The Effects of Telerehabilitation-based Exercise Trainings on Gait and Balance in Parkinson's Patients

NCT ID: NCT04694872

Last Updated: 2022-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2021-12-15

Brief 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. 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.

1. 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.

2. 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

Keywords

Parkinson's Disease; Tele-rehabilitation; Exercise; LSVT BIG

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

a) TELEREHABILITATION BASED LSVT BIG TREATMENT GROUP

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.

Group Type: EXPERIMENTAL

Telerehabilitation Based LSVT BIG Exercise Protocol

Intervention Type: OTHER

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.

b) TELEREHABILITATION BASED FUNCTIONAL BALANCE AND MOBILITY EXERCISES GROUP

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.

Group Type: ACTIVE_COMPARATOR

Telerehabilitation Based Functional Balance and Mobility Exercise

Intervention Type: OTHER

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.

Interventions

Telerehabilitation Based LSVT BIG Exercise Protocol

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.

Intervention Type: OTHER

Telerehabilitation Based Functional Balance and Mobility Exercise

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: collaborator

Yeditepe University

OTHER

Sponsor Role: lead

Responsible Party

Guzin Kaya Aytutuldu

Principla Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Burcu Ersoz Huseyinsinoglu, Assoc.Prof

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Nazan Karagoz Sakallı, MD

Role: STUDY_CHAIR

Bakırköy Prof.Dr. Mazhar Osman Psychiatric and Neurological Diseases Hospital

Aysu Sen, Assoc.Prof.

Role: STUDY_CHAIR

Bakırköy Prof.Dr. Mazhar Osman Psychiatric and Neurological Diseases Hospital

Locations

Bakırköy Prof.Dr. Mazhar Osman Psychiatric and Neurological Diseases Hospital

Istanbul, Bakırköy, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Strouwen 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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Fishel 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.

Reference Type: BACKGROUND

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Domingos 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.

Reference Type: BACKGROUND

PMID: 30149464 (View on PubMed)

Fox 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.

Reference Type: BACKGROUND

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Ellis 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.

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Reference Type: BACKGROUND

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Reference Type: RESULT

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Kaya 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.

Reference Type: DERIVED

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Other Identifiers

Istanbul University Cerrahpasa

Identifier Type: -

Identifier Source: org_study_id