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CTRI Number  CTRI/2025/07/091743 [Registered on: 25/07/2025] Trial Registered Prospectively
Last Modified On: 24/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study on Diabetic Neuropathy Patients to Improve Balance and Walking using exercise protocol 
Scientific Title of Study   Effectiveness Of Lee Silverman Voice Treatment (LSVT) BIG In Improving Balance And Gait In Patients With Diabetic Neuropathy In Dervan: 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  Dr Maansi Patel  
Designation  Post Graduate Resident 
Affiliation  B.K.L Walawalkar College of Physiotherapy Kasarwadi, Sawarde, 
Address  B.K.L Walawalkar College of Physiotherapy Kasarwadi, Sawarde, Tal- Chiplun, Dist-Ratanagari ,415606 MaharashtraUniversity of Health Sciences, Nashik

Ratnagiri
MAHARASHTRA
415606
India 
Phone  7744026208  
Fax    
Email  maansi.patel10@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Thaiba Reinai 
Designation  HOD  
Affiliation  B.K.L Walawalkar College of Physiotherapy Kasarwadi, Sawarde, 
Address  B.K.L Walawalkar College of Physiotherapy Kasarwadi, Sawarde, Tal- Chiplun, Dist-Ratanagari ,415606 MaharashtraUniversity of Health Sciences, Nashik

Ratnagiri
MAHARASHTRA
415606
India 
Phone  9582971604  
Fax    
Email  reinaithaiba@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Maansi Patel 
Designation  Post Graduate Resident 
Affiliation  B.K.L Walawalkar College of Physiotherapy Kasarwadi, Sawarde, 
Address  B.K.L Walawalkar College of Physiotherapy Kasarwadi, Sawarde, Tal- Chiplun, Dist-Ratanagari ,415606 MaharashtraUniversity of Health Sciences, Nashik

Ratnagiri
MAHARASHTRA
415606
India 
Phone  9582971604  
Fax    
Email  maansi.patel10@gmail.com  
 
Source of Monetary or Material Support  
B.K.L Walawalkar College of Physiotherapy Kasarwadi, Sawarde, Tal- Chiplun, Dist-Ratanagari ,415606 MaharashtraUniversity of Health Sciences, Nashik 
 
Primary Sponsor  
Name  Dr Maansi Patel 
Address  B.K.L Walawalkar College of Physiotherapy Kasarwadi, Sawarde, Tal- Chiplun, Dist-Ratanagari ,415606 MaharashtraUniversity of Health Sciences, Nashik 
Type of Sponsor  Other [Self] 
 
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 Maansi patel  B.K.L Walawalkar Rural Medical College and Hospital, Diagnostic & Research Center  OPD NO 9, Second Floor, Physiotherapy Department, B.K.L Walawalkar Hospital, Kasarwadi, Sawarde, Tal- Chiplun, Dist-Ratanagari, 415606 Maharashtra University of Health Sciences, Nashik
Ratnagiri
MAHARASHTRA 
7744026208

maansi.patel10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
B.K.L Walawalkar College of Physiotherapy (MUHS) Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A- LSVT BIG  Forward big steps (16 repetitions; 8 reps. each leg) Sideways big steps (16 repetitions; 8 reps. each leg) Backward big steps (16 repetitions; 8 repetitions each leg) Forward big rock and reach (20 repetitions; 10 repetitions each) Backward rock and reach (16 repetitions; 8 repetitions each leg)Sideways big rock and reach (20 repetitions; 10 repetitions each side).Floor to ceiling (10 repetitions) Sit to stand(10 repetitions)Big walking (each leg) 
Comparator Agent  Group B- Conventional Exercise  Sit to stand (5 times) Standing with shifting weight anteriorly,posteriorly, and sideway (5 times for each direction)Functional reach sideway and anterior (5 times for each direction) Standing on toes (5-20 seconds, 5 times) Standing on heels (5-20 seconds, 5 times) Step up & step down (10-15 times) One leg stance (5-20 seconds, 5 times) Tandem stance (5-20 seconds, 5 times)  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  • Diabetes diagnosed by physician
• Both female and male
• Age group- 40 to 70 years
• Mentally stable
• Walking independently without walking aids 
 
ExclusionCriteria 
Details  Foot ulceration/infection/amputation
Severe retinopathy/ Non operated Cataract
Non-neuropathy related orthopedic, surgical or medical conditions
Alcohol abuse
Vestibular dysfunction
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
• Berg Balance Scale (BBS)
• 10-meter walk test (10mWT)
 
Baseline and 4 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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)   20/08/2025 
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="1"
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   Title - Effectiveness of Lee Silverman Voice Treatment (LSVT) BIG in Improving Balance and Gait in Patients with Diabetic Neuropathy in Dervan: A Randomized Controlled Trial


INTRODUCTION

Approximately 830 million people, worldwide suffer from diabetes, making it a serious health issue. One of its most complications is Diabetic neuropathy, which affects over 50% of people with diabetes. In India, diabetic neuropathy is common, however, its occurrence differs considerably across multiple populations, with estimates ranging from 9.6% to 78%.

