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CTRI Number  CTRI/2026/01/100982 [Registered on: 13/01/2026] Trial Registered Prospectively
Last Modified On: 13/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of LSVT big protocol on memmory cognition endurance gait speed and balance in patients with Parkinsons disease  
Scientific Title of Study   Effect of LSVT big protocol on memory cognition endurance gait speed and balance in patients with Parkinsons disease A Randomized Controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ketan Kantilal Bagul 
Designation  Undergraduatestudent 
Affiliation  Dr APJ abdul kalam college of physiotherapy pravara institute of sciences 
Address  Dr APJ abdul kalam college of physiotherapy pravara institute of medical sciences loni Tal Rahata Dist Ahamadnagar Maharshtra 413736 India

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8329726222  
Fax    
Email  ketanbagul396@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ketan Kantilal Bagul 
Designation  Undergraduatestudent 
Affiliation  Dr APJ abdul kalam college of physiotherapy pravara institute of sciences 
Address  Dr APJ abdul kalam college of physiotherapy pravara institute of sciences loni Ahmednagar Maharshtra 413736 India

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8329726222  
Fax    
Email  ketanbagul396@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shyam Kurapati 
Designation  Proffesor and Head of department 
Affiliation  Dr APJ abdul kalam college of physiotherapy pravara institute of sciences 
Address  Dr APJ abdul kalam college of physiotherapy pravara institute of sciences loni Ahmednagar Maharshtra 413736 India

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8978438484  
Fax    
Email  kurapatishyam82@gmail.com  
 
Source of Monetary or Material Support  
Neurophysiotherapy Department Dr A P J Abdul Kalam College of Physiotherapy PIMS (DU) loni Tal rahata Dist Ahemadnagar Maharastra 413736 
 
Primary Sponsor  
Name  Nil 
Address  NIL 
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 
Ketan Kantilal Bagul  Dr APJ Abdul Kalam College of Physiotherapy, Pravara Institute of Medical Sciences  OPD NO-303 Third floor, Neuro Physiotherapy Department Loni Taluka Rahata District Ahmadnagar MAHARASHTRA
Ahmadnagar
MAHARASHTRA 		 8329726222

keanbagul369@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Ethical Committee  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 THERAPY  Exercise 1 8 repetitions sustain stretch floor to ceiling Exercise 2 8 repetitions sustain big stretch side to side Exercise 2 16 repetitions step forward 8 repetitions each leg Exercise 2 16 repetitions step sideways 8 repetitions each side Exercise 3 16 repetitions big step backward 8 repetitions each leg Exercise 4 20 repetitions forward and reach 10 repetitions each side Exercise 5 20 repetitions sideways and reach 10 repetitions each side 
Intervention  LEE SILVERMAN VOICE TREATMENT BIG  Exercise 1 8 repetitions sustain big stretch floor to ceiling Exercise 2 8 repetitions sustain big stretch side to side Exercise 3 16 repetitions big step forward 8 repetitions each leg Exercise 4 16 repetitions big step sideways 8 repetitions each side Exercise 5 16 repetitions big step backward 8 repetitions each leg Exercise 6 repetitions forward big rock and reach 10 repetitions each side Exercise 7 20 repetitions sideways big rock and reach 10 repetitions each side Patient identifies 5 movements he or she does in functional everyday living example sit-to-stand Clinician and patient select one simple component of each of these movements There are 5 repetitions for each of the component movements Do your movement with the same effort bigness that you do during daily exercises  
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Age between 50-80 years
Both male and female patient dignosed with parkinsons
Assesment and staging according to H and Y scale
Score of MoCA scale should less than 26 (A final total score of 26 and above is considered normal.)
 
