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CTRI Number  CTRI/2023/12/060781 [Registered on: 26/12/2023] Trial Registered Prospectively
Last Modified On: 23/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Return to work status in lower limb amputees in Karnataka  
Scientific Title of Study   Return to work status in lower limb amputees in Karnataka  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Allen Juda 
Designation  PG student- Masters in Occupational Therapy  
Affiliation  Manipal Academy of higher education  
Address  Department of occupational therapy Manipal college of health professions MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9677305334  
Fax    
Email  allen.mchpmpl2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr. Shovan Saha 
Designation  Associate professor 
Affiliation  Manipal Academy of higher education  
Address  Department of occupational therapy Manipal college of health professions MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9880059426  
Fax    
Email  shovan.saha@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Allen Juda 
Designation  PG student- Masters in Occupational Therapy  
Affiliation  Manipal Academy of higher education  
Address  Department of occupational therapy Manipal college of health professions MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9677305334  
Fax    
Email  allen.mchpmpl2022@learner.manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal, Karnatka 
 
Primary Sponsor  
Name  Allen Juda 
Address  Allen Juda, Occupational therapy department, Manipal college of health professions, MAHE, Manipal 
Type of Sponsor  Other [self funded ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Allen Juda  Kasturba Hospital   Allen Juda, Occupational therapy department, Kasturba Hospital
Udupi
KARNATAKA 		 9677305334

allen.mchpmpl2022@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  lower limb amputees having amputation for at least 3 months. 
 
ExclusionCriteria 
Details  Patients who have prior mental illness 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the return-to-work status on lower-limb amputees  Only once, The fist assessment , 3 months after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Exploring factors affecting return to work  6 months 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   29/12/2023 
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)
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  
Lower limb amputations comprise a considerable number, with 54.3 lakh Indians having a locomotor disability. There are roughly 0.62 amputees in India per thousand population. This translates to ten lakh individuals in the country. Most patients with lower limb amputations are young, active-earning males around 25-45 years. 
Due to lack of education, delayed access to rehabilitation and prosthetic services, mobility issues and using public transportation, negative public perceptions of disability, poor mental health, social isolation, there are restrictions on participation in the years following lower limb amputation .
The sources of emotional support are probably different from India than the Western world as the familial ties are stronger and provide close supervision and support, due to which the experiences of amputees in India might differ. 
Previous research suggests that in the western population an average of 54% return to work. They use a prosthetic device and can regain basic physical function.
In addition, people with amputation are likely to develop multiple health complications, such as obesity, cardiovascular disease, osteoarthritis, residual limb pain, and low back pain .
An amputee requires both physical and psychological adaptation and can be one of the most debilitating outcomes for patients, mainly if employed at the time of amputation. . The most frequent reasons for the long time taken to return to work were stump problems and problems in wound healing(85%), problems with the job reintegration process(46%), and mental problems (23%) 
An amputee’s return to work status has a significant economic impact on them considering it is a health problem. 

The literature review identified that lower limb amputation has an effect on their return-to-work status due to various factors; primarily pain, phantom limb sensation, level of amputation, duration after amputation. An average of 56% of amputees return-to-work. Amputees who changed their job had a high return-to-work status. Usage of rehabilitation services by amputees were low.
There are no Indian studies that find the return-to-work status in lower-limb amputees. A few studies in the western countries have reported RTW. Still, due to contextual differences, the generalization of those findings to the Indian context is limited.
Need for the study
• Most amputees are at their prime age at time of amputation. An impact on their work status will have a disturbance in the economy of the country.
• Considering the statistics of ten lakh amputees, especially in a developing country like India. There are limited findings on the return-to-work status and the factors affecting it.
• Hence, there is a need to study the return to work, and its factors on lower limb amputees.
The study will help to find the “return-to-work” status among lower-limb amputees and the various related factors which may be affecting return to work for patients with amputation in India.
 
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