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
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Denizli
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Denizli, Denizli, Turcja (Türkiye), 20070
- Pamukkale University Faculty of Physical Therapy and Rehabilitation
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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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Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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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Aktywny komparator: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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International Restless Legs Syndrome Rating Scale
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2020SABE008 (Inny numer grantu/finansowania: Pamukkale University Scientific Research Projects Coordination Unit)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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