Clinical trial NCT05885282: 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
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Ataxia
Keywords: Multiple Sclerosis
ataxia
spinal stabilization
local vibration
postural control
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Expanded Disability Status Scale
timeFrame: Assessment will be done before treatment starts ( on average 15 minutes takes).
measure: International Cooperative Ataxia Rating Scale
timeFrame: Change from International Cooperative Ataxia Rating Scale at 8 weeks (each assessment on average 20 minutes takes).
measure: Berg Balance Scale
timeFrame: Change from Berg Balance Scale at 8 weeks (each assessment on average 20 minutes takes).
measure: Trunk Impairment Scale
timeFrame: Change from Trunk Impairment Scale at 8 weeks (each assessment on average 10 minutes takes).
measure: Limits of Stability and Postural Sways
timeFrame: Change from limits of stability and postural sways at 8 weeks (each assessment on average 15 minutesutes takes).
measure: Gait Analysis
timeFrame: Change from gait 8 weeks (each assessment on average 5 minutes takes).
measure: Prone Bridge Test
timeFrame: Change from lumbopelvic muscle endurance at 8 weeks . In the test, how many seconds they stop is tested.
measure: Lateral Bridge Test
timeFrame: Change from lumbopelvic muscle endurance at 8 weeks . In the test, how many seconds they stop is tested.
measure: Sorensen Test (Trunk Extensor Test)
timeFrame: Change from lumbopelvic muscle endurance at 8 weeks . In the test, how many seconds they stop is tested.
measure: Trunk Flexors Test
timeFrame: Change from lumbopelvic muscle endurance at 8 weeks . In the test, how many seconds they stop is tested.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation
Study officials:
affiliation: Hacettepe University
name: Muhammed Kılınç
role: STUDY_DIRECTOR
References: