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CTRI Number  CTRI/2024/06/069372 [Registered on: 24/06/2024] Trial Registered Prospectively
Last Modified On: 04/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Strength training and Lee Silverman Voice Treatment BIG effects on balance, exercise, and fall risk in the senior population.  
Scientific Title of Study   Effectiveness of Lee Silverman Voice Treatment (LSVT) BIG and Strength Training on Balance, Physical Activity and Risk of Fall in Elderly Population. A Quasi Experimental Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SMRITY RAI 
Designation  MPT 2nd YEAR 
Affiliation  Dayananda Sagar University- College Of Physiotherapy 
Address  Devarakaggalahalli Harohalli Kanakapura Road Dt Ramanagara Karnataka 562112

Bangalore Rural
KARNATAKA
-562112
India 
Phone  9564149602  
Fax    
Email  smritychamling@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  SUNJYOTH H S 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Dayananda Sagar University- College Of Physiotherapy 
Address  Devarakaggalahalli Harohalli Kanakapura Road Dt Ramanagara Karnataka 562112

Bangalore Rural
KARNATAKA
562112
India 
Phone  8722555859  
Fax    
Email  sunjyoth-physio@dsu.edu.in  
 
Details of Contact Person
Public Query
 
Name  SUNJYOTH H S 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Dayananda Sagar University- College Of Physiotherapy 
Address  Devarakaggalahalli Harohalli Kanakapura Road Dt Ramanagara Karnataka 562112

Bangalore Rural
KARNATAKA
562112
India 
Phone  8722555859  
Fax    
Email  sunjyoth-physio@dsu.edu.in  
 
Source of Monetary or Material Support  
old age home 
SMRITY RAI 
 
Primary Sponsor  
Name  SMRITY RAI 
Address  Devarakaggalahalli Harohalli Kanakapura Road Dt Ramanagara Karnataka 562112 
Type of Sponsor  Other [other (self)] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr SARAVANAN  SEVA OLD AGE HOME   BEGUR ROAD BANGALORE
Bangalore
KARNATAKA 
7028039508

sevacharitabletrustindia@gmail.com 
DR SARAVANAN  SEVA OLD AGE HOME   seva charitable trust - Begur road Bangalore Karnataka
Bangalore
KARNATAKA 
7028039508

sevacharitabletrustindia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
DAYANANDA SAGAR UNIVERSITY  Approved 
SEVA OLD AGE HOME  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  geriatric population with mild balance impairment 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ONE GROUP STUDY  The study is a one group experimental study with 35 sample size comprising of older adults age above 65 years with mild balance impairment . aim of the study is to assess the effectiveness of LSVT Big and strength training on balance, physical activity and risk of fall in elderly population. it is a 4 weeks of experimental study with 3 days of intervention for 1 hour consisting of 45 mins of LSVT BIG training and 15 mins of strength training. consent will be taken from the participants before the study program. The screening will be done using MMSE scale for measuring level of cognition and level of balance will be measured using Berg Balance Scale. The pre intervention data will be collected using outcome measures BBS, POMA scale, TUG scale and PASE scale. Then intervention will be started and training will be given for 1 hour per session for 3 days every week for 4 weeks and home exercise program will be suggested with same exercises. After 4 weeks the post data will be taken using the same outcome measure and the data will be sent for statistical analysis to the statistician and the result will be verified 
Comparator Agent  PRE AND POST   duration of the intervention is 3 days per week for 4 weeks. 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  1 Age: Participants should be between 65-95 years old.
2 Balance impairment- Participants with a score of 40-50 in Berg balance scale .
3 Co-morbidities- Participants with additional significant health conditions.
4 Language- Participants should have the ability to understand language English and Hindi communicate effectively.
5 Physical capacity- Participants should be able to complete the exercise program without compromising their safety 
 
ExclusionCriteria 
Details  1 Severe balance impairment: Participants with a severe balance impairment
2 Recent falls: Participants who have had recent falls.
3 Participation in other exercise programs: Participants who are already enrolled in other exercise programs
4 Recent surgery or injury: Participants with recent surgery or injury
5 Cognitive impairment: Participants with cognitive impairment
6 Participant with any neurological disorders.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
berg balance scale
 
4 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Tinneti POMA scale  1st week & 4th week 
Timed-Up & Go test  1st week & 4th week 
PASE scale  1st week & 4th week 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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)   04/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  07/06/2024 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 of the study EEFECTIVENESS OF LEE SILVERMAN VOICE TREATMENT (LSVT) BIG AND STRENGTH  TRAINING ON BALANCE, PHYSICAL ACTIVITY AND RISK OF FALL IN  ELDERLY POPULATION : QUASI EXPERIMENTAL STUDY. The study is a one group experimental study with 35 sample size comprising of older adults age above 65 years with mild balance impairment . aim of the study is to assess the effectiveness of LSVT Big and strength training on balance, physical activity and risk of fall in elderly population. it is a 4 weeks of experimental study with 3 days of intervention for 1 hour consisting of 45 mins of LSVT BIG training and 15 mins of strength training. consent will be taken from the participants before the study program. LSVT BIG training consists of exercises like sustained movements  as seated floor to ceiling seated side -to- side . and directional repetitive movements as forward step sideways step backward step and lastly walking with bigger steps . all the exercises has to be done for 8-10 repetition. strength training exercises includes isometric contraction of quadriceps group of muscles and hamstring group of muscles for 10 second holds for 10 times. The screening will be done using MMSE scale for measuring level of cognition and level of balance will be measured using Berg Balance Scale. The pre intervention data will be collected using outcome measures BBS, POMA scale, TUG scale and PASE scale. Then intervention will be started and training will be given for 1 hour per session for 3 days every week for 4 weeks and home exercise program will be suggested with same exercises. After 4 weeks the post data will be taken using the same outcome measure and the data will be sent for statistical analysis to the statistician and the result will be verified. The findings of the study can help  clinicians and caregivers provide more effective and targetted intervention to improve balance, physical activity and prevent risk of falls in elderly population.The findings of this study can have significant implications for clinicians and caregivers who work with elderly populations. Here are some ways that 

 
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