Diabetic neuropathy (DN) condition is one of the leading causes of falls in many people with neurological conditions, considerably affecting balance and gait. Lower limb proprioception, cutaneous sensation and muscle stretch reflexes are greatly affected by this condition. These functions are necessary for detecting balance problems and initiating corrective actions. Therefore, such population are at greater risk of balance problems and falls.

The progression of DPN can have a significant impact on a person’s daily life. In the early stages the symptoms may be mild or barely noticeable. But, as the condition advances, people often struggle with sensory and motor impairments affecting their mobility and overall well-being. 

Physiotherapy plays an important role in controlling DN by addressing issues like neuropathic pain, muscle weakness, gait instability, and balance issues. Balance issues due to proprioceptive deficiencies and weak ankle muscles are frequently observed. To enhance postural control and coordination, multisensory training, single-leg stance exercises, and weight-shifting drills are observed to be beneficial.

In a randomized clinical trial, Khashayar(2015) compared LSVT BIG with a general exercise program and found significant improvements in balance, gait speed, and postural stability in PD patients. Enhanced weight-shifting ability, increased stride length, and improved reaction times, were also observed all of which are crucial for preventing falls. In conclusion, LSVT BIG therapy proved to be an effective intervention for managing balance deficits in PD, helping individuals reduce fall risk, improve mobility, and maintain independence.


AIM OF THE STUDY- 

To evaluate the effectiveness of LSVT BIG in improving balance and gait in patients with diabetic neuropathy.
 
OBJECTIVE OF THE STUDY –
To compare the effectiveness of LSVT BIG and Conventional Physiotherapy on balance and gait among DN patients.


NEED OF THE STUDY

LSVT BIG is a high-amplitude movement therapy originally developed to improve motor function, balance, and gait. Given the similarities between Parkinsonian gait disturbances and the gait impairments seen in diabetic neuropathy, such as reduced stride length, slow walking speed, and postural instability, LSVT BIG may offer potential benefits for improving motor control and balance in these patients.

Unlike traditional rehabilitation, which often focuses on isolated muscle groups or balance strategies, LSVT BIG encourages whole-body movements that may contribute to improvements in coordination, step length, and walking speed.

This study can prove essential to evaluate whether LSVT BIG exercises can serve as an effective physiotherapy intervention for improving balance and gait in patients with DN. Findings could contribute to clinical guidelines for DN rehabilitation, helping develop targeted interventions to improve patient outcomes. 

Inclusion criteria:
Diabetes diagnosed by physician
Age group- 40 to 70 years
Toronto Clinical Scoring System > 6 /19
Walking independently without walking aids

Exclusion criteria:
Foot ulceration/infection/amputation
Severe retinopathy/ Non operated Cataract
Non-neuropathy related orthopedic, surgical or medical conditions 
Alcohol abuse
Vestibular dysfunction


METHODOLOGY:


Study design: Experimental Study: RCT
Study population: Diabetic Neuropathy
Study setting: Physiotherapy OPD (Rural Medical Hospital)
Study duration: 18 Months.
Sampling method: Purposive sampling
Allocation concealment method: SNOSE technique
Sample size: A total of 46 subjects will be taken.

Outcome measures:
Berg Balance Scale (BBS)
10-meter walk test (10mWT) 
Materials
128 Hz Tuning Fork
Reflex Hammer
Test tubes
Measuring Tape
Chair
Stopwatch
Marker Cones/ Tape


CLINICAL IMPLICATION-

LSVT BIG can be incorporated into standard physiotherapy regimens for diabetic neuropathy to improve balance and gait.
Improved postural control and gait may reduce the risk of falls in patients with diabetic neuropathy, especially in the elderly population.
The study provides clinicians with evidence to justify the use of LSVT BIG beyond its traditional Parkinson’s population.


 
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