Investigation of the Effects of LSVT-BlG Protocol on Balance, Gait, Fatigue and Quality of Life in Parkinson's Patients

Master's Thesis on the Investigation of the Effects of LSVT-BlG Protocol on Balance, Gait, Fatigue and Quality of Life in Parkinson's Patients

Parkinson's disease is a progressive, degenerative neurological disease manifested by motor and non-motor symptoms. Treatment for Parkinson's disease is symptom-oriented. Treatment options include medical treatment and surgical treatment, as well as physiotherapy and rehabilitation interventions. The LSVT-BIG protocol, a physiotherapy and rehabilitation intervention, aims to overcome the insufficient speed-amplitude regulation that leads to low scaling of motion amplitude at any speed in Parkinson's disease. The protocol is applied for four weeks, four days a week, and each session is one hour. Each treatment session consists of four parts: maximal daily exercises, functional component tasks, hierarchy tasks, and grand walking. Telerehabilitation is a system established for the online delivery of different rehabilitation services via telecommunication, and it has been reported that the LSVT-BIG protocol is a viable method with image-based video conferencing systems.

This study is a randomized controlled trial designed to examine the effect of the LSVT-BIG protocol on balance, gait, fatigue and quality of life. In this direction, thirty-four Parkinson's patients will be divided into two groups by randomization method after a preliminary evaluation including balance, gait, fatigue and quality of life variables. While the telerehabilitation-based LSVT-BIG protocol was applied to the experimental group for four weeks, no physiotherapy and rehabilitation interventions would be applied to the control group in addition to the medical treatment for the same period. At the end of four weeks, both groups will be evaluated again, including balance, gait, fatigue and quality of life variables. Evaluation data will be collected from patients through face-to-face evaluation methods and prepared questionnaires and scales. The obtained data will be evaluated using appropriate statistical methods using the SPSS statistical program.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: LSVT-BIG Group via Telerehabilitation

Detailed Description

Parkinson's disease is a progressive, degenerative neurological disease manifested by motor and non-motor symptoms. Motor symptoms include resting tremor, bradykinesia, postural instability, rigidity, postural deformities, and gait disturbances. Non-motor symptoms include cognition and behavioral disorders, autonomic dysfunctions, sleep and sensory disturbances. These symptoms reduce the quality of life of patients and prevent participation in activities of daily living. Treatment for Parkinson's disease is symptom-oriented. These treatment options include medical treatment and surgical treatment, as well as physiotherapy and rehabilitation interventions.

Physiotherapy and rehabilitation interventions aim to maximize functional ability, minimize secondary complications, control unwanted side effects of medical treatment and possible motor fluctuations. For this purpose, intervention methods such as aerobic and strengthening exercises, balance and gait training, motor learning and movement strategies and the LSVT-BIG protocol are used in physiotherapy and rehabilitation programs.

LSVT-BIG protocol; derived from the Lee Silverman Voice Treatment protocol developed to improve hypophonia in Parkinson's patients, it is a treatment protocol that includes large amplitude body movements to increase both the speed and amplitude of functional movements. The goal of this protocol is to overcome the insufficient speed-amplitude regulation that leads to low scaling of the amplitude of motion at any given speed. Continuous feedback on motor performance and motion perception training in the protocol is used to offset the reduced gain in motor activities as a result of impaired sensorimotor processing. The protocol is applied for four weeks, four days a week, and each session is one hour. Each treatment session consists of four parts: maximal daily exercises, functional component tasks, hierarchy tasks, and big walking. In the study of Fishel et al., the LSVT-BIG protocol was applied to patients with intermediate Parkinson's disease. According to the results of this study, the LSVT-BIG protocol has a positive effect on balance, fall and walking variables. The study by Farley et al. showed that the LSVT-BIG protocol improved gait. It has been reported that improvement is higher especially in Hoehn Yahr stage 1 Parkinson's patients. The study by Sundaran et al suggests that balance ability in patients with Parkinson's is improved by the LSVT-BIG protocol, as assessed using the Berg Balance Scale.

Telerehabilitation is a system established for the remote delivery of different rehabilitation services via telecommunication. Online access provides advantages in terms of distance, time and cost. By taking the rehabilitation service beyond the hospital process, it allows patients to be treated in a comfortable and familiar environment. Intensive exercise programs such as the LSVT-BIG protocol impose a significant time and economic burden on patients, and there are limitations on access to the clinical setting and the practical applicability of the treatment. It is thought that these limitations can be eliminated by using the telerehabilitation method in practice. It has been reported that the LSVT-BIG protocol with telerehabilitation is a viable method with image-based video conferencing systems. The study by Fırat et al. showed that the LSVT-BIG protocol applied on the basis of telerehabilitation in Parkinson's patients gave positive results on quality of life, motor and non-motor symptoms. However, this study has some limitations such as the absence of a control group, not questioning patient satisfaction, and a small number of participants.

