The Effectiveness of LSVT-BIG Training in Improving Balance and Gait in Parkinson's Patients

August 2, 2023 updated by: Sefa Eldemir, Gazi University

Investigation of the Effects of Clinical Based LSVT-BIG Training and Home Based LSVT-BIG Training on Balance and Gait in Parkinson's Patients

Parkinson's disease (PD) is a chronic, progressive disease that causes motor and non-motor symptoms due to dopaminergic neuron loss. Today, the treatment of PD in addition to optimal medical and surgical treatments, physiotherapy and rehabilitation approaches have an important place in the treatment. Recently, it has been stated that intensive rehabilitation interventions in the field of physiotherapy and rehabilitation can be more effective than traditional rehabilitation approaches. Lee Silverman VoiceTreatment- BIG (LSVT-BIG) is a high-intensity exercise model aimed at improving bradykinesia and hypokinesia in PD. There are many studies showing improvements in balance, walking, motor performance, reaching ability, postural control, quality of life and cognitive status after LSVT-BIG training in PD. However, it is seen that there is no study investigating the effect of LSVT-BIG training directly by applying it as a home program. For this reason, there is a need for studies investigating whether this intensive treatment method can be an alternative to the clinical environment by applying it as a home program.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is planned as a randomized control trial. Patients will be randomly divided into two groups a clinical group and a home group. The clinical group will be received LSVT-BIG training four times a week for four weeks in the clinic. The home group will be received LSVT-BIG training two times a week for four weeks at the home and two times a week for four weeks at the clinical.

All assessments will be done before and after the 4-week intervention program or waiting period. The demographic characteristics of the participants initially will be taken. The outcome measures are balance and gait assessments.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-80 years of age
  • Having diagnosed with "Parkinson's Disease" by a specialist physician
  • Having between 1-3 stages according to the Hoehn and Yahr Scale
  • Mini-Mental Test score more than or equal 24

Exclusion Criteria:

- Any orthopedic, vision, hearing, cardiovascular, or perception problems that may affect the research results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clinical Group
This group will receive clinical-based LSVT-BIG training
Other: Exercise
Both groups will receive exercise-based training
Active Comparator: Home Group
This group will receive home-based LSVT-BIG training
Other: Exercise
Both groups will receive exercise-based training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Static Balance- Baseline
Time Frame: Assessment will be conducted before the intervention.
Assessment will be made with the Biodex Balance System
Assessment will be conducted before the intervention.
Static Balance- Post intervention
Time Frame: Assessment will be conducted immediately after the intervention.
Assessment will be made with the Biodex Balance System
Assessment will be conducted immediately after the intervention.
Gait speed- Baseline
Time Frame: Assessment will be conducted before the intervention.
Assessment will be made with the BTS G-WALK, (BTS SpA, Via della Croce Rossa, 11 Padova, Italy;SN: 0213- 0378) during gait
Assessment will be conducted before the intervention.
Gait speed- Post intervention
Time Frame: Assessment will be conducted immediately after the intervention.
Assessment will be made with the BTS G-WALK, (BTS SpA, Via della Croce Rossa, 11 Padova, Italy;SN: 0213- 0378) during gait
Assessment will be conducted immediately after the intervention.
Gait cadence- Baseline
Time Frame: Assessment will be conducted before the intervention.
Assessment will be made with the BTS G-WALK, (BTS SpA, Via della Croce Rossa, 11 Padova, Italy;SN: 0213- 0378) during gait
Assessment will be conducted before the intervention.
Gait cadence- Post intervention
Time Frame: Assessment will be conducted immediately after the intervention.
Assessment will be made with the BTS G-WALK, (BTS SpA, Via della Croce Rossa, 11 Padova, Italy;SN: 0213- 0378) during gait
Assessment will be conducted immediately after the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

Investigators

  • Study Director: Arzu Güçlü-Gündüz, PT, PhD., PROFESSOR

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2022

Primary Completion (Actual)

March 30, 2023

Study Completion (Actual)

July 22, 2023

Study Registration Dates

First Submitted

August 24, 2022

First Submitted That Met QC Criteria

August 25, 2022

First Posted (Actual)

August 30, 2022

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3- PD-LSWT-Trainig

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make PD data but when the statistical analysis of all data is made, all results will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

Clinical Trials on Exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe