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CTRI Number  CTRI/2019/05/019054 [Registered on: 10/05/2019] Trial Registered Prospectively
Last Modified On: 08/05/2019
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Development of artificial hand for paralyzed patients 
Scientific Title of Study   Development of wearable artificial muscle for a Tetraplegic Hand 
Trial Acronym   
Secondary IDs if Any    
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr H S Chhabra 
Designation  Medical Director and Chief of Spine Services 
Affiliation  Indian Spinal Injuries Centre 
Address  Indian Spinal Injuries Centre, Vasant Kunj New Delhi 110070

South West
DELHI
110070
India 
Phone    
Fax    
Email  drhschhabra@isiconline.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr H S Chhabra 
Designation  Medical Director and Chief of Spine Services 
Affiliation  Indian Spinal Injuries Centre 
Address  Indian SPinal Injuries Centre, Vasant Kunj New Delhi 110070

South West
DELHI
110070
India 
Phone    
Fax    
Email  drhschhabra@isiconline.org  
 
Details of Contact Person
Public Query
 
Name  Dr H S Chhabra 
Designation  Medical Director and Chief of Spine Services 
Affiliation  Indian Spinal Injuries Centre 
Address  Indian Spinal Injuries Centre, Vasant Kunj New Delhi 110070

South West
DELHI
110070
India 
Phone    
Fax    
Email  drhschhabra@isiconline.org  
 
Source of Monetary or Material Support  
Canada India SCI Innovation Award 2018, Unit 305, 6190 Agronomy Rd University of British Columbia Vancouver, British Columbia V6T 1Z3 
 
Primary Sponsor  
Name  Canad India SCI Innovation award  
Address  Canad India SCI innovation Award 2018, Unit 305, 6190 Agronomy Rd University of British Columbia Vancouver, British Columbia V6T 1Z3 
Type of Sponsor  Other [Rick Hansen Institute IC IMPACTS and ISIC] 
 
Details of Secondary Sponsor  
Name  Address 
IC IMPACTs RHI ISIC  Canada India SCI Innovation Award 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr H S Chhabra  Indian Spinal Injuries Centre  Deaprtment of rehabilitation and institute of rehabilitation, Vasant Kunj New Delhi
South
DELHI 
911142255243

drhschhabra@isiconline.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ISIC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G952||Other and unspecified cord compression,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Chronic cervical spinal cord injured patients with upper limb paralysis  The patients will be given routine physiotherapy along with the artificial hand being developed. The scores will be measured using SHAP score. The therapy will be given for 30 minutes in each session. The session will be given on daily basis ( supervised or by care givers). the assessment will be done on 0 3 and 6 months. 
Comparator Agent  Chronic Cervical Spinal COrd Injured Patients with Upper Limb Paralysis  The patients will be given routine physiotherapy. The scores will be measured using SHAP score. The therapy will be given for 30 minutes in each session. The session will be given on daily basis ( supervised or by care givers). the assessment will be done on 0 3 and 6 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Cervical spinal cord injured individuals, 18 years of age or older , ASIA A, B, C
Have sustained a SCI for the preceding 6 months,
Ability to hold a 2.54-cm block of Box and Block apparatus with the thumb 
 
ExclusionCriteria 
Details  Any co-morbidities with SCI such as head injury or any other injury affecting the the target hand (e.g. brachial plexus or peripheral nerve injuries)
have had trauma or surgery to the target hand or upper limb within the last 12 months
amputation of any digits on the target hand
not able to sit out of bed for at least two hours per day over three consecutive days
Any psychiatric illness diagnosed
Unstable patients
Contractures in targeted hand, spasticity more than grade 1 on modified ashworth scale

 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
A soft robotic glove for hand functionality augmentation for tetraplegic patient.

Initial functionality, based on what the control system would be developed is a grasping movement.

In short, a wearable gloves, which will act as an external muscle, and help the patient fold his hand to grasp.  
o, 3 and 6 months assessment will be done using neurlogical scales. 
 
Secondary Outcome  
Outcome  TimePoints 
A soft robotic glove for hand functionality augmentation for tetraplegic patient.

Initial functionality, based on what the control system would be developed is a grasping movement.

