PARKINSON DISEASE (Disorder)NCT07068217
Effect of Metronome-Based Structured Rhythmic Exercise Program on Freezing and Gait Parameters in Parkinson Disease
A study testing Exercise in people with PARKINSON DISEASE (Disorder), run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
İstanbul Medipol Üniversitesi
Istanbul, İ̇stanbul, 34815
MEDİPOL U İSTANBUL MEDİPOL ÜNİVERSİTESİ, +90 216 444 85 44
MERVE ÖZEL ÇAKIR
About this study
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.
Read more
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.
- Conditions
- PARKINSON DISEASE (Disorder)
- Being tested
- Exercise
- Keywords
- Parkinson disease, cueing, freezing of gait
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called metronome exercises
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.
| Study group | Role | What they receive |
|---|---|---|
| REG | Experimental | Rhythmic Exercise Group: The structured exercise program will be conducted with metronome cues tailored to each participant's cadence using the "Google Metronome" app.
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. Receives: Other: Exercise |
| EG | Active comparator | Exercise Group: Participants will perform the same exercises at their own pace, without rhythmic cues. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
10m Walking Test
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.
Measured: week 1 (beginning of study) - week 4 (end of the study)
Spatial parameters of walking with Movemate Version 1.0
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
Measured: week 1 (beginning of the study) - week 2 (end of the study)
Timed Up and Go Test (TUG)
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.
Measured: week 1 (beginning of the study)- week 4 (end of the study)
MiniBESTest
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.
Measured: week 1 (beginning of the study)- week 4 (end of the study)
The Freezing of Walking Scale (FWS)
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
Measured: week 1 (beginning of the study- week 4 (end of the study)
Secondary outcomes (3)
The International Falls Efficacy Scale (IAES)
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
Measured: week 1 (beginning of the study)- week 4 (end of the study)
Parkinson's Disease Quality of Life Questionnaire (PHA-39)
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.
Measured: week 1 (beginning of the study)- week 4 (end of the study)
Unified Parkinson's Disease Rating Scale
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.
Measured: week 1-week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- More trials run by Medipol 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, merve özel, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068217
- Sponsor's protocol ID
- E-10840098-202.3.02-221
- Status last verified
- Jul 2025
- First submitted
- 6 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Ulus Y, Durmus D, Akyol Y, Terzi Y, Bilgici A, Kuru O. Reliability and validity of the Turkish version of the Falls Efficacy Scale International (FES-I) in community-dwelling older persons. Arch Gerontol Geriatr. 2012 May-Jun;54(3):429-33. doi: 10.1016/j.archger.2011.06.010. Epub 2011 Aug 9.
PubMed 21831462Yardley L, Beyer N, Hauer K, Kempen G, Piot-Ziegler C, Todd C. Development and initial validation of the Falls Efficacy Scale-International (FES-I). Age Ageing. 2005 Nov;34(6):614-9. doi: 10.1093/ageing/afi196.
PubMed 16267188Acaröz Candan, S., Çatıker, A., & Özcan, TŞ. Psychometric Properties Of The Turkish Version Of The Freezing Of Gait Questionnaire For Patients With Parkinson's Disease. Neurol Sci Neurophysiol, 2019; 36(1), 44-50.
Potter K, Brandfass K. The Mini-Balance Evaluation Systems Test (Mini-BESTest). J Physiother. 2015 Oct;61(4):225. doi: 10.1016/j.jphys.2015.04.002. Epub 2015 Jun 1. No abstract available.
PubMed 26044345Leddy AL, Crowner BE, Earhart GM. Utility of the Mini-BESTest, BESTest, and BESTest sections for balance assessments in individuals with Parkinson disease. J Neurol Phys Ther. 2011 Jun;35(2):90-7. doi: 10.1097/NPT.0b013e31821a620c.
PubMed 21934364Huang SL, Hsieh CL, Wu RM, Tai CH, Lin CH, Lu WS. Minimal detectable change of the timed "up & go" test and the dynamic gait index in people with Parkinson disease. Phys Ther. 2011 Jan;91(1):114-21. doi: 10.2522/ptj.20090126. Epub 2010 Oct 14.
PubMed 20947672Duncan RP, Earhart GM. Remote Delivery of Allied Health Therapies in Parkinson's Disease. J Parkinsons Dis. 2024;14(s1):S219-S226. doi: 10.3233/JPD-230214.
