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CompletedNCT05885282

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

Investigation of the Effects of Local Vibration Applied to Different Regions and Spinal Stabilization Exercises on Postural Control in Patients with Ataxic Multiple Sclerosis

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Hacettepe University · Academic / Other
Sex
All
Age
18 Years – 50 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEparaspinal vibrationIn 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.
DEVICEgastrosoleus muscle complex vibrationIn 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.
OTHERControl ExerciseLumbar 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.

Timeline

Start date
2023-07-27
Primary completion
2024-06-01
Completion
2024-08-01
First posted
2023-06-01
Last updated
2024-10-02

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05885282. Inclusion in this directory is not an endorsement.

Investigation of the Effects of Local Vibration Applied to Different Regions and Spinal Stabilization Exercises (NCT05885282) · Clinical Trials Directory