Parkinson DiseaseNCT04694872
The Effects of Telerehabilitation-based Exercise Trainings on Gait and Balance in Parkinson's Patients
A study testing Telerehabilitation Based LSVT BIG Exercise Protocol and Telerehabilitation Based Functional Balance and Mobility Exercise in people with Parkinson Disease, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
It is planned to recruit 30 individuals with Parkinson's Disease within the scope of the study. Balance, gait, activity transfers of Parkinson's Patients will be evaluated. The study will be randomly divided into two groups. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Telerehabilitation Based LSVT BIG Exercise Protocol and Telerehabilitation Based Functional Balance and Mobility Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2021to 15 Dec 2021
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a definite diagnosis of Parkinson's disease according to the United Kingdom (UK) Brain Bank Criteria and being 1-3 on the Hoehn-Yahr scale
- A score of at least 21 on the Montreal cognitive assessment scale test
- To be able to walk independently on flat ground without assistive devices
- Stability of drug treatment taken in the last 1 month
- Patients are in the "on" period
Who cannot join
- Serious hearing or vision problems
- Having other neurological, cardiovascular, or orthopedic impairments that can prevent walking
- Any other neurological disorder (eg dementia, cerebrovascular disease)
- Have an education level of less than 5 years
- Having vascular lower extremity pathologies
- Not having internet access with a smartphone or computer
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakırköy Prof.Dr. Mazhar Osman Psychiatric and Neurological Diseases Hospital
Istanbul, Bakırköy, 34149
About this study
It is planned to recruit 30 individuals with Parkinson's Disease within the scope of the study. Balance, gait, activity transfers of Parkinson's Patients will be evaluated. The study will be randomly divided into two groups. In the first group, an exercise protocol called LSVT BIG will be applied via the Zoom application with mobile phone, tablet or computer for 4 days a week for 4 weeks. This exercise protocol consists of reliable movements suitable for the conditions of patients with large amplitudes. For the other group, balance and functional mobility exercises will be applied via the Zoom application with mobile phone, tablet or computer for 4 weeks, 4 days a week. Balance, walking and activity transfer measurements will be repeated at the end of a total of 4 weeks. It is planned to include 30 patients with a diagnosis of Parkinson's Disease (PD) with a level of 1-3 according to the Hoehn-Yahr scale, who applied to the Neurology Clinic of the Bakırköy Prof. Dr. Mazhar Osman Mental Health and Neurology Training and Research Hospital. The volunteers who will participate in the study will be informed about the purpose of the study, its duration, and the possible side effects of the treatment to be applied. Primary outcome measures include Mini Best Test, Biodex balance evaluation and Kinovea for gait assessment. Dynamic balance will be evaluated with Mini-Best Test, postural stability and fall risk will be evaluated with the Biodex Balance Device. With the camera to be placed on the sagittal, 3-meter walking distances will be recorded. Colored marks will be affixed to the right and left heels. The colored marks placed will be marked on the video and the step length and walking speed will be calculated with the Kinovea motion analysis software. In the secondary evaluations, Activity Specific Balance Confidence Scale-Short Form, Sit and Stand Test Five times, Parkinson's Activity Scale, Parkinsona Specific Quality of Life Scale (PHÖ-39) will be used.
Read the detailed description
Parkinson's Disease (PD) is a degenerative process that affects the basal ganglia, primarily substantia nigra, and other brainstem pigmented neurons, and its main clinical symptoms are resting tremor, bradykinesia, rigidity and postural reflex disorder (1). These movement symptoms usually occur unilaterally and gradually affect the other side of the body. Gait disorders are quite common in patients with Parkinson's, and the most common disabilities during walking are reduced arm swing, step length, speed, step width, and postural control inadequacy (2). One of the characteristic movement disorders in PD is hypokinesia, in which there is a decrease in motion amplitude and speed. Hypokinesia can occur during movements such as walking, speaking, and writing. When individuals with PD try to perform or coordinate two motor tasks simultaneously, hypokinesia can occur during complex actions (3). Different exercise approaches, including musculoskeletal exercises, aerobic exercises, Nordic walking, repetitive task training, sensory cues, and balance exercises have been proposed for the treatment of movement disorders and gait in these patients (4). The LSVT BIG protocol, which consists of large-amplitude exercises for movement disorders, has been used in treatment in recent years (5). High-intensity motion amplitude training in PD was firstly implemented in the form of LSVT LOUD to improve hypophonia. The newly developed LSVT BIG treatment, derived from LSVT LOUD, aims to restore the normal range of motion by re-adjusting the patient's perception of movement and walking. Treatment focuses on intense exercise of large amplitude movements. The LSVT BIG exercise intensity was determined as 16 individualized 1-hour sessions, 4 times a week for 4 weeks. Each exercise is repeated at least 8 times and is performed with an effort of 80%, with rest breaks minimized as much as possible (6). LSVT BIG training consists of maximal daily exercises, functional component tasks, BIG walking and hierarchy tasks. The aim of the training is to readjust movement during all functional tasks in the clinic and to encourage the transfer of the newly acquired motion amplitude to all non-clinical tasks. As needed, the therapist provides visual and verbal feedback to increase the amplitude of the movement. The maximum daily exercises consist of 7 versatile standard exercises performed while