| CTRI Number |
CTRI/2017/01/007649 [Registered on: 06/01/2017] Trial Registered Prospectively |
| Last Modified On: |
03/07/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of effectiveness of JaipurBelt during manual load lifting tasks |
|
Scientific Title of Study
|
A non randomized single arm trial to evaluate effectiveness of JaipurBelt during manual load lifting tasks |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anil Kumar Jain |
| Designation |
Honorary Consultant and Head of Department Dr. P.K. Sethi Rehabilitation Centre |
| Affiliation |
Santokba Durlabhji Memorial Hospital cum Medical Research Institute |
| Address |
Dr. P.K. Sethi Rehabilitation Centre,
Santokba Durlabhji Memorial Hospital cum Medical Research Institute
Bhawani Singh Marg, Near Rambagh circle, Jaipur
Jaipur
RAJASTHAN
302015
India |
| Phone |
9829061496 |
| Fax |
|
| Email |
pksrc@sdmh.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Kumar Jain |
| Designation |
Honorary Consultant and Head of Department Dr. P.K. Sethi Rehabilitation Centre |
| Affiliation |
Santokba Durlabhji Memorial Hospital cum Medical Research Institute |
| Address |
Dr. P.K. Sethi Rehabilitation Centre,
Santokba Durlabhji Memorial Hospital cum Medical Research Institute
Bhawani Singh Marg, Near Rambagh circle, Jaipur
Jaipur
RAJASTHAN
302015
India |
| Phone |
9829061496 |
| Fax |
|
| Email |
pksrc@sdmh.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil Kumar Jain |
| Designation |
Honorary Consultant and Head of Department Dr. P.K. Sethi Rehabilitation Centre |
| Affiliation |
Santokba Durlabhji Memorial Hospital cum Medical Research Institute |
| Address |
Dr. P.K. Sethi Rehabilitation Centre,
Santokba Durlabhji Memorial Hospital cum Medical Research Institute
Bhawani Singh Marg, Near Rambagh circle, Jaipur
Jaipur
RAJASTHAN
302015
India |
| Phone |
9829061496 |
| Fax |
|
| Email |
pksrc@sdmh.in |
|
|
Source of Monetary or Material Support
|
| Newndra Innovations Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Newndra Innovations Pvt Ltd |
| Address |
1st Floor,KTR-8, Rohit Hospital Lane, Near Element Mall, DCM, Ajmer Road, Jaipur 302021, India |
| Type of Sponsor |
Other [Private Limited Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anil Kumar Jain |
Dr. P.K. Sethi Rehabilitation Centre |
Room: Main Consultation Chamber, Department: Rehabilitation and Limb Fitting Center, Santokba Durlabhji Memorial Hospital cum Medical Research Institute
Bhawani Singh Marg, Near Rambagh circle, Jaipur 302015
Jaipur
RAJASTHAN |
9829061496
pksrc@sdmh.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Santokba Durlabhji Memorial Hospital cum Medical Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal Healthy person with BMI between18 to 30, age between 18 to 70 years and height between 145 to 180 cm who frequently perform manual load lifting tasks. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
JaipurBelt(Improved Belt System for Body Support) |
Use JaipurBelt(Improved Belt System for Body Support) for 1 month, perform stoop and squat bending and load lifting of 15Kg. |
| Comparator Agent |
Without JaipurBelt(Improved Belt System for Body Support) |
Without using JaipurBelt(Improved Belt System for Body Support) perform stoop and squat bending and load lifting of 15Kg |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Male and Female subjects who frequently perform manual load lifting tasks.
Age should be between 18 years to 70 years.
Height should be between 145 cm to 180cm.
Normal Healthy Person (BMI should be between 18 to 30).
|
|
| ExclusionCriteria |
| Details |
Cases of known or suspected lower back injury.
Subjects underwent surgery or advised not to lift heavy load.
Pregnant womens.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluate the effectiveness of using the JaipurBelt during manual load lifting tasks by assessing the EMG data
Analysis of EMG data shows the effectiveness or non-effectiveness of using the JaipurBelt
|
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the ease of use, risks and adverse effect and get feedback of the device, understand the gap between device and user requirements. |
1 Year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/03/2017 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
As formal recruitment yet to start.
Publication would be planed with recruitment. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is a non randomizes, single arm, single center trail on 100 healthy subjects in India with 15 kg load lifting task in stoop and squat posture one at a time and without using the JaipurBelt and with using the JaipurBelt. The primary objective of trial is to evaluate the effectiveness of JaipurBelt during manual load lifting tasks by assessing the EMG data. The secondary objective of trails is to assess the ease of use, risks & adverse effect and get feedback of the device. Other objective is to understand the gap between device and requirements.
|