| 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
|
|
|
Primary Sponsor
|
| Name |
SMRITY RAI |
| Address |
Devarakaggalahalli Harohalli Kanakapura Road Dt Ramanagara Karnataka 562112 |
| Type of Sponsor |
Other [other (self)] |
|
|
Details of Secondary Sponsor
|
|
|
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
|
|
|
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 |