It is important to examine the effects of the LSVT-BIG protocol, which has been encountered in rare studies in the literature, on the motor symptoms of Parkinson's disease, since it is a current treatment approach. Few of these rare studies have used the telerehabilitation method despite the advantages it provides. In this direction, this study was planned to examine the effect of LSVT-BIG protocol applied on the basis of telerehabilitation on balance, gait, fatigue and quality of life in Parkinson's patients.

Thirty-four Parkinson's patients will be included in the study. After the first evaluation, the patients included in the study will be divided into two groups, defined as the experimental and control groups, by randomization method. The telerehabilitation-based LSVT-BIG protocol will be applied to the experimental group for four weeks, four times a week and each session for one hour, accompanied by a physiotherapist and with one-on-one participation. The control group will not be included in any physiotherapy and rehabilitation practices in addition to their basic medical treatments during this period. At the end of four weeks, a final evaluation will be made for both groups. Evaluation data will be collected from patients through face-to-face evaluation methods, questionnaires and scales.

Demographic characteristics of the patients (gender, age, height, body weight, body mass index, duration of the disease, dominant side, occupation, marital status, history, family history and medications used), Hoehn Yahr Stage and UPDRS Score will be recorded. Activity-Specific Balance Confidence Scale and Berg Balance Scale will be used for balance assessment. In addition, one-leg standing test will be applied for the evaluation of static balance and the four-step square test will be applied for the evaluation of dynamic balance. For gait assessment, Dynamic Gait Index and Figure of 8 Walk Test will be applied. Parkinson's Fatigue Scale-16 will be used for fatigue assessment and Parkinson's Disease Questionnaire-8 will be used for quality of life assessment. Telehealth Satisfaction Questionnaire will be applied in order to evaluate the satisfaction of the patient with the physiotherapy and rehabilitation approach applied to the experimental group.

The data obtained will be analyzed using the "Statistical Package for Social Sciences (SPSS)" statistical program.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey, 35565
    • Bakircay University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Have had Parkinson's Disease
• Grade 1-3 on the Hoehn-Yahr Scale
• Stability of drug therapy taken in the last month
• Being in the "ten" period of the patients
• Volunteer to participate in the study

Exclusion Criteria:

• Having other neurological, cardiovascular, or orthopedic disorder that may impair mobility have serious hearing and vision problems
• Having an additional neurological or psychiatric illness
• Not having the appropriate equipment for telerehabilitation sessions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Patients with Parkinson's Disease who were in the control group did not receive any interventional application.
Experimental: Exercise Group (LSVT-Big protocol); Patients with Parkinson's disease who were in the exercise group have completed a four-week supervised aerobic exercise protocol via Tele-rehabilitation.	Other: LSVT-BIG Group via Telerehabilitation; An aerobic supervised exercise protocol was implemented four times a week for four weeks in LSVT-BIG Group via a Tele-rehabilitation model.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Assessment	Patients' balance was assessed with Berg Balance Scale	4 weeks
Four Step Square Test	Four Step Square Test was used to assess patients' balance.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic data form	Information were gathered via a simple data form.	4 weeks
Dynamic gait index evaluation	Patients' walking capabilities were evaluated via "Dynamic walking index "	4 weeks
Assesment of quality of life	Patients' quality of life was assessed with PQOL-8 questionnaire.Minimum and maximum scores are between 1 and 29,respectively.	4 weeks
Fatigue assessment	Patients' fatigue level was assessed with Parkinson Fatigue Questionnaire.Minimum and maximum scores are between 16 and 80,respectively.	4 weeks
Assessment of the severity of Parkinson's disease	Patients' fatigue level was assessed with Unified Parkinson's Disease Rating Scale (UPDRS)	4 weeks

Collaborators and Investigators

• Sponsor: Izmir Bakircay University
• Investigators: Study Director: Alper Tuğral, Ph.D., Izmir Bakircay University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Actual): September 15, 2023
• Study Completion (Actual): October 15, 2023

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Balance; Quality of Life; Gait; Fatigue; Parkinson's Disease; Telehealth; Telerehabilitation; LSVT-BIG
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Fatigue; Parkinson Disease
• Other Study ID Numbers: IZBU-"PEKMEZCIZEYNEPULKU"-0001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No