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

H

Hacettepe University

Status

Completed

Conditions

Multiple Sclerosis
Ataxia

Treatments

Device: gastrosoleus muscle complex vibration
Device: paraspinal vibration
Other: Control Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT05885282
Local Vibration Application

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 3 patient groups

Control Exercise Group
Active Comparator group
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.
Treatment:
Other: Control Exercise
Paraspinal Vibration Group
Active Comparator group
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.
Treatment:
Device: paraspinal vibration
Gastrosoleus Muscle Complex Vibration Group
Active Comparator group
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.
Treatment:
Device: gastrosoleus muscle complex vibration

Trial contacts and locations

1

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Central trial contact

Beyza Özvar, MSc

Data sourced from clinicaltrials.gov

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