Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07068217

Effect of Metronome-Based Structured Rhythmic Exercise Program on Freezing and Gait Parameters in Parkinson Disease

Background: Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by the loss of dopaminergic neurons in the substantia nigra pars compacta, leading to motor symptoms such as resting tremor, freezing episodes, gait disturbances, rigidity, and bradykinesia. It is estimated that approximately 6.1 million people worldwide live with PD. With disease progression, freezing episodes and gait impairments intensify, significantly limiting independence and increasing both fall risk and mortality. Although a definitive cure is lacking, symptom management relies on pharmacological and non-pharmacological interventions.

In PD patients, adaptability to environmental changes and the ability to process sensory inputs and generate motor responses become impaired. Therefore, sensory re-education using auditory, somatosensory, or visual cues is employed. External cues support motor learning by facilitating initiation and maintenance of movement. By promoting cortical reorganization, these cues can improve gait quality, reduce freezing severity, and enhance participation in daily life.

A commonly used method in this context is Rhythmic Auditory Stimulation (RAS). Administered with metronome beats or music, RAS provides external cues via the auditory system to reorganize gait patterns. In patients experiencing freezing, motor blocks during gait can be overcome through rhythmic stimulation. Numerous studies have reported that RAS improves gait speed, step length, and cadence.

Despite its benefits, there is a paucity of methodologically robust, standardized trials evaluating the effects of RAS on real-world symptoms such as gait disturbances and freezing. Therefore, there is a clear need for structured interventions based on metronome-driven rhythmic cues and clinical trials assessing their impact. Furthermore, investigating feasibility in home settings via telerehabilitation is valuable for enhancing accessibility of such interventions.

Purpose: To assess the effects of a structured rhythmic exercise program using metronome cues on freezing episodes, gait parameters, balance, fall risk, and quality of life in PD patients.

Methods: This randomized controlled trial is planned at Taksim Training and Research Hospital from May 2025 to May 2026. Ethical approval has been granted by Istanbul Medipol University's Non-Interventional Clinical Research Ethics Committee (No. E-10840098-202.3.02-221). Sample size was determined via G*Power analysis: two groups (n=13 each), total n=26. Participants will be randomized using Random.org into the Rhythmic Exercise Group (REG) or the Exercise Group (EG).

Both groups will receive a supervised home-based exercise program, overseen via telerehabilitation. Exercises will be performed 3 times per week for 45-60 minutes each session, over 4 weeks (12 sessions total). Progression to the next week's program will require an 80% success rate; otherwise, the same week's program will be repeated. Online supervision will monitor weekly performance.

REG: The structured exercise program will be conducted with metronome cues tailored to each participant's cadence using the "Google Metronome" app.

EG: Participants will perform the same exercises at their own pace, without rhythmic cues.

At the first visit, the demographic information form containing the demographic information and clinical features of all volunteers will be recorded with the necessary information. Then; The participants' disease severity and disability levels will be assessed with the Unified Parkinson's Disease Rating Scale (UPDRS); Walking parameters such as walking speed, step length, step count, cadence and freezing times during walking will be assessed with the 10-Meter Walk Test (10MYT) using Movemate Version 1; Balance skills will be assessed with the MiniBESTest; Performance, with the Timed Up and Go Test (TUG); Freezing and falls in ADL will be assessed with the Freezing While Walking Scale (WGS) and; Falls, with the International Falls Efficacy Scale (IFES); Quality of life will be assessed with the Parkinson's Disease Quality of Life Questionnaire (PHA-39). The assessment tests will be administered face-to-face at the beginning of the study and at the end of the 4th week, 12-18 hours after taking the medication.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

PARKINSON DISEASE (Disorder) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İstanbul Medipol Üniversitesi

Istanbul, İ̇stanbul, 34815, Turkey (Türkiye)

Location contact

MEDİPOL U İSTANBUL MEDİPOL ÜNİVERSİTESİ

CONTACT

+90 216 444 85 44

MERVE ÖZEL ÇAKIR

PRINCIPAL_INVESTIGATOR

PINAR KAYA SARIBAŞ

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hoehn and Yahr Scale Stage III-IV
  • Mini Mental Test Score > 24
  • Stable medication use for the last month
  • Age range 55-75
  • Able to walk 20 meters independently on level ground
  • Answering Yes to the first question of the New Freezing of Gait Questionnaire
  • Having a caregiver with you during the exercises

Exclusion criteria

  • Neurological and Orthopedic Disorders Other Than PD
  • Medically diagnosed hearing loss
  • Patients requiring assistive devices for ambulation
  • Dementia
  • No internet access via smartphone or computer
  • Patients with deep brain pacemakers
  • Having vascular lower extremity pathologies
  • Not receiving any additional physical therapy during the study period

Treatment and study plan

Exercise

Other

Sample size was determined via G*Power analysis: two groups (n=13 each), total n=26. Participants will be randomized using Random.org into the Rhythmic Exercise Group (REG) or the Exercise Group (EG).

Both groups will receive a supervised home-based exercise program, overseen via telerehabilitation. Exercises will be performed 3 times per week for 45-60 minutes each session, over 4 weeks (12 sessions total). Progression to the next week's program will require an 80% success rate; otherwise, the same week's program will be repeated. Online supervision will monitor weekly performance.

