The Effects of Telerehabilitation-based Exercise Trainings on Gait and Balance in Parkinson's Patients
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

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.
    

Intervention name(s): Telerehabilitation Based LSVT BIG Exercise Protocol; Telerehabilitation Based Functional Balance and Mobility Exercise
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's Disease; Tele-rehabilitation; Exercise; LSVT BIG