PubMed 38007673Murgia M, Pili R, Corona F, Sors F, Agostini TA, Bernardis P, Casula C, Cossu G, Guicciardi M, Pau M. The Use of Footstep Sounds as Rhythmic Auditory Stimulation for Gait Rehabilitation in Parkinson's Disease: A Randomized Controlled Trial. Front Neurol. 2018 May 24;9:348. doi: 10.3389/fneur.2018.00348. eCollection 2018.
PubMed 29910764Avanzino L, Pelosin E, Vicario CM, Lagravinese G, Abbruzzese G, Martino D. Time Processing and Motor Control in Movement Disorders. Front Hum Neurosci. 2016 Dec 12;10:631. doi: 10.3389/fnhum.2016.00631. eCollection 2016.
PubMed 28018198Ginis P, Nackaerts E, Nieuwboer A, Heremans E. Cueing for people with Parkinson's disease with freezing of gait: A narrative review of the state-of-the-art and novel perspectives. Ann Phys Rehabil Med. 2018 Nov;61(6):407-413. doi: 10.1016/j.rehab.2017.08.002. Epub 2017 Sep 7.
PubMed 28890341Maidan I, Mirelman A, Hausdorff JM, Stern Y, Habeck CG. Distinct cortical thickness patterns link disparate cerebral cortex regions to select mobility domains. Sci Rep. 2021 Mar 23;11(1):6600. doi: 10.1038/s41598-021-85058-z.
PubMed 33758214Fasano A, Herman T, Tessitore A, Strafella AP, Bohnen NI. Neuroimaging of Freezing of Gait. J Parkinsons Dis. 2015;5(2):241-54. doi: 10.3233/JPD-150536.
PubMed 25757831Spildooren J, Vercruysse S, Heremans E, Galna B, Verheyden G, Vervoort G, Nieuwboer A. Influence of Cueing and an Attentional Strategy on Freezing of Gait in Parkinson Disease During Turning. J Neurol Phys Ther. 2017 Apr;41(2):129-135. doi: 10.1097/NPT.0000000000000178.
PubMed 28263251Martin T, Weatherall M, Anderson TJ, MacAskill MR. A Randomized Controlled Feasibility Trial of a Specific Cueing Program for Falls Management in Persons With Parkinson Disease and Freezing of Gait. J Neurol Phys Ther. 2015 Jul;39(3):179-84. doi: 10.1097/NPT.0000000000000093.
PubMed 26050074Zhao Y, Nonnekes J, Storcken EJ, Janssen S, van Wegen EE, Bloem BR, Dorresteijn LD, van Vugt JP, Heida T, van Wezel RJ. Feasibility of external rhythmic cueing with the Google Glass for improving gait in people with Parkinson's disease. J Neurol. 2016 Jun;263(6):1156-65. doi: 10.1007/s00415-016-8115-2. Epub 2016 Apr 25.
PubMed 27113598
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Metronome-Based Structured Rhythmic Exercise Program on Freezing and Gait Parameters in Parkinson Disease
- ClinicalTrials.gov ID
- NCT07068217
- Acronym / sponsor ID
- E-10840098-202.3.02-221
- Conditions
- PARKINSON DISEASE (Disorder)
- Keywords
- Parkinson disease, cueing, freezing of gait
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 16 Jul 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REG | Experimental | Other: ExerciseRhythmic Exercise Group: The structured exercise program will be conducted with metronome cues tailored to each participant's cadence using the "Google Metronome" app. 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. |
| EG | Active comparator | Other: ExerciseExercise Group: Participants will perform the same exercises at their own pace, without rhythmic cues. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| ExerciseAlso: metronome exercisesSample 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 | EG, REG |
Primary outcome
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.
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
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.
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.
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
3 secondary outcomes
The International Falls Efficacy Scale (IAES)
Time frame: week 1 (beginning of the study)- week 4 (end of the study)
Parkinson's Disease Quality of Life Questionnaire (PHA-39)
Time frame: week 1 (beginning of the study)- week 4 (end of the study)
Unified Parkinson's Disease Rating Scale
Time frame: week 1-week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Results publication: PubMed 21831462Ulus Y, Durmus D, Akyol Y, Terzi Y, Bilgici A, Kuru O. Reliability and validity of the Turkish version of the Falls Efficacy Scale International (FES-I) in community-dwelling older persons. Arch Gerontol Geriatr. 2012 May-Jun;54(3):429-33. doi: 10.1016/j.archger.2011.06.010. Epub 2011 Aug 9.
