| CTRI Number |
CTRI/2024/04/065370 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
08/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Other (Specify) [A mixed method study] |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of ergonomic risk factors and Impact of physiotherapy intervention on pinch strength and hand performance in goldsmith workers |
|
Scientific Title of Study
|
EVALUATION OF ERGONOMIC RISK FACTORS AND IMPACT OF PHYSIOTHERAPY INTERVENTION ON PINCH STRENGTH AND HAND PERFORMANCE IN GOLDSMITH WORKERS - A MIXED METHOD STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BHAVSAR MINALBEN NARENDRABHAI |
| Designation |
LECTURER IN PHYSIOTHERAPY |
| Affiliation |
Government physiotherapy college, Ahmedabad |
| Address |
Government physiotherapy college and government spine institute, Room no. 205 second floor
opposite cancer hospital, civil hospital, asarwa Ahmedabad- 380016
Ahmadabad
GUJARAT
380016
India |
| Phone |
9723344529 |
| Fax |
|
| Email |
minal.vsn1982@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavana Rajeshkumar Gadhavi |
| Designation |
Dean and Principal at Parul University |
| Affiliation |
Parul Institute of Physiotherapy, Vadodara |
| Address |
Parul Institute of Physiotherapy, Parul University, P.O Limda., TA- Vaghodiya, Dist.- VAdodara
Vadodara
GUJARAT
391760
India |
| Phone |
9727729787 |
| Fax |
|
| Email |
Bhavana.gadhavi28222@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
BHAVSAR MINALBEN NARENDRABHAI |
| Designation |
LECTURER IN PHYSIOTHERAPY |
| Affiliation |
Government physiotherapy college, Ahmedabad |
| Address |
Government physiotherapy college and government spine institute, Room no.205 second floor
opposite cancer hospital, civil hospital, asarwa Ahmedabad- 380016
Ahmadabad
GUJARAT
380016
India |
| Phone |
9723344529 |
| Fax |
|
| Email |
minal.vsn1982@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government physiotherapy college and government spine institute,
opposite cancer hospital, civil hospital, asarwa Ahmedabad- 380016
India |
|
|
Primary Sponsor
|
| Name |
Bhavsar Minalben Narendrabhai |
| Address |
Government spine institute and physiotherapy college, civil hospital, Ahmedabad
Government Spine Institute and physiotherapy college, civil hospital Ahmedabad
|
| Type of Sponsor |
Other [self] |
|
|
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 |
| Bhavsar Minalben Narendrabhai |
In community Different cities of Gujarat |
Government physiotherapy OPD department, civil hospital, Ahmedabad, different areas of Gujarat
Ahmadabad
GUJARAT |
9723344529
minal.vsn1982@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Shree Swaminarayan Physiotherapy College- Ranip |
Approved |
| PHDNOC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal Young Adult population
and Goldsmith Workers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ergonomic intervention and grip strengthening exercise |
Intervention given in phase 3
Group1- Ergonomic intervention plus instrument assisted grip strengthening exercise
Group 2- Ergonomic intervention in form of Modification and rest plus exercise will be given for 4 weeks and 5 days a week |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
study is divided in to 3 phases.
phase 1-Healthy adult population
Willingness to Participate
phase 2- goldsmith Workers who have been making ornaments for at least last 1 year
Workers who are working minimum for more than 5 hours/day for 6 days/week or 30 hrs. a week
phase 3-Reduction in pinch strength and hand performance
|
|
| ExclusionCriteria |
| Details |
Musculoskeletal pain in upper limb and hand
Neurological disorder that affects upper limb and hand
R.O.M deficit in elbow and hand
Any radiating/referred pain in Upper limb
h/o any upper limb injury less than 1 year
Any systemic infection having pain and inflammation in wrist and hand, Any congenital or acquired deformity for the hand
Cardiac, pulmonary and metabolic disorders affecting muscular strength
Subjects with dysfunction of Neck, shoulder or elbow joint
Subjects who does not understand the command
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pinch strength
Rapid Upper limb assessment,
Work productivity and activity impairment questionnaire |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Michigan Hand Outcome questionnaire
Disability of Arm, shoulder and hand |
2 years |
|
|
Target Sample Size
|
Total Sample Size="2000"
Sample Size from India="2000"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/04/2024 |
| 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="2"
Months="0"
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
|
There is a need to raise awareness on occupational health and safety issues among goldsmith workers across the country and suggest safety methods to protect them. The aim of the study is to assess the current working condition and to suggest the low-cost ergonomic means to improve occupational health and work performance through work tool development possibilities. The hand strength may vary significantly according to occupation so the purpose of this study is to understand the demand level of hand use for the benefit of hand rehabilitation. The objective of this study is to identify and prevent or reduce the occurrence of work-related musculoskeletal problem in goldsmith workers by providing early ergonomic intervention by assessing the pinch strength and to rule out the improvement of pinch strength and hand performance after the exercise program. |