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

NCT06215898 | Completed

• 1 other identifier: IZBU-"PEKMEZCIZEYNEPULKU"-0001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

Parkinson's Disease; LSVT-BIG; Balance; Gait; Fatigue; Quality of Life; Telerehabilitation; Telehealth

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Demographic data form

  4 weeks

• Dynamic gait index evaluation

  4 weeks

• Assesment of quality of life

  4 weeks

• Fatigue assessment

  4 weeks

• Assessment of the severity of Parkinson's disease

  4 weeks

Study Arms (2)

Control Group

NO INTERVENTION

Patients with Parkinson's Disease who were in the control group did not receive any interventional application.

Exercise Group (LSVT-Big protocol)

EXPERIMENTAL

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

Interventions

LSVT-BIG Group via Telerehabilitation OTHER

An aerobic supervised exercise protocol was implemented four times a week for four weeks in LSVT-BIG Group via a Tele-rehabilitation model.

Exercise Group (LSVT-Big protocol)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Bakircay University: lead

Study Sites (1)

Bakircay University

Izmir, 35565, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease; Fatigue

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alper Tuğral, Ph.D.

  Izmir Bakircay University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Model Details: Controlled study

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 22, 2024
• Study Start: May 15, 2023
• Primary Completion: September 15, 2023
• Study Completion: October 15, 2023
• Last Updated: January 22, 2024

Record last verified: 2024-01

Locations

TU (1)