The Effectiveness of LSVT-BIG Training in Improving Balance and Gait in Parkinson's Patients
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, LSVT-BIG Training, Home Based Exercise, Balance, Walking
Eligibility Criteria
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
Sites / Locations
- Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Clinical Group
Home Group
Arm Description
This group will receive clinical-based LSVT-BIG training
This group will receive home-based LSVT-BIG training
Outcomes
Primary Outcome Measures
Static Balance- Baseline
Assessment will be made with the Biodex Balance System
Static Balance- Post intervention
Assessment will be made with the Biodex Balance System
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
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
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05520541
Brief Title
The Effectiveness of LSVT-BIG Training in Improving Balance and Gait in Parkinson's Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
July 22, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, LSVT-BIG Training, Home Based Exercise, Balance, Walking
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups as clinical group and home group
Masking
ParticipantOutcomes Assessor
Masking Description
Double (Participant, Outcomes Assessor)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clinical Group
Arm Type
Experimental
Arm Description
This group will receive clinical-based LSVT-BIG training
Arm Title
Home Group
Arm Type
Active Comparator
Arm Description
This group will receive home-based LSVT-BIG training
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Both groups will receive exercise-based training
Primary Outcome Measure Information:
Title
Static Balance- Baseline
Description
Assessment will be made with the Biodex Balance System
Time Frame
Assessment will be conducted before the intervention.
Title
Static Balance- Post intervention
Description
Assessment will be made with the Biodex Balance System
Time Frame
Assessment will be conducted immediately after the intervention.
Title
Gait speed- Baseline
Description
Assessment will be made with the BTS G-WALK, (BTS SpA, Via della Croce Rossa, 11 Padova, Italy;SN: 0213- 0378) during gait
Time Frame
Assessment will be conducted before the intervention.
Title
Gait speed- Post intervention
Description
Assessment will be made with the BTS G-WALK, (BTS SpA, Via della Croce Rossa, 11 Padova, Italy;SN: 0213- 0378) during gait
Time Frame
Assessment will be conducted immediately after the intervention.
Title
Gait cadence- Baseline
Description
Assessment will be made with the BTS G-WALK, (BTS SpA, Via della Croce Rossa, 11 Padova, Italy;SN: 0213- 0378) during gait
Time Frame
Assessment will be conducted before the intervention.
Title
Gait cadence- Post intervention
Description
Assessment will be made with the BTS G-WALK, (BTS SpA, Via della Croce Rossa, 11 Padova, Italy;SN: 0213- 0378) during gait
Time Frame
Assessment will be conducted immediately after the intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arzu Güçlü-Gündüz, PT, PhD.
Organizational Affiliation
Professor
Official's Role
Study Director
Facility Information:
Facility Name
Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
City
Ankara
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
28331638
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 2017 Feb 26.
Results Reference
result
PubMed Identifier
34125001
Citation
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 report. Physiother Theory Pract. 2022 Nov;38(13):3159-3168. doi: 10.1080/09593985.2021.1938304. Epub 2021 Jun 14.
Results Reference
result
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The Effectiveness of LSVT-BIG Training in Improving Balance and Gait in Parkinson's Patients
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