief Title
Investigation of the Effects of Local Vibration Applied to Different Regions and Spinal Stabilization Exercises
Official Title
Investigation of the Effects of Local Vibration Applied to Different Regions and Spinal Stabilization Exercises on Postural Control in Patients With Ataxic Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 27, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this study is to investigate the effects of local vibration application applied to different regions on postural control in addition to spinal stabilization training in ataxic multiple sclerosis (MS) patients. The study was planned as a single-blind, randomized controlled trial. The patients included in the study will be divided into 3 groups by the closed-envelope randomization method. Each treatment will be 8 weeks, 3 days a week. The control group will be given 40 minutes of lumbar spinal stabilization exercises. Paraspinal vibration group; In addition to 40 minutes of lumbar spinal stabilization exercises, LV will be applied to the paraspinal muscles for 10 minutes. LV application will be applied to the cervical paraspinal muscles for 5 minutes and to the lumbar paraspinal muscles for 5 minutes, bilaterally, sequentially. Gastrosoleus vibration group; In addition to 40 minutes of lumbar spinal stabilization exercises, LV will be applied to the gastrosoleus muscle complex for 10 minutes. LV application will be applied bilaterally, sequentially (5 minutes on the right and left). Assessments will be made by a blind assessor. In assessments; demographic information, Expanded Disability Status Scale (EDSS) /Extended Disability Status Scale (disease stage), International Cooperative Ataxia Rating Scale (ataxia severity), Berg Balance Scale (performance-based balance), Trunk Impairment Scale (trunk control), Neurocom Balance Master Static Posturography (limits of stability and postural sway), OptoGait (gait analysis), lumbopelvic muscle endurance tests will be used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Ataxia
Keywords
Multiple Sclerosis, ataxia, spinal stabilization, local vibration, postural control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Exercise Group
Arm Type
Active Comparator
Arm Description
Lumbar spinal stabilization exercises will be given. Lumbar spinal stabilization exercises; diaphragmatic breathing, and contraction of the transversus abdominis and multifidus muscles will be taught in the supine position. Activation of these muscles will be studied in different positions (prone, crawling, sitting, and sitting on different surfaces). The focus will be on increasing kinesthetic awareness. It will be desirable to ensure and maintain the activation of these muscles during subsequent exercises. Exercises will be continued according to the patient's functional status and individual needs. Advancement of exercises; extremity movements on dynamic surfaces, narrowing of support surfaces, reciprocal movements, increasing the number of resistance and repetitions. The duration of a session will be 40 minutes.
Arm Title
Paraspinal Vibration Group
Arm Type
Active Comparator
Arm Description
In addition to lumbar spinal stabilization exercises, LV will be applied to the cervical and lumbar paraspinal muscles. Spinal stabilization exercises will be as in the control group. The duration of a session will be 50 minutes, with spinal stabilization exercises 40 minutes and LV 10 minutes.LV will be applied before the exercises. LV will be applied to the cervical paraspinal muscles for a total of 5 minutes (2.5 minutes on the right side, 2.5 minutes on the left side) while the patients are in a sitting position. LV will be applied to the lumbar paraspinal muscles for a total of 5 minutes (2.5 minutes on the right side, 2.5 minutes on the left side) while the patients are lying in the prone position. LV application will be made with Vibrasens © device and vibration frequency 80 Hz amplitude 1 mm will be selected.
Arm Title
Gastrosoleus Muscle Complex Vibration Group
Arm Type
Active Comparator
Arm Description
In addition to lumbar spinal stabilization exercises, LV will be applied to the gastrosoleus muscle complex. Spinal stabilization exercises will be as in the other 2 groups. The duration of a session will be 50 minutes, with spinal stabilization exercises 40 minutes and LV 10 minutes.LV application will be applied sequentially, bilaterally, to the gastrosoleus complex. LV will be applied before the exercises. LV will be applied for a total of 10 minutes (5 minutes each on the right and left) while the patients are lying in the prone position. LV application will be made with Vibrasens © device and vibration frequency 80 Hz amplitude 1 mm will be selected.
