Clinical trial NCT05520541: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
LSVT-BIG Training
Home Based Exercise
Balance
Walking
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups as clinical group and home group
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Static Balance- Baseline
timeFrame: Assessment will be conducted before the intervention.
measure: Static Balance- Post intervention
timeFrame: Assessment will be conducted immediately after the intervention.
measure: Gait speed- Baseline
timeFrame: Assessment will be conducted before the intervention.
measure: Gait speed- Post intervention
timeFrame: Assessment will be conducted immediately after the intervention.
measure: Gait cadence- Baseline
timeFrame: Assessment will be conducted before the intervention.
measure: Gait cadence- Post intervention
timeFrame: Assessment will be conducted immediately after the intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Study officials:
affiliation: Professor
name: Arzu Güçlü-Gündüz, PT, PhD.
role: STUDY_DIRECTOR
References:
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.
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.