Investigation of the Effectiveness of Matrix Rhythm Therapy in Restless Legs Syndrome: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- International Restless Legs Syndrome Rating Scale
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessor who performed baseline and post-treatment outcome evaluations was blinded to group assignment.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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 -
排除标准
- •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
研究组 & 干预措施
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).
干预措施: MATRİX RHYTHM THERAPY (Device)
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).
干预措施: HOME EXERCISE PROGRAM (Behavioral)
Home Exercise Alone
Participants received a structured home exercise program for 5 weeks.
干预措施: HOME EXERCISE PROGRAM (Behavioral)
结局指标
主要结局
International Restless Legs Syndrome Rating Scale
时间窗: Baseline and 6 weeks
Change in Restless Legs Syndrome severity assessed using the International Restless Legs Syndrome Rating Scale
次要结局
未报告次要终点