Intervention Type
Device
Intervention Name(s)
paraspinal vibration
Intervention Description
In addition to lumbar spinal stabilization exercises, LV will be applied to the cervical and lumbar paraspinal muscles. Spinal stabilization exercises will be as in the control group. The duration of a session will be 50 minutes, with spinal stabilization exercises 40 minutes and LV 10 minutes.LV will be applied before the exercises. LV will be applied to the cervical paraspinal muscles for a total of 5 minutes (2.5 minutes on the right side, 2.5 minutes on the left side) while the patients are in a sitting position. LV will be applied to the lumbar paraspinal muscles for a total of 5 minutes (2.5 minutes on the right side, 2.5 minutes on the left side) while the patients are lying in the prone position. LV application will be made with Vibrasens © device and vibration frequency 80 Hz amplitude 1 mm will be selected.
Intervention Type
Device
Intervention Name(s)
gastrosoleus muscle complex vibration
Intervention Description
In addition to lumbar spinal stabilization exercises, LV will be applied to the gastrosoleus muscle complex. LV application will be applied sequentially, bilaterally, to the gastrosoleus complex. LV will be applied before the exercises. LV will be applied for a total of 10 minutes (5 minutes each on the right and left) while the patients are lying in the prone position. LV application will be made with Vibrasens © device and vibration frequency 80 Hz amplitude 1 mm will be selected.
Intervention Type
Other
Intervention Name(s)
Control Exercise
Intervention Description
Lumbar spinal stabilization exerciseswill be given. Lumbar spinal stabilization exercises; Diaphragmatic breathing, and contraction of the transversus abdominis and multifidus muscles will be taught in the supine position. Activation of these muscles will be studied in different positions (prone, crawling, sitting, and sitting on different surfaces). The focus will be on increasing kinesthetic awareness. It will be desirable to ensure and maintain the activation of these muscles during subsequent exercises. Exercises will be continued according to the patient's functional status and individual needs. Advancement of exercises; extremity movements on dynamic surfaces, narrowing of support surfaces, reciprocal movements, increasing the number of resistance and repetitions. The duration of a session will be 40 minutes.
Primary Outcome Measure Information:
Title
Expanded Disability Status Scale
Description
Being between Expanded Disability Status Scale 3-5 and having a pyramidal system score below 3 are among the inclusion criteria. At the beginning of the study, all patients will be evaluated for Expanded Disability Status Scale, and patients who do not meet the criteria will not be included in the study.An increase in the score indicates an increase in the severity of the disease.
Time Frame
Assessment will be done before treatment starts ( on average 15 minutes takes).
Title
International Cooperative Ataxia Rating Scale
Description
It will be used to evaluate the severity of ataxia. International Cooperative Ataxia Rating Scale consists of 4 sub-titles: posture and gait disorders, kinetic functions, speech disorders and oculomotor disorders. The score range is in the range of 0-100, with an increase in the score indicating increased disease severity.
Time Frame
Change from International Cooperative Ataxia Rating Scale at 8 weeks (each assessment on average 20 minutes takes).
Title
Berg Balance Scale
Description
BBS is a scale that evaluates performance-based balance and scores the performance of 14 different tasks from 0 (not applicable) to 4 (normal performance). In this scale, which is evaluated over 56 points; scores between 0-20 indicate balance disorder, between 21-40 the balance is acceptable, and scores between 41-56 indicate good balance.
Time Frame
Change from Berg Balance Scale at 8 weeks (each assessment on average 20 minutes takes).
Title
Trunk Impairment Scale
Description
The Trunk Impairment Scale, which will be used to evaluate trunk control, has a total of 17 items, of which 3 are static balance, 10 are dynamic balance, and 4 are the coordination ability of the stabilizer muscles. The total score of 0-23 points is recorded. A high score indicates good trunk control.
Time Frame
Change from Trunk Impairment Scale at 8 weeks (each assessment on average 10 minutes takes).