sitting and standing. In the functional component tasks section, it performs 5 tasks selected according to patient goals and therapists' evaluation, these tasks are performed over and over again, focusing on increasing the amplitude of motion in each session. The BIG focuses on the patient stride length and the increasing amplitude of arm swing, and the distance is determined by walking speed and endurance. In the hierarchy tasks section, the therapist designs the functional task record form based on the patient's notification, a set of movements created based on the patient's notification, and hierarchical tasks are developed in accordance with the determined functional goals. Hierarchical tasks can be advanced by increasing the complexity of the environment. In addition, the patient is instructed to apply the acquired skills in the home environment in order to maintain the principles of this education in daily life activities (7). Although LSVT BIG treatment has been shown to have positive effects on walking speed and goal-oriented activities, its effects on freezing, balance, bed mobility and transfers during walking have not yet been specified (6). Although research on the efficacy of LSVT BIG treatment is limited, the European Physiotherapy PD Guideline recommends this exercise approach to improve walking, balance, transfers and physical capacity (8). In this guide, it is seen that exercise programs that include functional activities related to balance have an important place in the rehabilitation of PD. However, there are limited studies comparing the effectiveness of exercise types and exercise methods that can provide normal range of motion with similar intensity (9). Lack of dose-response relationships in LSVT-BIG treatment, access to the clinical environment of patients for 16 sessions and four weeks, and limitations on practical applicability of the treatment were emphasized (10). The determined standard protocol imposes a significant temporal and economic burden for outpatients (11). For this reason, it is thought that performing LSVT BIG treatment via video conferencing method and remote exercise monitoring with tele-rehabilitation, will increase the participation of patients. The implementation of remote rehabilitation interventions through telerehabilitation or communication technology is used in individuals with PD as a means of overcoming barriers and increasing compliance in many patient populations with good results. It has been shown that participation in telerehabilitation and walking exercises is higher in this population than in face-to-face exercises (12). In addition, it is stated that reduced physical exercise and increased psychological stress in the Covid 19 pandemic can worsen the symptoms of PD, and it is more important than ever to encourage home-based, adequate dose exercises. During this period, remote follow-up of individuals with PD is more reliable; It is clearly seen that online exercise, dance lessons or web-based applications for patients stand out (13). The aim of our study is to compare the effects of telerehabilitation-based LSVT-BIG protocol and telerehabilitation-based functional balance and mobility exercises in Parkinson's patients.
It is planned to include 50 patients diagnosed with Parkinson's Disease (PD) with a level of 1-3 according to the Hoehn-Yahr scale, who applied to the Neurology Clinic of Bakırköy Psychiatric and Neurological Diseases Hospital between August 2020 and September 2021. The volunteers who will participate in the study will be informed about the purpose of the study, its duration, and the possible side effects of the treatment to be applied. Their consent will be obtained with the "Informed Consent Form" prepared in accordance with the standards set by the Istanbul University Cerrahpaşa Medical Faculty Clinical Research Ethics Committee and the study will be conducted in accordance with the Declaration of Helsinki.The number of cases to be taken for each group at 80% confidence interval, considering the smallest detectable difference (Smallest Detectable Difference, SDD) 3.4, and the minimal clinical significant change (Minimal Clinically Important Difference, MCID) 3.5, among the primary outcome measures 16 was determined.
Primary outcome measures include Mini Best Test, Biodex balance evaluation and Kinovea for gait assessment. Dynamic balance will be evaluated with Mini-Best Test, postural stability and fall risk will be evaluated with the Biodex Balance Device. With the camera to be placed on the sagittal, 3-meter walking distances will be recorded. Colored marks will be affixed to the right and left heels. The colored marks placed will be marked on the video and the step length and walking speed will be calculated with the Kinovea motion analysis software. In the secondary evaluations, Activity Specific Balance Confidence Scale-Short Form, Sit and Stand Test Five times, Parkinson's Activity Scale, Parkinsona Specific Quality of Life Scale (PHÖ-39) will be used.
- TELEREHABILITATION BASED LSVT BIG TREATMENT GROUP Lee Silverman Voice Treatment-LOUD therapy is a protocol involving intensive speech therapy, which was initiated at the Lee Silverman Parkinson Center between 1987-1989 to heal hypophonia in individuals with PD. LSVT-BIG, on the other hand, is a protocol derived from LSVT-LOUD, used in neurorehabilitation, consisting of focused large-amplitude functional movements performed with great effort. Maximal Daily exercises consist of seven standard exercises. Functional component tasks, on the other hand, will be created for movements in which the patient has difficulty in daily life activities selected individually based on his complaints. In hierarchical tasks, daily life activities with difficulties will be studied with large amplitudes (10). Exercises will be applied simultaneously with the physiotherapist over the Zoom application, 4 days a week, 60 minutes a day, 4 weeks protocol respectively.
- TELEREHABILITATION BASED FUNCTIONAL BALANCE AND MOBILITY EXERCISES GROUP These exercises will be applied simultaneously with the physiotherapist over the Zoom application, 4 days a week and 60 minutes a day for 4 weeks.
