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

Study Overview

• Status: Completed
• Conditions: Restless Legs Syndrome (RLS)
• Intervention / Treatment: Device: MATRİX RHYTHM THERAPY; Behavioral: HOME EXERCISE PROGRAM

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Denizli
    • Denizli, Denizli, Turkey (Türkiye), 20070
      • Pamukkale University Faculty of Physical Therapy and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Device: MATRİX RHYTHM THERAPY; 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.; Behavioral: HOME EXERCISE PROGRAM; 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.
Active Comparator: Home Exercise Alone; Participants received a structured home exercise program for 5 weeks.	Behavioral: HOME EXERCISE PROGRAM; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Restless Legs Syndrome Rating Scale	Change in Restless Legs Syndrome severity assessed using the International Restless Legs Syndrome Rating Scale	Baseline and 6 weeks

Collaborators and Investigators

• Sponsor: Pamukkale University

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2021
• Primary Completion (Actual): June 23, 2022
• Study Completion (Actual): September 21, 2022

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Restless Legs Syndrome, Matrix Rhythm Therapy ,Exercise Therapy ,Sleep Quality,Physical Therapy ,Quality of Life
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Parasomnias; Restless Legs Syndrome
• Other Study ID Numbers: 2020SABE008 (Other Grant/Funding Number: Pamukkale University Scientific Research Projects Coordination Unit)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to participant confidentiality and institutional data protection policies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No