Title
Limits of Stability and Postural Sways
Description
It will be evaluated with Neurocom Balance Master Static Posturography. During the test, the patient is asked to stand on the platform without shoes and socks. The upper extremities are asked to be on the side of the trunk without support and to look forward. Limits of stability are evaluated with eyes open on a firm surface. While the feet are on the force platform, the foot contact is maintained and the person is asked to go in 8 directions (forward, right-forward, right, right-back, back, left-back, left, left-forward) without losing balance. The test is finished when all directions are completed. Postural sway is evaluated in 4 situations; eyes open-firm surface, eyes closed-firm surface, eyes open-foam surface, eyes closed-foam surface. The person is asked to be as stable as possible.
Time Frame
Change from limits of stability and postural sways at 8 weeks (each assessment on average 15 minutesutes takes).
Title
Gait Analysis
Description
OptoGait Gait Device (Microgate, Bolzano, Italy).Timing, size, and distance are detected and time-distance characteristics are calculated automatically when patients pass between 2 bars positioned on either side of the treadmill. During the test, the patient is asked to get on the treadmill. Then the patient is asked to adjust the speed of the treadmill according to himself (at the speed he feels comfortable) and walk for 1 minute. When the patient walks on the treadmill, objective data about the time-distance characteristics of his gait are obtained. Gait velocity will be recorded in meters/second. Cadence will be recorded in steps/minute.The stride length will be recorded in centimeters.The stance phase and swing phase will be recorded in percent (%).
Time Frame
Change from gait 8 weeks (each assessment on average 5 minutes takes).
Title
Prone Bridge Test
Description
Test will be used to evaluate the endurance of lumbopelvic muscles.The patients placed elbows and forearms below their shoulders, straightened the legs. Next, they kept their forearms and toes on the floor, lifted hips, and maintained this straight position as long as possible.
Time Frame
Change from lumbopelvic muscle endurance at 8 weeks . In the test, how many seconds they stop is tested.
Title
Lateral Bridge Test
Description
Test will be used to evaluate the endurance of lumbopelvic muscles. The patients lay on their left / right sides with support from the forearm with elbows below the shoulders and extended their legs straight. Then the patients lifted their hip from the floor. The test was terminated when the side bridge position deteriorated or the hip fell.
Time Frame
Change from lumbopelvic muscle endurance at 8 weeks . In the test, how many seconds they stop is tested.
Title
Sorensen Test (Trunk Extensor Test)
Description
Test will be used to evaluate the endurance of lumbopelvic muscles. The patients lied down on a treatment table, aligning their anterior superior iliac spine with the edge of the table, which allowed the upper body to be planked out over the edge. An assessor fixed the patients' pelvis, hip, and knees to the treatment table. The body and the upper extremities were supported using a chair. Next, the chair was removed, and the patients maintained the horizontal body position as long as possible with their arms crossed position on the chest.
Time Frame
Change from lumbopelvic muscle endurance at 8 weeks . In the test, how many seconds they stop is tested.
Title
Trunk Flexors Test
Description
Test will be used to evaluate the endurance of lumbopelvic muscles. The patients were in a sit-up position while their trunks were supported at the angle of 60 degrees from the floor. They flexed knees and hips at 90 degrees and crossed arms over the chest. Then, the support of the trunk was removed, and the patients maintained this position as long as possible.
Time Frame
Change from lumbopelvic muscle endurance at 8 weeks . In the test, how many seconds they stop is tested.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being between the ages of 18-50 Having been diagnosed with MS by a neurologist EDSS score between 3-5 EDSS pyramidal system score of 3 or less Not using corticosteroids and/or stopping at least 3 months before starting the study Exclusion Criteria: Having a history of attacks in the last 3 months Having orthopedic or systemic problems Presence of peripheral vestibular complaints Participating in another exercise program in the last 6 months Being mentally affected (Mini-Mental Test Score < 24) Severe spasticity (MAS>3) Refusal to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammed Kılınç
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
Facility Information:
Facility Name
Hacettepe University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Investigation of the Effects of Local Vibration Applied to Different Regions and Spinal Stabilization Exercises

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