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CTRI Number  CTRI/2020/06/025670 [Registered on: 06/06/2020] Trial Registered Prospectively
Last Modified On: 06/06/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Testing low-cost prosthetic (or artificial) arm developed for children 
Scientific Title of Study   3D-printed breathing-powered prosthetic arm for children 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ISRCTN15596121  ISRCTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Soikat Ghosh Moulic 
Designation  Associate Director –Technical & Quality systems (RS and PD) 
Affiliation  Mobility India 
Address  Mobility India - Rehabilitation Research & Training Centre, 1st & 1st ‘A’ Cross, J.P. Nagar, 2nd Phase, Bangalore – 560 078, Karnataka, India. mobility-india.org/

Bangalore
KARNATAKA
560 078
India 
Phone  08026494444  
Fax    
Email  soikat@mobility-india.org  
 
Details of Contact Person
Scientific Query  
Name  Mr Soikat Ghosh Moulic 
Designation  Associate Director –Technical & Quality systems (RS and PD) 
Affiliation  Mobility India 
Address  Mobility India - Rehabilitation Research & Training Centre, 1st & 1st ‘A’ Cross, J.P. Nagar, 2nd Phase, Bangalore – 560 078, Karnataka, India. mobility-india.org/

Bangalore
KARNATAKA
560 078
India 
Phone  08026494444  
Fax    
Email  soikat@mobility-india.org  
 
Details of Contact Person
Public Query  
Name  Mr Soikat Ghosh Moulic 
Designation  Associate Director –Technical & Quality systems (RS and PD) 
Affiliation  Mobility India - Rehabilitation Research & Training Centre 
Address  Mobility India - Rehabilitation Research & Training Centre, 1st & 1st ‘A’ Cross, J.P. Nagar, 2nd Phase, Bangalore – 560 078, Karnataka, India

Bangalore
KARNATAKA
560 078
India 
Phone  08026494444  
Fax    
Email  soikat@mobility-india.org  
 
Source of Monetary or Material Support  
Global Challenges Research Fund 
 
Primary Sponsor  
Name  The University of Oxford 
Address  University of Oxford University Offices Wellington Square OXFORD OX1 2JD United Kingdom 
Type of Sponsor  Research institution 
 
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 
Dr Annie Thomas  St. Johns Medical College Hospital  Department of Physiotherapy / Unit of Hope, St. John’s National Academy of Health Sciences, Sarjapur Road, Bangalore – 560034, Karnataka, India
Bangalore
KARNATAKA 		 9845656890

77anniethomas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
St John’s Medical College Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z892||Acquired absence of upper limb above wrist, (2) ICD-10 Condition: Q719||Unspecified reduction defect of upper limb,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  1. Boy or girl, aged three years to 17 years including non-wearers of a prosthetic device.

2. Individuals with a bilateral level of amputation and non-disabled children (only Stage I).

3. The participant’s parent or the legal guardian is willing and able to give permission and informed assent for his or her ward’s participation in the study.

4. Be free of neurological and musculoskeletal pathology (apart from upper limb (UL) amputation or loss for prosthesis users, and as reported by the participants or their clinician) that would impair UL motor control during goal-oriented task execution in a seated position. 
 
ExclusionCriteria 
Details  The participant may not enter the study if ANY of the following apply:

1. Generally, any medical conditions, assessed by their treating healthcare professionals, that would contraindicate the use of our prosthetic arm prototypes, such as difficulties in breathing, skin abrasions, and musculoskeletal injuries.

2. Inability to give the information required or to perform the test tasks.

3. Wounds or ulcers in the residuum.

4. Individuals with a transcarpal level of amputation (for Stage II). 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Stage I:
– Qualitative feedback provided by the study participants and their parent(s) or legal guardian via a questionnaire; Researcher-observed data

Stage II:
– Published outcome measures such as babySHAP, PUFI, and PODCI (or PedsQL) tests. 		 36 months from the date of study approval 
 
Secondary Outcome  
Outcome  TimePoints 
Stage I:
– A questionnaire-based survey by the study participants and their parent(s) or legal guardian via questionnaires (QUEST 2.0 and Nagaraja et al. 2016).


– Published outcome measures such as babySHAP and UNB tests. 		 36 months from the date of study approval 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   03/08/2020 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
Most upper limb (UL) prosthetics are generally not affordable for a vast majority of patients in low and middle-income countries. Also, the current prosthetics are often not appropriate for application in these more challenging environments. Despite significant advances in prosthetic technology, the most popular and affordable UL prosthetics for adults and children remain body-powered (BP). A BP prosthesis uses a Bowden cable (like the standard bicycle brake cables) to connect movements of the upper extremity (UE) to movements of the terminal device (hook-shaped or anthropomorphic). This technology is more than 100 years old, and it still dominates much of the market. However, the use of cables severely limits/restricts the movement possibilities of the user. An exciting prospect is the ability to provide new customised, BP prosthetics that allow the patient to position the hand anywhere in space freely. This is particularly promising for children who have a lost or missing limb, as their prosthetic operating space should not be limited as they grow and develop.
 
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