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CTRI Number  CTRI/2024/08/073031 [Registered on: 28/08/2024] Trial Registered Prospectively
Last Modified On: 27/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   To improve balance and quality of life in parkinsonism patients by giving comparitive treatment of Lee Silverman Voice Therapy BIG Exercises and Neuromuscular Exercises 
Scientific Title of Study   Comparison of Lee SilverMan Voice Therapy Big exercises and Neuromuscular Exercise Training on Balance and Quality of life among Parkinsonism 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kasireddi vanitha  
Designation  post graduate Student  
Affiliation  SRM college of physiotherapy SRM institute of science and technology 
Address  Room no PT05 5TH Floor SRM college of physiotherapy SRM institute of science and technology SRM nagar potheri Kattankulathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  7075426969  
Fax    
Email  kz0502@srmist.edu.in  
 
Details of Contact Person
Scientific Query  
Name  J Suresh 
Designation  Associate Proffesor 
Affiliation  SRM college of physiotherapy SRM institute of science and technology 
Address  Room no PT14 5TH Floor SRM college of physiotherapy SRM institute of science and technology SRM nagar potheri kattankulathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  9698642928  
Fax    
Email  sureshj@srmist.edu.in  
 
Details of Contact Person
Public Query  
Name  J Suresh 
Designation  Associate Proffesor 
Affiliation  SRM college of physiotherapy SRM institute of science and technology 
Address  Room no PT14 5TH Floor SRM college of physiotherapy SRM institute of science and technology SRM nagar potheri kattankulathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  9698642928  
Fax    
Email  sureshj@srmist.edu.in  
 
Source of Monetary or Material Support  
SRM college of physiotherapy SRM institute of science and technology SRM nagar potheri kattankulathur Tamilnadu 603203 India 
 
Primary Sponsor  
Name  SRM college of physiotherapy SRM institute of science and technology 
Address  Room no PT05 5TH Floor SRM college of physiotherapy SRM institute of science and technology SRM nagar potheri kattankulathur Kancheepuram Tamil Nadu 603203 India 
Type of Sponsor  Research institution and hospital 
 
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 kasireddi vanitha  SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE  First floor General Medicine male unit one to six and female ward unit one to four Fifth Floor Neuro medicine male and female ward unit one to four SRM Medical College Hospital And Research Centre SRM nagar potheri kattankulathur
Kancheepuram
TAMIL NADU 		 7075426969

kz0502@srmist.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Medical College Hospital And Research Centre INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G218||Other secondary parkinsonism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Lee Silverman voice therapy BIG EXERCISES   Control group will be receiving LSVT BIG EXERCISES for 16 sessions, in alternative days for 6 weeks 4 weeks exercises of LSVT BIG exercises and 2 weeks of follow exercises for balance and quality of life improvement along with conventional physiotherapy 
Intervention  NEUROMUSCULAR EXERCISE TRAINING   experimental study group will be receiving Neuromuscular exercise training which includes 5 phases of different exercises using Bosuball and swiss ball for balance and quality of life improvement in parkinsonism for 6 weeks study 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Stage 1 and 2 on modified Hoehn and Yahr scale
2 Patients who are under stable pharmacological treatment for at least 3 months for Parkinsons disease
3 Ambulatory without the use of any aid indoor
4 More than 24 on mini mental status examination scale 
 
ExclusionCriteria 
Details  1 History of other neurological or cardiopulmonary disease which interfering with the mobility of participant
Visual and Auditory problems
2 Patients whose medications or dose would need to be changed during the study
3 Mental health conditions like Alzheimer s dementia that prevents successful participation
4 Comorbidities affecting exercise abilities such as metabolic disorders (OA Hypertension)
5 History of orthopedic conditions and any previous diagnosis of vestibular dysfunction 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mini BESTest
 		 baseline
at first day
after six weeks 
 
Secondary Outcome  
Outcome  TimePoints 
short form 12 health survey questionnaire  baseline
at first day
after seven weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   13/09/2024 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   BACKGROUND Parkinsonism populations suffer from both motor and non-motor symptoms which significantly impact patients balance and overall quality of life Balance impairment is a common problem in Parkinsonism which has been addressed by various managements Due to the decline of balance in these populations there is an activity limitation and participation restriction which affects the quality of life This study compares the effectiveness of LSVT Big exercises and Neuromuscular exercise training on balance and quality of life in individuals with parkinsonism There has been Evidence of the impact of LSVT Big exercises on balance and quality of life improvement for the Parkinsonism population There is limited evidence on the impact of neuromuscular exercise training through cost effective means of delivery through exercise application on balance and quality of life in Parkinsonism
METHODS A non randomised active control arm study parallel group type of the study is experimental study and the study design is comparative study with a sample size of 30 for duration of 6 weeks and the study setting is General Medicine Male and female ward Neuro medicine male and female ward of SRM medical college hospital and research center
DISCUSSION the study will let us know the comparative effectiveness of Leesilverman voice therapy big exercise and Neuromuscular exercises to be effective in improving balance and mobility for people with Parkinsonism.
 
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