 
ExclusionCriteria 
Details  Recent injuries
Any neurological or systemic disease
Participants not on regular basis
Patient with deformity
Patient with having score more than 26 in MoCA scale
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the memory cognition endurance and gait speed balance

 		 Baseline AND WEEK 4 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   25/01/2026 
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="1"
Months="0"
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  

LSVT Big Protocol The LSVT Big protocol is a physical therapy program that emphasizes large, purposeful movements to improve motor function in patients with PD. It is based on the principle of neuroplasticity, which suggests that intensive practice of motor skills can help the brain form new pathways and improve function. LSVT Big is primarily designed to improve motor symptoms like gait and balance but may also have effects on endurance due to the increased level of physical activity

Conventional Therapy Conventional therapy usually refers to standard approaches used in physical occupational or speech therapy to manage PD symptoms This can include strength training balance exercises aerobic activities or cognitive rehabilitation Adding LSVT Big to conventional therapy may enhance overall outcomes combining the benefits of motor improvement with cognitive and functional exercises

Cognitive and Memory Function in PD Memory and cognitive deficits in PD particularly in the later stages can have a profound impact on daily functioning Research into the potential cognitive benefits of therapies like LSVT Big is important because treatments that improve motor function may have secondary benefits for cognition through enhanced physical activity reduced anxiety and improved mood Additionally the attention required for large intentional movements may improve aspects of executive function which is often impaired in PD Endurance Patients with PD often experience a decline in endurance due to bradykinesia slowness of movement and muscle rigidity Combining LSVT Big with conventional therapies that focus on endurance eg aerobic exercises might lead to greater improvements in cardiovascular fitness mobility and energy levels

Gait Speed and Balance Impaired gait speed and balance are hallmark symptoms of PD leading to an increased risk of falls and decreased independence LSVT Big has been shown to improve gait speed by focusing on larger more exaggerated movements which helps in overcoming some of the motor limitations of PD Balance training is also crucial for preventing falls and combining LSVT Big with other balance focused interventions in conventional therapy could lead to even more significant improvements

Need for This Study While the individual effects of LSVT Big on motor symptoms like gait and balance are well-documented there is less research into its impact on cognitive functions memory attention and executive function and endurance especially when combined with other conventional therapy approaches Such a study would have to done 

Establish comprehensive treatment protocols A combined approach can address both motor and non motor symptoms Provide personalized treatment plans Understanding the full scope of LSVT Bigs benefits can help clinicians tailor treatments Improve quality of life Enhancing cognition memory endurance gait speed and balance would allow PD patients to maintain a higher level of independence Guide future interventions This study would provide evidence for whether combining LSVT Big with conventional therapy could be more effective than using either treatment alone In summary a study on the combined effects of LSVT Big protocol and conventional therapy on memory cognition endurance gait speed and balance in Parkinsons disease is crucial to advance treatment protocols and improve the overall quality of life for PD patients

MATERIAL AND METHODOLOGY Source of Data will be collected from In Patient Department Pravara Medical Trust Loni and Arihant neuro centre Nashik  Method of collection of data Type of Data Quantitative Study Design Randomised Control Trail Study Setting InPatient department of Medicine and Department of Neuro Physiotherapy at Dr APJAK College of Physiotherapy PIMS Loni Sample size 20 participants Patient diagnosed with Parkinson  Sampling Method Coin toss Lottery toss of dice shuffling cards etc Study Duration 1 years. Material to be used are Consent form MoCA scale  6 min walk test  10 meter walk test  Berg Balance Scale  and assess the stage of parkinsons using H and Y scale

Group A  Convetional

Exercise 1 8 repetitions sustain biq stretch floor to ceiling Exercise 2 8 repetitions sustain big stretch side to side

Exercise 2 16 repetitions big step forward 8 repetitions each leg Exercise 2 16 repetitions big step sideways 8 repetitions each side

Exercise 3 16 repetitions big step backward 8 repetitions each leg

Exercise 4 20 repetitions forward big rock and reach 10 repetitions each side

Exercise 5 20 repetitions sideways big rock and reach 10 repetitions each side

Group B  Experimental

Exercise 1 8 repetitions sustain big stretch floor to ceiling

Exercise 2 8 repetitions sustain big stretch side to side

Exercise 1 16 repetitions big step forward 8 repetitions each leg

Exercise 2 16 repetitions big step sideways 8 repetitions each side

Exercise 3 16 repetitions big step backward 8 repetitions each leg

Exercise 4 20 repetitions, forward big rock and reach 10 repetitions each side

Exercise 5 20 repetitions, sideways big rock and reach 10 repetitions each side

Patient identifies 5 movements he or she does in functional everyday living eg, sit to stand Clinician and patient select one simple component of each of these movements There are 5 repetitions for each of the component movements Do your movement with the same effort bigness that you do during daily exercises
 
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