- Conditions
- Parkinson Disease
- Being tested
- Telerehabilitation Based LSVT BIG Exercise Protocol, Telerehabilitation Based Functional Balance and Mobility Exercise
- Keywords
- Parkinson's Disease, Tele-rehabilitation, Exercise, LSVT BIG
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation Based LSVT BIG Exercise ProtocolOther
Lee Silverman Voice Treatment-LOUD therapy is a protocol involving intensive speech therapy, which was initiated at the Lee Silverman Parkinson Center between 1987-1989 to heal hypophonia in individuals with PD. LSVT-BIG, on the other hand, is a protocol derived from LSVT-LOUD, used in neurorehabilitation, consisting of focused large-amplitude functional movements performed with great effort. Maximal Daily exercises consist of seven standard exercises. Functional component tasks, on the other hand, will be created for movements in which the patient has difficulty in daily life activities selected individually based on his complaints. In hierarchical tasks, daily life activities with difficulties will be studied with large amplitudes. Exercises will be applied simultaneously with the physiotherapist over the Zoom application, 4 days a week, 60 minutes a day, 4 weeks protocol respectively.
Telerehabilitation Based Functional Balance and Mobility ExerciseOther
These exercises will be applied simultaneously with the physiotherapist over the Zoom application, 4 days a week and 60 minutes a day for 4 weeks.
Exercises will get harder with each passing week and its progression will be adjusted to the patient.
| Study group | Role | What they receive |
|---|---|---|
| a) TELEREHABILITATION BASED LSVT BIG TREATMENT GROUP | Experimental | It is planned to recruit 16 patients with Parkinson's Disease in this group. Exercises will be applied simultaneously with the physiotherapist over the Zoom application, 4 days a week, 60 minutes a day, 4 weeks protocol respectively. Receives: Other: Telerehabilitation Based LSVT BIG Exercise Protocol |
| b) TELEREHABILITATION BASED FUNCTIONAL BALANCE AND MOBILITY EXERCISES GROUP | Active comparator | It is planned to recruit 16 patients with Parkinson's Disease in this group. These exercises will be applied simultaneously with the physiotherapist over the Zoom application, 4 days a week and 60 minutes a day for 4 weeks. Receives: Other: Telerehabilitation Based Functional Balance and Mobility Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Best Test
The Mini-BEST balance scale will be used in the assessment of dynamic balance, this scale is a one-dimensional and highly reliable measurement method with 14 items, requiring approximately 15 minutes to complete. The Mini-BEST test focuses on postural responses, dynamic gait and sensory orientation to reveal balance problems and is frequently used in Parkinson's patients. Each item is scored between 0 and 2. A score of 0 indicates that the person cannot fulfill that task, 28 points is the best indicator.
Measured: 15 minutes
Biodex Balance Assessment
The Biodex Balance System (BBS; Biodex Medical System Inc., Shirley, NY, USA) will be used to measure the displacement of the center of foot pressure (CoP). Biodex Balance System 20 Hz. It consists of a circular platform that allows 20 degrees of platform tilt in a range of 360 degrees of motion at sampling rate. Measures of postural stability score for BBS; It is in the form of the General Stability Index (OSI), Medial-Lateral Stability Index (MLSI) and Anterior-Posterior Stability Index (APSI). The degree of unbalance of the surface can be adjusted from the most stable (level 8) to the least stable levels (level 1)
Measured: 10 minutes
Kinovea Gait Analysis
3 meters walking distance will be recorded with the camera to be placed in the sagittal. Colored markings will be affixed to the right and left heels. The colored marks placed will be marked on the video and step lengths, walking speed and arm swing will be calculated with the Kinovea motion analysis software. The video will express the cadence (number of steps per minute), right and left stride lengths
Measured: 15 minutes
Timed Up and Go (TUG) Test
Timed Up and Go (TUG) test is a simple, widely used and rapid test to evaluate mobility, balance and fall risk. To perform the test, participants must stand up from a standard chair, walk comfortably 3 meters from the ground, turn and return to the chair, and sit on the same chair. All steps of the test will be measured using a stopwatch
Measured: 10 minutes
Secondary outcomes (4)
Activity Specific Balance Confidence Scale - Short Form:
The short form of Activity Specific Balance Confidence Scale will be used to measure patients' balance confidence. Activity-Specific Balance Confidence Scale is answered with the self-perception of the individual, which consists of 16 items. It includes values in the range of 0-100 and measures the perceived ability to maintain balance under different conditions. The highest score indicates full confidence in their balance abilities. The short form of this scale consists of 6 questions of the original version of the scale and it has been stated that it is valid and reliable when associated with the risk of falling in the PD population.
