| 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 |
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Type of Study
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| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
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Development of artificial hand for paralyzed patients |
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Scientific Title of Study
|
Development of wearable artificial muscle for a Tetraplegic Hand |
| Trial Acronym |
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Secondary IDs if Any
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| 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 |
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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 |
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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 |
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Source of Monetary or Material Support
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| Canada India SCI Innovation Award 2018, Unit 305, 6190 Agronomy Rd
University of British Columbia
Vancouver, British Columbia
V6T 1Z3 |
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Primary Sponsor
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| 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] |
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Details of Secondary Sponsor
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| Name |
Address |
| IC IMPACTs RHI ISIC |
Canada India SCI Innovation Award |
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Countries of Recruitment
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India |
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Sites of Study
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| 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 |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ISIC |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G952||Other and unspecified cord compression, |
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Intervention / Comparator Agent
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| 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. |
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Inclusion Criteria
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| 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
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Method of Generating Random Sequence
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Other |
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Method of Concealment
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Alternation |
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Blinding/Masking
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Double Blind Double Dummy |
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Primary Outcome
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| 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. |
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Secondary Outcome
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| 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. |
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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" |
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Phase of Trial
|
Phase 1 |
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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 |
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Estimated Duration of Trial
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Years="2" Months="0" Days="0" |
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Recruitment Status of Trial (Global)
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Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
nil yet |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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| | | Development of wearable artificial muscle for a tetraplegic hand | | | | | | | | | | | | | | | | | | | | |
| | 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 | | Proposed project duration (18 to 24 months): | 24months | | | | |
| 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. |
| 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 |
| 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. |
| 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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