CTRI/2025/04/084583 [Registered on: 11/04/2025] Trial Registered Prospectively
Last Modified On:
22/03/2025
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Physiotherapy (Not Including YOGA)
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
To see the Effect of Lee Silverman Voice Treatment BIG on walking and movement in people with Parkinsons Disease
Scientific Title of Study
Effect of Lee-Silverman voice treatment BIG on gait balance and mobility skills in people with parkinson Disease
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Sanjana Chandan
Designation
MPT Student
Affiliation
Sunandan Divatia School Of Science
Address
Department of physiotherapy ground floor nanavati Max Super Speciality hospital S v road Vile parle (west)
Mumbai MAHARASHTRA 400057 India
Phone
9920528069
Fax
Email
SANJANA.CHANDAN043@nmims.in
Details of Contact Person Scientific Query
Name
DrSabha Thaver
Designation
Assistant professor- physiotherapy
Affiliation
Sunandan Divatia School Of Science
Address
Department of physiotherapy ground floor nanavati Max Super Speciality hospital S v road Vile parle (west)
Mumbai MAHARASHTRA 400056 India
Phone
9820691076
Fax
Email
Sabah.thaver@nmims.edu
Details of Contact Person Public Query
Name
DrSabha Thaver
Designation
Assistant professor- physiotherapy
Affiliation
Sunandan Divatia School Of Science
Address
Department of physiotherapy ground floor nanavati Max Super Speciality hospital S v road Vile parle (west)
Mumbai MAHARASHTRA 400056 India
Phone
9820691076
Fax
Email
Sabah.thaver@nmims.edu
Source of Monetary or Material Support
Department of Physiotherapy ,ground floor, Nanavati Max Super Specality Hospital, SV Road,
Vileparle west,Mumbai-400056
Primary Sponsor
Name
SANJANA CHANDAN
Address
Department of physiotherapy ground floor nanavati Max Super Speciality hospital S v road Vile parle (west)
Type of Sponsor
Other [NIL]
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Sabah Thaver
Nanavati Max Super Specialty Hospital
Department of
physiotherapy, Ground Floor,
SV Road, Vileparle west
Mumbai
MAHARASHTRA Mumbai (Suburban) MAHARASHTRA
02261347560
physiodept.nanavati@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Nanavati Max Super Speciality Hospital
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: G20||Parkinsons disease,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Conventional Protocol for Balance, Gait and Mobility
It is a 4 week intervention with 4 sessions per week on consecutive days with a total of 16 sessions
Intervention
Lee Silverman Voice Treatment (LSVT)-BIG
4 week intervention with 4 sessions per week on consecutive days with total - 16 sessions
Inclusion Criteria
Age From
40.00 Year(s)
Age To
90.00 Year(s)
Gender
Both
Details
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
ExclusionCriteria
Details
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
Method of Generating Random Sequence
Coin toss, Lottery, toss of dice, shuffling cards etc
Total Sample Size="60" Sample Size from India="60" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 2
Date of First Enrollment (India)
22/04/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
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