Effect of Lee-Silverman voice treatment BIG on gait balance and mobility skills in people with parkinson Disease
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Tinetti Performance Oriented Mobility Assessment
研究概览
简要总结
INTRODUCTION Parkinson’s Disease (PD) is a progressive neurodegenerative disorder characterized by tremors, rigidity, bradykinesia, and postural instability, caused by the loss of dopaminergic neurons in the substantia nigra. It affects 1% of people over 60, with prevalence expected to rise significantly. The Hoehn and Yahr scale assesses disease progression, while rehabilitation, including conventional physiotherapy and LSVT-BIG, plays a crucial role in managing motor dysfunctions like gait and balance issues. LSVT-BIG is an intensive movement therapy focusing on amplitude training, improving mobility, reducing falls, and enhancing quality of life. Research suggests LSVT-BIG outperforms traditional physiotherapy in motor symptom improvement, emphasizing its role in PD rehabilitation.
RATIONALE The study focuses on addressing Gait, Balance, and Mobility Dysfunction, which are the most common motor impairments in Parkinson’s Disease (PD). While conventional physiotherapy has been widely researched, newer modalities like LSVT-BIG are being explored in India. LSVT-BIG incorporates Neurology, Physiology, Muscle Training, Neuropsychology, and Motor Learning to enhance movement amplitude and counteract bradykinesia. Further research is needed to evaluate its effects on mobility, gait, and balance and compare its effectiveness with conventional physiotherapy in outpatient settings. Understanding these aspects can help improve rehabilitation strategies for PD patients, enhancing their quality of life and functional independence.
AIM The aim of this study is to assess the effect of Lee Silverman Voice Treatment-BIG (LSVT-BIG) on gait, balance, and mobility skills in individuals with Parkinson’s Disease.
OBJECTIVIES objectives include evaluating changes in gait, balance, and mobility using LSVT-BIG and conventional physiotherapy and comparing the effectiveness of both approaches
OUTCOME MEASURE
Tinetti POMA (Performance-Oriented Mobility Assessment) - to assess an individual’s balance and gait abilities.
10-meter walk test - to assess a person’s walking speed by measuring the time it takes them to walk a distance of 10 meters.
Timed Up and Go" (TUG) test - to assess a person’s functional mobility and balance.
Dynamic Gait Index - assesses an individual’s ability to modify balance while walking in the presence of external demands.
PROTOCOL
LSVT-BIG
The first half of exercises (30 minutes or more) encompass whole body exercises.
The second half (30 minutes or less) consists of functional, goal directed activities of daily living.
The schedule for the LSVT-BIG program is 4 consecutive days a week for 4 weeks, which results in 16 sessions in one month.
Task Repetitions vary from 8-16 repetitions, and 5 repetitions for functional movements.
Each treatment session lasts 60 minutes.
Homework – Practice daily exercises at home – on treatment and non-treatment days and incorporation of Functional Component Movements (eg: Walking – BIG) in activities of daily living. Homework book will be provided to make the patient accountable
CONVENTIONAL PROTOCOL
Patients will begin balance exercises with maximum support which will be followed by gradual weekly progressions.
Exercises will take place in one on one sessions
4 sessions will take place every week across 4 weeks with 16 sessions overall.
Homework –Patients will be asked to practice functional exercises (eg – walking) every day at home on treatment and non- treatment days. Homework book will be provided to make the patient accountable
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with parkinsons disease between stage 1 to stage 3 on modified Hoehn and Yahr scale.
- •Patients who are on stable medications 4 weeks prior to and during the study.
排除标准
- •Any orthopedic, vision, hearing, cardiovascular or perception problems that may affect the research results.
- •Unstable Blood Pressure, Osteoporosis and/or other co-morbodities that affects the patients ability to engage in the LSVT-BIG protocol for one hour.
结局指标
主要结局
Tinetti Performance Oriented Mobility Assessment
时间窗: Baseline and Post 4 weeks of intervention
(POMA)
时间窗: Baseline and Post 4 weeks of intervention
次要结局
- Timed 10-Meter Walk Test
- DYNAMIC GAIT INDEX
- Timed Up and Go Test(Baseline and Post 4 weeks of intervention)
研究者
Sanjana Chandan
Sunandan Divatia School Of Science