Measured: 5 minutes
Five Times Sit & Stand Test
This test will be used in our study to determine repetitive motion performance. Individuals will be instructed to cross their arms over their chest and sit down to rest their back against the back of the chair. He will be asked to sit and stand five times as soon as possible, and then time will be recorded. The performance of this test in individuals with PD has been found to be associated with balance and bradykinesia and has been recommended as a reliable method
Measured: 5 minutes
Parkinson Activity Scale
It is a scale developed to evaluate the functional status in PD. It consists of a total of 10 items, including the sections of standing up from the chair, walking akinesia and in-bed mobilization, and provides information about the transfer status of the patients. Evaluations are made between 0 and 4, and a high score is an indicator of good performance
Measured: 15 minutes
Parkinson-Specific Quality of Life Scale
The Parkinson-Specific Quality of Life Scale will be used in quality of life assessment. PDQ-39 is a self-report questionnaire that uses the 5-point Likert scale to assess the quality of life such as the severity of symptoms of mobility, daily living activities, emotional well-being, social support, cognition, and communication. The total score is between 0-100, and the higher the score indicates that the quality of life is at a lower level
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start15 Jan 2021
- Primary completion15 Feb 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Guzin Kaya Aytutuldu, Yeditepe University
- Investigators
- Burcu Ersoz Huseyinsinoglu, Assoc.Prof, Study director, Istanbul University - CerrahpasaNazan Karagoz Sakallı, MD, Study chair, Bakırköy Prof.Dr. Mazhar Osman Psychiatric and Neurological Diseases HospitalAysu Sen, Assoc.Prof., Study chair, Bakırköy Prof.Dr. Mazhar Osman Psychiatric and Neurological Diseases Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694872
- Sponsor's protocol ID
- Istanbul University Cerrahpasa
- Status last verified
- Dec 2022
- First submitted
- 3 Jan 2021
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ebersbach G, Grust U, Ebersbach A, Wegner B, Gandor F, Kuhn AA. Amplitude-oriented exercise in Parkinson's disease: a randomized study comparing LSVT-BIG and a short training protocol. J Neural Transm (Vienna). 2015 Feb;122(2):253-6. doi: 10.1007/s00702-014-1245-8. Epub 2014 May 29.
PubMed 24872078Millage B, Vesey E, Finkelstein M, Anheluk M. Effect on Gait Speed, Balance, Motor Symptom Rating, and Quality of Life in Those with Stage I Parkinson's Disease Utilizing LSVT BIG(R). Rehabil Res Pract. 2017;2017:9871070. doi: 10.1155/2017/9871070. Epub 2017 Feb 26.
PubMed 28331638Strouwen C, Molenaar EALM, Munks L, Keus SHJ, Zijlmans JCM, Vandenberghe W, Bloem BR, Nieuwboer A. Training dual tasks together or apart in Parkinson's disease: Results from the DUALITY trial. Mov Disord. 2017 Aug;32(8):1201-1210. doi: 10.1002/mds.27014. Epub 2017 Apr 25.
PubMed 28440888Strouwen C, Molenaar EA, Keus SH, Munks L, Munneke M, Vandenberghe W, Bloem BR, Nieuwboer A. Protocol for a randomized comparison of integrated versus consecutive dual task practice in Parkinson's disease: the DUALITY trial. BMC Neurol. 2014 Mar 27;14:61. doi: 10.1186/1471-2377-14-61.
PubMed 24674594van der Kolk NM, King LA. Effects of exercise on mobility in people with Parkinson's disease. Mov Disord. 2013 Sep 15;28(11):1587-96. doi: 10.1002/mds.25658.
PubMed 24132847Janssens J, Malfroid K, Nyffeler T, Bohlhalter S, Vanbellingen T. Application of LSVT BIG intervention to address gait, balance, bed mobility, and dexterity in people with Parkinson disease: a case series. Phys Ther. 2014 Jul;94(7):1014-23. doi: 10.2522/ptj.20130232. Epub 2014 Feb 20.
PubMed 24557655Fishel SC, Hotchkiss ME, Brown SA. The impact of LSVT BIG therapy on postural control for individuals with Parkinson disease: A case series. Physiother Theory Pract. 2020 Jul;36(7):834-843. doi: 10.1080/09593985.2018.1508260. Epub 2018 Aug 17.
PubMed 30118624Domingos J, Keus SHJ, Dean J, de Vries NM, Ferreira JJ, Bloem BR. The European Physiotherapy Guideline for Parkinson's Disease: Implications for Neurologists. J Parkinsons Dis. 2018;8(4):499-502. doi: 10.3233/JPD-181383.
PubMed 30149464Fox C, Ebersbach G, Ramig L, Sapir S. LSVT LOUD and LSVT BIG: Behavioral Treatment Programs for Speech and Body Movement in Parkinson Disease. Parkinsons Dis. 2012;2012:391946. doi: 10.1155/2012/391946. Epub 2012 Mar 15.
PubMed 22530161Ellis T, Latham NK, DeAngelis TR, Thomas CA, Saint-Hilaire M, Bickmore TW. Feasibility of a virtual exercise coach to promote walking in community-dwelling persons with Parkinson disease. Am J Phys Med Rehabil. 2013 Jun;92(6):472-81; quiz 482-5. doi: 10.1097/PHM.0b013e31828cd466.