Other names: metronome exercises

Primary outcomes

  1. 10m Walking Test

    Time frame: week 1 (beginning of study) - week 4 (end of the study)

    10-Meter Walk Test (10MWT) One of the tests recommended by the American Physical Therapy Association Neurology Section as an outcome measure in individuals with PD, the 10MWT is a widely used test to assess walking speed in individuals with walking limitations. In the test, participants are asked to walk at a speed of their own choosing for the normal walking test and as quickly and safely as possible for the fast walking test. Three trials of each test are completed with short rest breaks between trials if necessary. The time for each test is recorded, the average value is calculated and converted to m/s. There are studies in the literature showing that the 10MYT is reliable and valid in individuals with PD.

    In our study, 10MYT will be applied with 'Movemate version 1' and the collected data will be analyzed.

  2. Spatial parameters of walking with Movemate Version 1.0

    Time frame: week 1 (beginning of the study) - week 2 (end of the study)

    MoveMate Version 1 In this study, the MoveMate Version 1 (*Interrupt Biomedical and Engineering and Joint Stock Company) device will be used to evaluate the spatial parameters of gait in Parkinson's patients. MoveMate Version 1 is a wearable motion tracking system developed for gait analysis, including an accelerometer and gyroscope sensors with a Bosch - BMI270 model IMU (Inertial Measurement Unit) attached to the ankle.

    The device can analyze the patient's gait patterns by recording the patient's gait in real time and store the data securely via a mobile application via Bluetooth connection.

    As part of the study, a 10-m walking test will be applied to the participants by a physiotherapist, and during this process, accelerometer and gyroscope data will be collected in 3 axes with the MoveMate device. The raw data obtained will be analyzed using specially developed software, and basic gait parameters such as step count, step frequency, step length and walking speed will be calculated

  3. Timed Up and Go Test (TUG)

    Time frame: week 1 (beginning of the study)- week 4 (end of the study)

    A simple, widely used and rapid test for assessing mobility, balance and fall risk. To perform the test, participants must get up from a standard chair, walk comfortably to a location 3 meters away from the ground, turn around and return to the chair, and sit back in the same chair. In our study, all steps of the test will be measured in seconds with a stopwatch. The test will be repeated 3 times and the average of these measurements will be analyzed.

  4. MiniBESTest

    Time frame: week 1 (beginning of the study)- week 4 (end of the study)

    It is one of the clinical tests used in the evaluation of walking and balance. It consists of 4 sub-parameters, namely preparatory movement, reactive postural control, sensory orientation, dynamic walking, and a total of 14 items. It is a test that is evaluated over a total of 28 points, requiring an average of 10-15 minutes. High scores indicate high function.

  5. The Freezing of Walking Scale (FWS)

    Time frame: week 1 (beginning of the study- week 4 (end of the study)

    The Freezing of Walking Scale (FWS) was used to determine and evaluate the subjective perception of Parkinson's patients regarding the severity and effect of the degree of freezing on walking performance. This questionnaire consists of 6 questions, 4 of which evaluate the severity of freezing and 2 of which evaluate walking difficulties in general. It is a 5-point scale from 0 to 4, with a total score between 0 and 24. A higher score means that the person's walking performance is more affected by freezing. The validity and reliability study of the FWS in Turkish has been conducted

Secondary outcomes

  1. The International Falls Efficacy Scale (IAES)

    Time frame: week 1 (beginning of the study)- week 4 (end of the study)

    The International Falls Efficacy Scale (IAES) was developed by modifying the Falls Index Scale, which consists of 10 items developed by Tinetti et al. It has been shown to have high test-retest reliability. It evaluates fear of falling during ADL (house cleaning, going up and down stairs, walking, etc.), possible falls, and functional capacity, and consists of 16 items with four answer options. The total score varies between 16 and 64, with a high score indicating a high fear of falling. It has been shown to be reliable and valid in individuals with PD, its internal consistency and test-retest reliability are high, and Visual Analog Scale-Fear of Falling, its validity is moderate-high. The reliability and validity of the Turkish version has been shown in elderly individuals

  2. Parkinson's Disease Quality of Life Questionnaire (PHA-39)

    Time frame: week 1 (beginning of the study)- week 4 (end of the study)

    Parkinson's Disease Quality of Life Questionnaire (PHA-39) It will be used in the assessment of quality of life. PHA-39 is a self-report questionnaire that uses a 5-point Likert scale to assess quality of life such as severity of symptoms of mobility, activities of daily living, emotional well-being, social support, cognition, and communication. The total score ranges from 0 to 100, with higher scores indicating lower quality of life. The validity and reliability study of the questionnaire in Turkish has been conducted.

  3. Unified Parkinson's Disease Rating Scale

    Time frame: week 1-week 4

    UPDRS is considered the gold standard among clinical scales used in the evaluation of Parkinson's disease because it provides comprehensive information in many aspects. UPDRS consists of 4 sections and this scale evaluates; I-Mental state, behavior and mental state (4 questions), II-Daily living activities (13 questions), III-Motor performance (14 questions), IV-Complications of treatment (motor fluctuations, dyskinesias, autonomic dysfunction). The validity and reliability study of the scale has been conducted in Turkish.

Study contacts

Contact information is provided by the study sponsor or research team.

MERVE ÖZEL ÇAKIR

CONTACT

[email protected]

+90 535 584 47 44

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.