Effectiveness of Matrix Rhythm Therapy for Restless Legs Syndrome

NCT07561476 | Completed

• 1 other identifier: 2020SABE008
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Restless Legs Syndrome (RLS)

Keywords

Restless Legs Syndrome, Matrix Rhythm Therapy ,Exercise Therapy ,Sleep Quality,Physical Therapy ,Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Matrix Rhythm Therapy + Home Exercise

EXPERIMENTAL

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; Behavioral: HOME EXERCISE PROGRAM

Home Exercise Alone

ACTIVE COMPARATOR

Participants received a structured home exercise program for 5 weeks.

Behavioral: HOME EXERCISE PROGRAM

Interventions

MATRİX RHYTHM THERAPY DEVICE

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.

Matrix Rhythm Therapy + Home Exercise

HOME EXERCISE PROGRAM BEHAVIORAL

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.

Home Exercise Alone; Matrix Rhythm Therapy + Home Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Only individuals who self-identified as women were eligible to participate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University Faculty of Physical Therapy and Rehabilitation

Denizli, Denizli, 20070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor who performed baseline and post-treatment outcome evaluations was blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Participants were randomly assigned in parallel to one of two groups: Matrix Rhythm Therapy plus home exercise program, or home exercise program alone.

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start: May 4, 2021
• Primary Completion: June 23, 2022
• Study Completion: September 21, 2022
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)