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

NCT04694872 | Completed DMC

• 1 other identifier: Istanbul University Cerrahpasa
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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)

  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

  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

  10 minutes

Secondary Outcomes (4)

• Activity Specific Balance Confidence Scale - Short Form:

  5 minutes

• Five Times Sit & Stand Test

  5 minutes

• Parkinson Activity Scale

  15 minutes

• Parkinson-Specific Quality of Life Scale

  15 minutes

Study Arms (2)

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.

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.

Other: Telerehabilitation Based Functional Balance and Mobility Exercise

Interventions

Telerehabilitation Based LSVT BIG Exercise Protocol 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.

a) TELEREHABILITATION BASED LSVT BIG TREATMENT GROUP

Telerehabilitation Based Functional Balance and Mobility Exercise 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.

b) TELEREHABILITATION BASED FUNCTIONAL BALANCE AND MOBILITY EXERCISES GROUP

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yeditepe University: lead
• Istanbul University - Cerrahpasa: collaborator

Study Sites (1)

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

Istanbul, Bakırköy, 34149, Turkey (Türkiye)

Location

Related Publications (13)

• 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.

  PMID: 24872078 BACKGROUND

• Millage 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.

  PMID: 28331638 BACKGROUND

• 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.

  PMID: 28440888 BACKGROUND

• Strouwen 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.

  PMID: 24674594 BACKGROUND

• van 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.

  PMID: 24132847 BACKGROUND

• Janssens 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.

  PMID: 24557655 BACKGROUND

• 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.

  PMID: 30118624 BACKGROUND

• 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.

  PMID: 30149464 BACKGROUND

• 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.

  PMID: 22530161 BACKGROUND

• 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.

  PMID: 23552335 BACKGROUND

• Helmich 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.

  PMID: 32250324 BACKGROUND

• McDonnell 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.

  PMID: 28980476 RESULT

• 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.

  PMID: 38267603 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Study Officials

• Burcu Ersoz Huseyinsinoglu, Assoc.Prof

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

• Nazan Karagoz Sakallı, MD

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

  STUDY CHAIR

• Aysu Sen, Assoc.Prof.

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principla Investigator

Study Record Dates

• First Submitted: January 3, 2021
• First Posted: January 5, 2021
• Study Start: January 15, 2021
• Primary Completion: February 15, 2021
• Study Completion: December 15, 2021
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)