In short, a wearable gloves, which will act as an external muscle, and help the patient fold his hand to grasp.  
The assessment will be done at 0,3 and 6 months period after the gloves are made. THe neurology and outcome measures will be compared. 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 1 
Date of First Enrollment (India)   01/01/2020 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

PART B

MAIN APPLICANT

PROJECT TITLE (maximum 12 words) 

 

Development of wearable artificial muscle for a tetraplegic hand

 

 

 

 

First name:

Harvinder

Last name:

Chhabra

Qualifications:

MBBS, MS, PGDHHM

University/Institution:

Indian Spinal Injuries Centre

Department:

Spine

Email:

drhschhabra@isiconline.org

Telephone:

+91-11-42255243

Fax:

 

 

 

 

Co-Applicant (optional)

First name:

Sitikantha

Last name:

Roy

Qualifications:

PhD

University/Institution:

Indian Institute of Technology, Delhi

Department:

Applied Mechanics

Email:

sroy@am.iitd.ac.in

Telephone:

01126591220

Fax:

 

 

Canadian Co-Principal Investigator (optional)

First name:

 

Last name:

 

Qualifications:

 

University/Institution:

 

Department:

 

 

 

 

 

Email:

 

Telephone:

 

Fax:

 

 

Indian Co-Principal Investigator  (optional)

First name:

Shakti

Last name:

Goel

Qualifications:

MBBS, MS

University/Institution:

Indian Spinal Injuries Centre, New Delhi

Department:

Spine

Email:

shaktiagoel@gmail.com

Telephone:

+918980013541

Fax:

 

 

 

First name:

Nishu Tyagi

Qualifications:

BOT, MOT

University/Institution:

Indian Spinal Injuries Centre, New Delhi

Department:

Rehabilitation

Email:

nishutyagi08@gmail.com

Telephone:

+918826004954

Fax:

 

 

PART C

1. PROJECT SUMMARY

2. Project title:

 Development of wearable artificial muscle for a tetraplegic hand

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Keywords:

 

 Tetraplegic Hand, Soft robotics, Innovations in functional improvement,measurable social impact ,  increased mobility of SCI patients, foster Canada-India research and trade , demonstrate effectiveness of technologies in market

 

 

 

 

 

3. Project time and cost

Proposed project duration (18 to 24 months):

24months

Total budget for the project:

CAD $ 50000

Total requested budget from the Grant:

CAD $ 50000

 

4. Project abstract. Maximum 400 words. Outline the objectives, the current status of technology, the relevance to Canada-India relations and SCI/secondary complications, and expected impact of people living with SCI and secondary complications.

Cervical spinal cord injury (SCI) is a catastrophic condition requiring chronic care. Majority of the patients with SCI are young, and the economic and societal impact is enormous, both to the immediate family and the society at large. A number of rehabilitative procedures have been described for cervical spinal cord injury patients with little benefits. Though a majority of rehabilitation method aims at preventing contractures in paralyzed muscles, literature studies have shown little significant improvement in the neurology of cervical spinal cord injury patients after only rehabilitation methods. A radiologically successful surgery doesn’t guarantee full recovery of power or employability to a patient. Hence there is a need to develop a modality which shall act as an aid that shall mimic the muscle activity of the hand and help the paralyzed patient in performing motor functions.

We at IIT have developed pneumatic artificial muscles in the form of gloves which works as an external skeleton. These gloves work based on the principles of soft robotics which have major advantage over the hard robotics, in terms of wearability and tissue-like stiffness. A motor based cable push-pull drive is going to be augmented with the soft pneumatic actuation to increase the actuating stroke. Hand movement, like grasping is achieved by breaking it down into some simple synchronous muscle extension and contraction activities performed by mechanical tendon and soft actuator. Initial focus is going to be on grasping, later other hand motions like pinching, hooking etc can be augmented.

The ability of the artificial muscle to provide supplemental power for various activity will be evaluated using EMG signals. These signals will be extracted from the forearm muscles of normal individuals and the artificial muscles will be required to simulate the same. This will be achieved by synchronous activity of pneumatic systems, pulley systems. The tendon sheath will be a microfiber which will be controlled with stepper motor driven pulley systems and connected at the finger joints of gloves to mimic the biomechanical activity.

 

Once the gloves are ready they will be tried at the rehabilitation centre of ISIC under the supervision of a surgeon and rehabilitation professional after necessary ethical clearance and informed consent. The gloves will be evaluated based on SHAP (Southampton Hand Assessment Procedure). The SHAP is comprised of tasks which require the manipulation of 12 abstract objects and the performance of 14 activities of daily living (ADLS), all of which require use of the spherical, tripod, power, lateral, tip and extension grasps. The ADLS utilized in the SHAP consist of: picking up coins, undoing buttons, cutting food, turning pages, removing a jar lid, pouring from a glass measuring cup, pouring from a carton, lifting a heavy jar, lifting a light can, lifting a tray, rotating a key, opening/closing a zipper, rotating a screw, and using a door handle.