PubMed 23552335Helmich RC, Bloem BR. The Impact of the COVID-19 Pandemic on Parkinson's Disease: Hidden Sorrows and Emerging Opportunities. J Parkinsons Dis. 2020;10(2):351-354. doi: 10.3233/JPD-202038. No abstract available.
PubMed 32250324McDonnell MN, Rischbieth B, Schammer TT, Seaforth C, Shaw AJ, Phillips AC. Lee Silverman Voice Treatment (LSVT)-BIG to improve motor function in people with Parkinson's disease: a systematic review and meta-analysis. Clin Rehabil. 2018 May;32(5):607-618. doi: 10.1177/0269215517734385. Epub 2017 Oct 5.
PubMed 28980476Kaya Aytutuldu G, Ersoz Huseyinsinoglu B, Karagoz Sakalli N, Sen A, Yeldan I. LSVT(R) BIG versus progressive structured mobility training through synchronous telerehabilitation in Parkinson's disease: A randomized controlled trial. Neurol Sci. 2024 Jul;45(7):3163-3172. doi: 10.1007/s10072-024-07322-0. Epub 2024 Jan 25.
PubMed 38267603
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Telerehabilitation-based Exercise Trainings on Gait and Balance in Parkinson's Patients
- ClinicalTrials.gov ID
- NCT04694872
- Acronym / sponsor ID
- Istanbul University Cerrahpasa
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Tele-rehabilitation, Exercise, LSVT BIG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 5 Jan 2021 (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.
It is planned to recruit 30 individuals with Parkinson's Disease within the scope of the study. Balance, gait, activity transfers of Parkinson's Patients will be evaluated. The study will be randomly divided into two groups. In the first group, an exercise protocol called LSVT BIG will be applied via the Zoom application with mobile phone, tablet or computer for 4 days a week for 4 weeks. This exercise protocol consists of reliable movements suitable for the conditions of patients with large amplitudes. For the other group, balance and functional mobility exercises will be applied via the Zoom application with mobile phone, tablet or computer for 4 weeks, 4 days a week. Balance, walking and activity transfer measurements will be repeated at the end of a total of 4 weeks. It is planned to include 30 patients with a diagnosis of Parkinson's Disease (PD) with a level of 1-3 according to the Hoehn-Yahr scale, who applied to the Neurology Clinic of the Bakırköy Prof. Dr. Mazhar Osman Mental Health and Neurology Training and Research Hospital. The volunteers who will participate in the study will be informed about the purpose of the study, its duration, and the possible side effects of the treatment to be applied. Primary outcome measures include Mini Best Test, Biodex balance evaluation and Kinovea for gait assessment. Dynamic balance will be evaluated with Mini-Best Test, postural stability and fall risk will be evaluated with the Biodex Balance Device. With the camera to be placed on the sagittal, 3-meter walking distances will be recorded. Colored marks will be affixed to the right and left heels. The colored marks placed will be marked on the video and the step length and walking speed will be calculated with the Kinovea motion analysis software. In the secondary evaluations, Activity Specific Balance Confidence Scale-Short Form, Sit and Stand Test Five times, Parkinson's Activity Scale, Parkinsona Specific Quality of Life Scale (PHÖ-39) will be used.
Detailed description
Parkinson's Disease (PD) is a degenerative process that affects the basal ganglia, primarily substantia nigra, and other brainstem pigmented neurons, and its main clinical symptoms are resting tremor, bradykinesia, rigidity and postural reflex disorder (1). These movement symptoms usually occur unilaterally and gradually affect the other side of the body. Gait disorders are quite common in patients with Parkinson's, and the most common disabilities during walking are reduced arm swing, step length, speed, step width, and postural control inadequacy (2). One of the characteristic movement disorders in PD is hypokinesia, in which there is a decrease in motion amplitude and speed. Hypokinesia can occur during movements such as walking, speaking, and writing. When individuals with PD try to perform or coordinate two motor tasks simultaneously, hypokinesia can occur during complex actions (3). Different exercise approaches, including musculoskeletal exercises, aerobic exercises, Nordic walking, repetitive task training, sensory cues, and balance exercises have been proposed for the treatment of movement disorders and gait in these patients (4). The LSVT BIG protocol, which consists of large-amplitude exercises for movement disorders, has been used in treatment in recent years (5). High-intensity motion amplitude training in PD was firstly implemented in the form of LSVT LOUD to improve hypophonia. The newly developed LSVT BIG treatment, derived from LSVT LOUD, aims to restore the normal range of motion by re-adjusting the patient's perception of movement and walking. Treatment focuses on intense exercise of large amplitude movements. The LSVT BIG exercise intensity was determined as 16 individualized 1-hour sessions, 4 times a week for 4 weeks. Each exercise is repeated at least 8 times and is performed with an effort of 80%, with rest breaks minimized as much as possible (6). LSVT BIG training consists of maximal daily exercises, functional component tasks, BIG walking and hierarchy tasks. The aim of the training is to readjust movement during all functional tasks in the clinic and to encourage the transfer of the newly acquired motion amplitude to all non-clinical tasks. As needed, the therapist provides visual and verbal feedback to increase the amplitude of the movement. The maximum daily exercises consist of 7 versatile standard exercises performed while sitting and standing. In the functional component tasks section, it performs 5 tasks selected according to patient goals