- Results publication: PubMed 16267188Yardley L, Beyer N, Hauer K, Kempen G, Piot-Ziegler C, Todd C. Development and initial validation of the Falls Efficacy Scale-International (FES-I). Age Ageing. 2005 Nov;34(6):614-9. doi: 10.1093/ageing/afi196.
- Results publicationAcaröz Candan, S., Çatıker, A., & Özcan, TŞ. Psychometric Properties Of The Turkish Version Of The Freezing Of Gait Questionnaire For Patients With Parkinson's Disease. Neurol Sci Neurophysiol, 2019; 36(1), 44-50.
- Results publication: PubMed 26044345Potter K, Brandfass K. The Mini-Balance Evaluation Systems Test (Mini-BESTest). J Physiother. 2015 Oct;61(4):225. doi: 10.1016/j.jphys.2015.04.002. Epub 2015 Jun 1. No abstract available.
- Results publication: PubMed 21934364Leddy AL, Crowner BE, Earhart GM. Utility of the Mini-BESTest, BESTest, and BESTest sections for balance assessments in individuals with Parkinson disease. J Neurol Phys Ther. 2011 Jun;35(2):90-7. doi: 10.1097/NPT.0b013e31821a620c.
- Results publication: PubMed 20947672Huang SL, Hsieh CL, Wu RM, Tai CH, Lin CH, Lu WS. Minimal detectable change of the timed "up & go" test and the dynamic gait index in people with Parkinson disease. Phys Ther. 2011 Jan;91(1):114-21. doi: 10.2522/ptj.20090126. Epub 2010 Oct 14.
- Results publication: PubMed 38007673Duncan RP, Earhart GM. Remote Delivery of Allied Health Therapies in Parkinson's Disease. J Parkinsons Dis. 2024;14(s1):S219-S226. doi: 10.3233/JPD-230214.
- Results publication: PubMed 29910764Murgia M, Pili R, Corona F, Sors F, Agostini TA, Bernardis P, Casula C, Cossu G, Guicciardi M, Pau M. The Use of Footstep Sounds as Rhythmic Auditory Stimulation for Gait Rehabilitation in Parkinson's Disease: A Randomized Controlled Trial. Front Neurol. 2018 May 24;9:348. doi: 10.3389/fneur.2018.00348. eCollection 2018.
- Results publication: PubMed 28018198Avanzino L, Pelosin E, Vicario CM, Lagravinese G, Abbruzzese G, Martino D. Time Processing and Motor Control in Movement Disorders. Front Hum Neurosci. 2016 Dec 12;10:631. doi: 10.3389/fnhum.2016.00631. eCollection 2016.
- Results publication: PubMed 28890341Ginis P, Nackaerts E, Nieuwboer A, Heremans E. Cueing for people with Parkinson's disease with freezing of gait: A narrative review of the state-of-the-art and novel perspectives. Ann Phys Rehabil Med. 2018 Nov;61(6):407-413. doi: 10.1016/j.rehab.2017.08.002. Epub 2017 Sep 7.
- Results publication: PubMed 33758214Maidan I, Mirelman A, Hausdorff JM, Stern Y, Habeck CG. Distinct cortical thickness patterns link disparate cerebral cortex regions to select mobility domains. Sci Rep. 2021 Mar 23;11(1):6600. doi: 10.1038/s41598-021-85058-z.
- Results publication: PubMed 25757831Fasano A, Herman T, Tessitore A, Strafella AP, Bohnen NI. Neuroimaging of Freezing of Gait. J Parkinsons Dis. 2015;5(2):241-54. doi: 10.3233/JPD-150536.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with PARKINSON DISEASE (Disorder), run by Medipol 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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 16 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MERVE ÖZEL ÇAKIR (+90 535 584 47 44, merveozel.fzt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10m Walking Test (time frame: week 1 (beginning of study) - week 4 (end of the study)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07068217, which also lists 26 linked publications.
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 16 Jul 2025.