Investigation of the Effects of Local Vibration Applied to Different Regions and Spinal Stabilization Exercises
NCT ID: NCT05885282
Last Updated: 2024-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
30 participants
INTERVENTIONAL
2023-07-27
2024-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effects of Vestibular Exercise and Cervical Stabilization Exercise Training on Balance and Gait in MS Patients
NCT05409599
Local Vibration in Multiple Sclerosis Patients
NCT04192786
The Effects Of Whole Body Vibration On Postural Control In Patients With Ataxia
NCT02977377
Investigation of Acute Effects of Local Vibration and Whole-Body Vibration Applications
NCT04183647
Investigation of the Effects of Pilates Training Combined with Whole Body Vibration on Balance and Mobility in Individuals with Multiple Sclerosis
NCT06829680
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control Exercise Group
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.
Control Exercise
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.
Paraspinal Vibration Group
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.
paraspinal vibration
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.
Gastrosoleus Muscle Complex Vibration Group
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.
gastrosoleus muscle complex vibration
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
paraspinal vibration
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.
gastrosoleus muscle complex vibration
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.
Control Exercise
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hacettepe University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Güngör Beyza ÖZVAR
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Muhammed Kılınç
Role: STUDY_DIRECTOR
Hacettepe University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hacettepe University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation
Ankara, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Local Vibration Application
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.