and therapists' evaluation, these tasks are performed over and over again, focusing on increasing the amplitude of motion in each session. The BIG focuses on the patient stride length and the increasing amplitude of arm swing, and the distance is determined by walking speed and endurance. In the hierarchy tasks section, the therapist designs the functional task record form based on the patient's notification, a set of movements created based on the patient's notification, and hierarchical tasks are developed in accordance with the determined functional goals. Hierarchical tasks can be advanced by increasing the complexity of the environment. In addition, the patient is instructed to apply the acquired skills in the home environment in order to maintain the principles of this education in daily life activities (7). Although LSVT BIG treatment has been shown to have positive effects on walking speed and goal-oriented activities, its effects on freezing, balance, bed mobility and transfers during walking have not yet been specified (6). Although research on the efficacy of LSVT BIG treatment is limited, the European Physiotherapy PD Guideline recommends this exercise approach to improve walking, balance, transfers and physical capacity (8). In this guide, it is seen that exercise programs that include functional activities related to balance have an important place in the rehabilitation of PD. However, there are limited studies comparing the effectiveness of exercise types and exercise methods that can provide normal range of motion with similar intensity (9). Lack of dose-response relationships in LSVT-BIG treatment, access to the clinical environment of patients for 16 sessions and four weeks, and limitations on practical applicability of the treatment were emphasized (10). The determined standard protocol imposes a significant temporal and economic burden for outpatients (11). For this reason, it is thought that performing LSVT BIG treatment via video conferencing method and remote exercise monitoring with tele-rehabilitation, will increase the participation of patients. The implementation of remote rehabilitation interventions through telerehabilitation or communication technology is used in individuals with PD as a means of overcoming barriers and increasing compliance in many patient populations with good results. It has been shown that participation in telerehabilitation and walking exercises is higher in this population than in face-to-face exercises (12). In addition, it is stated that reduced physical exercise and increased psychological stress in the Covid 19 pandemic can worsen the symptoms of PD, and it is more important than ever to encourage home-based, adequate dose exercises. During this period, remote follow-up of individuals with PD is more reliable; It is clearly seen that online exercise, dance lessons or web-based applications for patients stand out (13). The aim of our study is to compare the effects of telerehabilitation-based LSVT-BIG protocol and telerehabilitation-based functional balance and mobility exercises in Parkinson's patients.
It is planned to include 50 patients diagnosed with Parkinson's Disease (PD) with a level of 1-3 according to the Hoehn-Yahr scale, who applied to the Neurology Clinic of Bakırköy Psychiatric and Neurological Diseases Hospital between August 2020 and September 2021. The volunteers who will participate in the study will be informed about the purpose of the study, its duration, and the possible side effects of the treatment to be applied. Their consent will be obtained with the "Informed Consent Form" prepared in accordance with the standards set by the Istanbul University Cerrahpaşa Medical Faculty Clinical Research Ethics Committee and the study will be conducted in accordance with the Declaration of Helsinki.The number of cases to be taken for each group at 80% confidence interval, considering the smallest detectable difference (Smallest Detectable Difference, SDD) 3.4, and the minimal clinical significant change (Minimal Clinically Important Difference, MCID) 3.5, among the primary outcome measures 16 was determined.
Primary outcome measures include Mini Best Test, Biodex balance evaluation and Kinovea for gait assessment. Dynamic balance will be evaluated with Mini-Best Test, postural stability and fall risk will be evaluated with the Biodex Balance Device. With the camera to be placed on the sagittal, 3-meter walking distances will be recorded. Colored marks will be affixed to the right and left heels. The colored marks placed will be marked on the video and the step length and walking speed will be calculated with the Kinovea motion analysis software. In the secondary evaluations, Activity Specific Balance Confidence Scale-Short Form, Sit and Stand Test Five times, Parkinson's Activity Scale, Parkinsona Specific Quality of Life Scale (PHÖ-39) will be used.
- TELEREHABILITATION BASED LSVT BIG TREATMENT GROUP Lee Silverman Voice Treatment-LOUD therapy is a protocol involving intensive speech therapy, which was initiated at the Lee Silverman Parkinson Center between 1987-1989 to heal hypophonia in individuals with PD. LSVT-BIG, on the other hand, is a protocol derived from LSVT-LOUD, used in neurorehabilitation, consisting of focused large-amplitude functional movements performed with great effort. Maximal Daily exercises consist of seven standard exercises. Functional component tasks, on the other hand, will be created for movements in which the patient has difficulty in daily life activities selected individually based on his complaints. In hierarchical tasks, daily life activities with difficulties will be studied with large amplitudes (10). Exercises will be applied simultaneously with the physiotherapist over the Zoom application, 4 days a week, 60 minutes a day, 4 weeks protocol respectively.
