Restless Legs Syndrome (RLS)MRT-RLSNCT07561476
Effectiveness of Matrix Rhythm Therapy for Restless Legs Syndrome
A study testing MATRİX RHYTHM THERAPY and HOME EXERCISE PROGRAM in people with Restless Legs Syndrome (RLS), run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Restless Legs Syndrome (RLS)
- What is being tested?
- MATRİX RHYTHM THERAPY and HOME EXERCISE PROGRAM
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 May 2021to 21 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University Faculty of Physical Therapy and Rehabilitation
Denizli, Denizli, 20070
About this study
Official title: 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:
Read more
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
Read the 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.
- Conditions
- Restless Legs Syndrome (RLS)
- Being tested
- MATRİX RHYTHM THERAPY, HOME EXERCISE PROGRAM
- Keywords
- Restless Legs Syndrome, Matrix Rhythm Therapy ,Exercise Therapy ,Sleep Quality,Physical Therapy ,Quality of Life
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MATRİX RHYTHM THERAPYDevice
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.
HOME EXERCISE PROGRAMBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: MATRİX RHYTHM THERAPY; Behavioral: HOME EXERCISE PROGRAM |
| Home Exercise Alone | Active comparator | Participants received a structured home exercise program for 5 weeks. Receives: Behavioral: HOME EXERCISE PROGRAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Restless Legs Syndrome Rating Scale
Change in Restless Legs Syndrome severity assessed using the International Restless Legs Syndrome Rating Scale
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start4 May 2021
- Primary completion23 Jun 2022
- Study completion21 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs Syndrome (RLS)Studies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in parallel to one of two groups: Matrix Rhythm Therapy plus home exercise program, or home exercise program alone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma TASKIN, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561476
- Sponsor's protocol ID
- 2020SABE008
- Other IDs
- 2020SABE008
- Acronym
- MRT-RLS
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to participant confidentiality and institutional data protection policies.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Matrix Rhythm Therapy in Restless Legs Syndrome: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07561476
- Acronym / sponsor ID
- MRT-RLS / 2020SABE008
- Conditions
- Restless Legs Syndrome (RLS)
- Keywords
- Restless Legs Syndrome, Matrix Rhythm Therapy ,Exercise Therapy ,Sleep Quality,Physical Therapy ,Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 4 May 2021 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in parallel to one of two groups: Matrix Rhythm Therapy plus home exercise program, or home exercise program alone.
| Arm | Type | Receives |
|---|---|---|
| Matrix Rhythm Therapy + Home Exercise | Experimental | Device: MATRİX RHYTHM THERAPY, Behavioral: HOME EXERCISE PROGRAMParticipants 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). |
| Home Exercise Alone | Active comparator | Behavioral: HOME EXERCISE PROGRAMParticipants received a structured home exercise program for 5 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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 -
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MATRİX RHYTHM THERAPYMatrix 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. | Device | Matrix Rhythm Therapy + Home Exercise |
| HOME EXERCISE PROGRAMParticipants 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. | Behavioural | Home Exercise Alone, Matrix Rhythm Therapy + Home Exercise |
Primary outcome
International Restless Legs Syndrome Rating Scale
Time frame: Baseline and 6 weeks
Change in Restless Legs Syndrome severity assessed using the International Restless Legs Syndrome Rating Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to participant confidentiality and institutional data protection policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MATRİX RHYTHM THERAPY and HOME EXERCISE PROGRAM in people with Restless Legs Syndrome (RLS), run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Restless Legs Syndrome Rating Scale (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.