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

NCT ID: NCT05520541

Last Updated: 2023-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-15

Study Completion Date

2023-07-22

Brief Summary

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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

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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.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups as clinical group and home group
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Double (Participant, Outcomes Assessor)

Study Groups

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Clinical Group

This group will receive clinical-based LSVT-BIG training

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

Both groups will receive exercise-based training

Home Group

This group will receive home-based LSVT-BIG training

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type OTHER

Both groups will receive exercise-based training

Interventions

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Exercise

Both groups will receive exercise-based training

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Sefa Eldemir

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arzu Güçlü-Gündüz, PT, PhD.

Role: STUDY_DIRECTOR

Professor

Locations

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Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 28331638 (View on PubMed)

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.

Reference Type RESULT
PMID: 34125001 (View on PubMed)

Other Identifiers

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3- PD-LSWT-Trainig

Identifier Type: -

Identifier Source: org_study_id

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