- TELEREHABILITATION BASED FUNCTIONAL BALANCE AND MOBILITY EXERCISES GROUP These exercises will be applied simultaneously with the physiotherapist over the Zoom application, 4 days a week and 60 minutes a day for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| a) TELEREHABILITATION BASED LSVT BIG TREATMENT GROUP | Experimental | Other: Telerehabilitation Based LSVT BIG Exercise ProtocolIt is planned to recruit 16 patients with Parkinson's Disease in this group. Exercises will be applied simultaneously with the physiotherapist over the Zoom application, 4 days a week, 60 minutes a day, 4 weeks protocol respectively. |
| b) TELEREHABILITATION BASED FUNCTIONAL BALANCE AND MOBILITY EXERCISES GROUP | Active comparator | Other: Telerehabilitation Based Functional Balance and Mobility ExerciseIt is planned to recruit 16 patients with Parkinson's Disease in this group. These exercises will be applied simultaneously with the physiotherapist over the Zoom application, 4 days a week and 60 minutes a day for 4 weeks. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having a definite diagnosis of Parkinson's disease according to the United Kingdom (UK) Brain Bank Criteria and being 1-3 on the Hoehn-Yahr scale
- A score of at least 21 on the Montreal cognitive assessment scale test
- To be able to walk independently on flat ground without assistive devices
- Stability of drug treatment taken in the last 1 month
- Patients are in the "on" period
Key exclusion criteria (6 listed)
- Serious hearing or vision problems
- Having other neurological, cardiovascular, or orthopedic impairments that can prevent walking
- Any other neurological disorder (eg dementia, cerebrovascular disease)
- Have an education level of less than 5 years
- Having vascular lower extremity pathologies
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 |
|---|---|---|
| Telerehabilitation Based LSVT BIG Exercise ProtocolLee Silverman Voice Treatment-LOUD therapy is a protocol involving intensive speech therapy, which was initiated at the Lee Silverman Parkinson Center between 1987-1989 to heal hypophonia in individuals with PD. LSVT-BIG, on the other hand, is a protocol derived from LSVT-LOUD, used in neurorehabilitation, consisting of focused large-amplitude functional movements performed with great effort. Maximal Daily exercises consist of seven standard exercises. Functional component tasks, on the other hand, will be created for movements in which the patient has difficulty in daily life activities selected individually based on his complaints. In hierarchical tasks, daily life activities with difficulties will be studied with large amplitudes. Exercises will be applied simultaneously with the physiotherapist over the Zoom application, 4 days a week, 60 minutes a day, 4 weeks protocol respectively. | Other | a) TELEREHABILITATION BASED LSVT BIG TREATMENT GROUP |
| Telerehabilitation Based Functional Balance and Mobility ExerciseThese exercises will be applied simultaneously with the physiotherapist over the Zoom application, 4 days a week and 60 minutes a day for 4 weeks. Exercises will get harder with each passing week and its progression will be adjusted to the patient. | Other | b) TELEREHABILITATION BASED FUNCTIONAL BALANCE AND MOBILITY EXERCISES GROUP |
Primary outcome
Mini-Best Test
Time frame: 15 minutes
The Mini-BEST balance scale will be used in the assessment of dynamic balance, this scale is a one-dimensional and highly reliable measurement method with 14 items, requiring approximately 15 minutes to complete. The Mini-BEST test focuses on postural responses, dynamic gait and sensory orientation to reveal balance problems and is frequently used in Parkinson's patients. Each item is scored between 0 and 2. A score of 0 indicates that the person cannot fulfill that task, 28 points is the best indicator.
Biodex Balance Assessment
Time frame: 10 minutes
The Biodex Balance System (BBS; Biodex Medical System Inc., Shirley, NY, USA) will be used to measure the displacement of the center of foot pressure (CoP). Biodex Balance System 20 Hz. It consists of a circular platform that allows 20 degrees of platform tilt in a range of 360 degrees of motion at sampling rate. Measures of postural stability score for BBS; It is in the form of the General Stability Index (OSI), Medial-Lateral Stability Index (MLSI) and Anterior-Posterior Stability Index (APSI). The degree of unbalance of the surface can be adjusted from the most stable (level 8) to the least stable levels (level 1)
Kinovea Gait Analysis
Time frame: 15 minutes
3 meters walking distance will be recorded with the camera to be placed in the sagittal. Colored markings will be affixed to the right and left heels. The colored marks placed will be marked on the video and step lengths, walking speed and arm swing will be calculated with the Kinovea motion analysis software. The video will express the cadence (number of steps per minute), right and left stride lengths
Timed Up and Go (TUG) Test
Time frame: 10 minutes
Timed Up and Go (TUG) test is a simple, widely used and rapid test to evaluate mobility, balance and fall risk. To perform the test, participants must stand up from a standard chair, walk comfortably 3 meters from the ground, turn and return to the chair, and sit on the same chair. All steps of the test will be measured using a stopwatch
4 secondary outcomes
Activity Specific Balance Confidence Scale - Short Form:
Time frame: 5 minutes
Five Times Sit & Stand Test
Time frame: 5 minutes
Parkinson Activity Scale
Time frame: 15 minutes
Parkinson-Specific Quality of Life Scale
Time frame: 15 minutes
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 9 Dec 2022.
