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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05520541
• Other study ID #: 3- PD-LSWT-Trainig
• Status: Completed
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: July 22, 2023

Study information

• Verified date: August 2023
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 22, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Exercise
Both groups will receive exercise-based training

Locations

Country	Name	City	State
Turkey	Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Hirakawa Y, Takeda K, Koyama S, Naoi Y, Matsushita T, Nagai T, Motoya I, Sakurai H, Kanada Y, Kawamura N, Kawamura M, Tanabe S. Effect of Lee Silverman Voice Treatment (LSVT)(R) BIG on motor symptoms in a patient with severe Parkinson's disease: a case re — View Citation

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 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Static Balance- Baseline	Assessment will be made with the Biodex Balance System	Assessment will be conducted before the intervention.
Primary	Static Balance- Post intervention	Assessment will be made with the Biodex Balance System	Assessment will be conducted immediately after the intervention.
Primary	Gait speed- Baseline	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.
Primary	Gait speed- Post 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.
Primary	Gait cadence- Baseline	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.
Primary	Gait cadence- Post 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.