| CTRI Number |
CTRI/2023/03/050274 [Registered on: 02/03/2023] Trial Registered Prospectively |
| Last Modified On: |
02/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Other (Specify) [Range of motion measuring device] |
| Study Design |
Other |
|
Public Title of Study
|
Designing and testing of objective sensor based tool to measure range of motion of body joints - An exploratory multiphasic study.
|
|
Scientific Title of Study
|
Designing and testing of innovative objective tool to measure range of motion of body joints - An exploratory multiphasic study.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chandni shukla |
| Designation |
Post graduate student |
| Affiliation |
School of physiotherapy, RK university |
| Address |
School of physiotherapy, RK University, Kasturbadham, Rajkot- Bhavnagar highway, Rajkot - 360020, Gujarat, India.
Rajkot
GUJARAT
3600200
India |
| Phone |
7069881297 |
| Fax |
|
| Email |
cshukla870@rku.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mansi shah |
| Designation |
Assistant Professor, SPT, RK University |
| Affiliation |
School of Physiotherapy, RK university |
| Address |
School of Physiotherapy, RK University, Kasturbadham, Rajkot- Bhavnagar highway, Rajkot - 360020, Gujarat, India
Rajkot
GUJARAT
360020
India |
| Phone |
9409053462 |
| Fax |
|
| Email |
mansi.shah@rku.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
chandni shukla |
| Designation |
Post graduate student |
| Affiliation |
School of Physiotherapy, RK university |
| Address |
School of Physiotherapy, RK University, Kasturbadham, Rajkot- Bhavnagar highway, Rajkot - 360020, Gujarat, India
Rajkot
GUJARAT
360020
India |
| Phone |
7069881297 |
| Fax |
|
| Email |
cshukla870@rku.ac.in |
|
|
Source of Monetary or Material Support
|
| School of Physiotherapy, RK University |
|
|
Primary Sponsor
|
| Name |
Chandni Shukla |
| Address |
School of Physiotherapy, RK University, Kasturbadham, Rajkot- Bhavnagar highway, Rajkot - 360020, Gujarat, India. |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| School of physiotherapy RK university |
School of physiotherapy, RK University, Kasturbadham, Rajkot- Bhavnagar highway, Rajkot - 3600200, Gujrat, India. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Chandni shukla |
Research Department , School of Physiotherapy , RK univdersity |
School of physiotherapy, RK University, Kasturbadham, Rajkot- Bhavnagar highway, Rajkot - 3600200, Gujrat, India.
Rajkot
GUJARAT |
07069881297
cshukla870@rku.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee, School of Physiotherapy, RK University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy human volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
innovative objective sensor based tool |
It measure the range of motion of body joints on the spot |
| Comparator Agent |
Goniometer |
it measures the range of motion of body joints. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Gender male and female both
All age included
|
|
| ExclusionCriteria |
| Details |
Non consent subject
Psychiatric illness or non cooperative patients
Painfull symptoms at particular joints.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Range of motion |
1st day |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="370"
Sample Size from India="370"
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)
|
10/03/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
TITLE : DESIGNING AND TESTING OF INNOVATIVE OBJECTIVE TOOL TO MEASURE RANGE OF MOTION OF BODY JOINTS- AN EXPLORATORY MULTIPHASIC STUDY†INVESTIGATOR : CHANDNI SHUKLA , DR. MAITREY PANDYA, MPT NEUROMUSCULAR SCIENCE, ASSISTANT PROFESSOR, SPT, RK UNIVERSITY BACKGROUND: Mesurement of range of motion is an important part of clinical assesment. So accurate measurment of range of motion is very essential for assesment and rehablitation part. In this study designing and testing the innovative sensor based digial device to measure all range of motion pf body joints and give the reading on display.
|