- Background: PubMed 24872078Ebersbach G, Grust U, Ebersbach A, Wegner B, Gandor F, Kuhn AA. Amplitude-oriented exercise in Parkinson's disease: a randomized study comparing LSVT-BIG and a short training protocol. J Neural Transm (Vienna). 2015 Feb;122(2):253-6. doi: 10.1007/s00702-014-1245-8. Epub 2014 May 29.
- Background: PubMed 28331638Millage B, Vesey E, Finkelstein M, Anheluk M. Effect on Gait Speed, Balance, Motor Symptom Rating, and Quality of Life in Those with Stage I Parkinson's Disease Utilizing LSVT BIG(R). Rehabil Res Pract. 2017;2017:9871070. doi: 10.1155/2017/9871070. Epub 2017 Feb 26.
- Background: PubMed 28440888Strouwen C, Molenaar EALM, Munks L, Keus SHJ, Zijlmans JCM, Vandenberghe W, Bloem BR, Nieuwboer A. Training dual tasks together or apart in Parkinson's disease: Results from the DUALITY trial. Mov Disord. 2017 Aug;32(8):1201-1210. doi: 10.1002/mds.27014. Epub 2017 Apr 25.
- Background: PubMed 24674594Strouwen C, Molenaar EA, Keus SH, Munks L, Munneke M, Vandenberghe W, Bloem BR, Nieuwboer A. Protocol for a randomized comparison of integrated versus consecutive dual task practice in Parkinson's disease: the DUALITY trial. BMC Neurol. 2014 Mar 27;14:61. doi: 10.1186/1471-2377-14-61.
- Background: PubMed 24132847van der Kolk NM, King LA. Effects of exercise on mobility in people with Parkinson's disease. Mov Disord. 2013 Sep 15;28(11):1587-96. doi: 10.1002/mds.25658.
- Background: PubMed 24557655Janssens J, Malfroid K, Nyffeler T, Bohlhalter S, Vanbellingen T. Application of LSVT BIG intervention to address gait, balance, bed mobility, and dexterity in people with Parkinson disease: a case series. Phys Ther. 2014 Jul;94(7):1014-23. doi: 10.2522/ptj.20130232. Epub 2014 Feb 20.
- Background: PubMed 30118624Fishel SC, Hotchkiss ME, Brown SA. The impact of LSVT BIG therapy on postural control for individuals with Parkinson disease: A case series. Physiother Theory Pract. 2020 Jul;36(7):834-843. doi: 10.1080/09593985.2018.1508260. Epub 2018 Aug 17.
- Background: PubMed 30149464Domingos J, Keus SHJ, Dean J, de Vries NM, Ferreira JJ, Bloem BR. The European Physiotherapy Guideline for Parkinson's Disease: Implications for Neurologists. J Parkinsons Dis. 2018;8(4):499-502. doi: 10.3233/JPD-181383.
- Background: PubMed 22530161Fox C, Ebersbach G, Ramig L, Sapir S. LSVT LOUD and LSVT BIG: Behavioral Treatment Programs for Speech and Body Movement in Parkinson Disease. Parkinsons Dis. 2012;2012:391946. doi: 10.1155/2012/391946. Epub 2012 Mar 15.
- Background: PubMed 23552335Ellis T, Latham NK, DeAngelis TR, Thomas CA, Saint-Hilaire M, Bickmore TW. Feasibility of a virtual exercise coach to promote walking in community-dwelling persons with Parkinson disease. Am J Phys Med Rehabil. 2013 Jun;92(6):472-81; quiz 482-5. doi: 10.1097/PHM.0b013e31828cd466.
- Background: PubMed 32250324Helmich RC, Bloem BR. The Impact of the COVID-19 Pandemic on Parkinson's Disease: Hidden Sorrows and Emerging Opportunities. J Parkinsons Dis. 2020;10(2):351-354. doi: 10.3233/JPD-202038. No abstract available.
- Results publication: PubMed 28980476McDonnell MN, Rischbieth B, Schammer TT, Seaforth C, Shaw AJ, Phillips AC. Lee Silverman Voice Treatment (LSVT)-BIG to improve motor function in people with Parkinson's disease: a systematic review and meta-analysis. Clin Rehabil. 2018 May;32(5):607-618. doi: 10.1177/0269215517734385. Epub 2017 Oct 5.
- Individual participant dataSharing planned: No
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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.
Burcu Ersoz Huseyinsinoglu, Assoc.Prof study director
Istanbul University - Cerrahpasa
Nazan Karagoz Sakallı, MD study chair
Bakırköy Prof.Dr. Mazhar Osman Psychiatric and Neurological Diseases Hospital
Aysu Sen, Assoc.Prof. study chair
Bakırköy Prof.Dr. Mazhar Osman Psychiatric and Neurological Diseases Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation Based LSVT BIG Exercise Protocol and Telerehabilitation Based Functional Balance and Mobility Exercise in people with Parkinson Disease, run by Yeditepe 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 5 inclusion and 6 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 9 Dec 2022. 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?
Mini-Best Test (time frame: 15 minutes). The study lists 4 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 NCT04694872, which also lists 13 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 9 Dec 2022; AzTrials last refreshed its copy on 7 Nov 2026.