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
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Denizli
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Denizli, Denizli, Turkki (Türkiye), 20070
- Pamukkale University Faculty of Physical Therapy and Rehabilitation
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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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Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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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Active Comparator: 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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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International Restless Legs Syndrome Rating Scale
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 2020SABE008 (Muu apuraha/rahoitusnumero: Pamukkale University Scientific Research Projects Coordination Unit)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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