 

 

5. Describe at a high level your action plan to achieve the goals and milestones of your project with the funds awarded. Maximum 300 words.

The soft robotic hand exoskeleton technology will be developed in the Department of Applied Mechanics, IIT Delhi. The actuator development, characterization and block force optimization, material characterization, control board development, algorithm development, form factor printing and assembly will be done in IIT Delhi campus, with constant feedback from the ISIC surgeons and faculties.

Once the gloves are ready they will be tested at the rehabilitation centre of ISIC under the supervision of a surgeon and rehabilitation professional after necessary ethical clearance and informed consent. The gloves will be evaluated based on SHAP (Southampton Hand Assessment Procedure). The SHAP is comprised of tasks which require the manipulation of 12 abstract objects and the performance of 14 activities of daily living (ADLS), all of which require use of the spherical, tripod, power, lateral, tip and extension grasps. The ADLS utilized in the SHAP consist of: picking up coins, undoing buttons, cutting food, turning pages, removing a jar lid, pouring from a glass measuring cup, pouring from a carton, lifting a heavy jar, lifting a light can, lifting a tray, rotating a key, opening/closing a zipper, rotating a screw, and using a door handle.

We also plan to develop a hand rehabilitation metric based on the feedback received from the quantitative measurement of actuation force during different stages of rehabilitation process.  

The work can be divided into following stages

1. Development of artificial muscle actuator

l Pneumatic Actuation

l Fiber Reinforced Actuators

l Pneumatic Artificial Muscle

l Pneunets Actuators

l Mechanical Tendon routing, combining metal wire with artificial muscle

 

2. Design, optimization and Morphological Simulation

 

3. Control of device

4. Assessment of artificial muscles on patients using SHAP

 

 

 

 

 

 

6. Describe how your project will benefit people living SCI or secondary complications. Maximum 300 words. Describe the commercial or practical use of the end result of your project. Specify the value proposal of your project. For instance: the outcome of my project will lower the cost of diagnostics by 25% or will reduce surgery time by 20%.

Currently there are few devices to cater to the basic needs such as holding glass, brushing teeth etc for SCI patients with upper limb paralysis. The low cost splints which are currently available can cater to a specific need of the patient and require assistance from the caregiver. A device like the present one, after being worn, will be able to perform multiple functions depending on the need and requirement of the patient.  Furthermore, this will also help in reducing the complications like contractures, deformities, stiffness etc by passive functional mobilization of hand.

If this project is successful, at the next stage a Brain Computer Interface can be added for the soft robotic hand control using brain signal.  

A wearable hand robot that restores basic hand and finger function would greatly improve quality of life for people with hand mobility problems. Such a hand robot should be natural looking and simple to implement so that people feel psychologically comfortable wearing it.

 

 

7. Do you have existing bilateral partners? If not, describe the profile of a potential partner who may help us identify bilateral partner (e.g., SCI specialist, electrical engineer).

Yes, Indian Spinal Injuries Centre is working in collaboration with Indian Institute of Technology, Delhi. Dr Sitikantha Roy is an Associate Professor there in the department of Applied Mechanics and has been working closely in this field.

Indian Spinal Injuries Centre is also working in close association with Stanford University. Dr Shakti Srivastava is a surgeon there who is working with ISIC in developing a tetraplegic hand unit.

 

8. Describe the series of steps needed for you to achieve your project goals. Please sketch out or create a diagram or flowchart to help describe the process.

0-0.5 year: lectures and conferences to be organized at IIT and ISIC to sensitize the problem statement in SCI patients and the state of art in soft robotics. Engineers will be sensitized about the anatomy of hand and how the muscles synchronize together to perform the grasping/ gripping activity. Clinicians will be made aware about the soft robotics and its ability to mimic the functions of the muscles. Ethical clearance for the study from the institutional review board will be taken. The patients’ information sheet and the informed consent form will be designed in the manner as enclosed as additional attachment.

0.5-1 years: product development and prototyping

1-2 years: Optimizing the design and patient trials. The gloves will be evaluated based on SHAP (Southampton Hand Assessment Procedure). The SHAP is comprised of tasks which require the manipulation of 12 abstract objects and the performance of 14 activities of daily living (ADLS), all of which require use of the spherical, tripod, power, lateral, tip and extension grasps. The ADLS utilized in the SHAP consist of: picking up coins, undoing buttons, cutting food, turning pages, removing a jar lid, pouring from a glass measuring cup, pouring from a carton, lifting a heavy jar, lifting a light can, lifting a tray, rotating a key, opening/closing a zipper, rotating a screw, and using a door handle.

 

 

 
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