Effectiveness of Matrix Rhythm Therapy for Restless Legs Syndrome (MRT-RLS)
Investigation of the Effectiveness of Matrix Rhythm Therapy in Restless Legs Syndrome: A Randomized Controlled Study
The goal of this clinical trial is to evaluate whether Matrix Rhythm Therapy (MRT), when added to a home exercise program, is effective in reducing symptoms of Restless Legs Syndrome (RLS) in adult women. It will also examine the effects of treatment on sleep quality, daytime sleepiness, depressive symptoms, and quality of life.
The main questions it aims to answer are:
Does Matrix Rhythm Therapy reduce the severity of Restless Legs Syndrome symptoms? Does Matrix Rhythm Therapy improve sleep quality and insomnia symptoms? Does Matrix Rhythm Therapy improve quality of life and emotional well-being?
Researchers compared participants receiving Matrix Rhythm Therapy plus home exercise with participants receiving home exercise alone.
Participants will:
Be randomly assigned to one of two study groups Receive a home exercise program for 5 weeks Receive Matrix Rhythm Therapy sessions twice weekly for 5 weeks if assigned to the intervention group Complete questionnaires and clinical assessments before and after treatment
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Restless Legs Syndrome (RLS) is a common neurological disorder that causes uncomfortable sensations in the legs together with a strong urge to move them. Symptoms usually occur during rest, especially in the evening or at night, and may interfere with falling asleep, maintaining sleep, daytime energy, mood, and overall quality of life.
Although medications are commonly used to treat RLS, some patients experience side effects or prefer non-drug treatment options. For this reason, physical therapy and exercise-based approaches are increasingly being explored. Matrix Rhythm Therapy (MRT) is a treatment method that delivers rhythmic mechanical vibrations to soft tissues and muscles. It is intended to support circulation, tissue relaxation, mobility, and neuromuscular regulation.
The purpose of this randomized controlled study was to determine whether adding Matrix Rhythm Therapy to a home exercise program would provide greater benefit than a home exercise program alone in adults with Restless Legs Syndrome.
Eligible participants diagnosed with idiopathic Restless Legs Syndrome were randomly assigned to one of two groups:
Intervention Group: Matrix Rhythm Therapy in addition to a home exercise program Control Group: Home exercise program alone
Participants in both groups received education about lifestyle habits that may help manage RLS symptoms, including sleep hygiene, daily activity planning, and avoidance of possible triggers. Both groups also performed a structured home exercise program consisting of lower extremity stretching and strengthening exercises.
Participants assigned to the intervention group additionally received Matrix Rhythm Therapy sessions twice weekly for 5 weeks, for a total of 10 treatment sessions. Each session lasted approximately 60 minutes.
Study assessments were completed before treatment and after the 5-week intervention period. The study evaluated:
Severity of Restless Legs Syndrome symptoms Insomnia symptoms Daytime sleepiness Sleep quality Depressive symptoms Health-related quality of life
The results of this study may help determine whether Matrix Rhythm Therapy can be a useful non-pharmacological treatment option for individuals with Restless Legs Syndrome.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Denizli
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Denizli, Denizli, Turkije (Türkiye), 20070
- Pamukkale University Faculty of Physical Therapy and Rehabilitation
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
Female participants aged 18 to 65 years Diagnosis of Restless Legs Syndrome Willingness to participate and provide informed consent Ability to comply with treatment sessions and assessments -
Exclusion Criteria:
Pregnancy Neurological or musculoskeletal disorders affecting lower extremities Severe systemic disease Current participation in another clinical study Inability to complete treatment sessions or assessments Use of medications that could significantly affect Restless Legs Syndrome symptoms
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Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Matrix Rhythm Therapy + Home Exercise
Participants received Matrix Rhythm Therapy in addition to a structured home exercise program.
Matrix Rhythm Therapy was applied twice weekly for 5 weeks (10 sessions total, 60 minutes each session).
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Matrix Rhythm Therapy was applied using a certified vibration device delivering rhythmic mechanical oscillations to the lower extremity muscles.
Treatment sessions were administered according to the study protocol for participants with Restless Legs Syndrome.
Participants in the control group received a home exercise program consisting of stretching and therapeutic exercises for the lower extremities, performed according to the study protocol.
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Actieve vergelijker: Home Exercise Alone
Participants received a structured home exercise program for 5 weeks.
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Participants in the control group received a home exercise program consisting of stretching and therapeutic exercises for the lower extremities, performed according to the study protocol.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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International Restless Legs Syndrome Rating Scale
Tijdsspanne: Baseline and 6 weeks
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Change in Restless Legs Syndrome severity assessed using the International Restless Legs Syndrome Rating Scale
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Baseline and 6 weeks
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2020SABE008 (Ander subsidie-/financieringsnummer: Pamukkale University Scientific Research Projects Coordination Unit)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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