| CTRI Number |
CTRI/2018/05/013876 [Registered on: 14/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
05/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Physiotherapy (Not Including YOGA)
Other (Specify) [Rehabilitation] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Brain controlled robot for hand rehabilitation |
|
Scientific Title of Study
|
Experimental Evaluation of a Brain-Computer Interface Operated Hand Exoskeleton for Movement Restoration in Paralysis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashish Dutta |
| Designation |
Professor |
| Affiliation |
Indian Institute of Technology, Kanpur |
| Address |
NL 312, Mechanical Engineering Department, IIT Kanpur, Kanpur 208016, UP, India
Kanpur 208016
Kanpur Nagar
UTTAR PRADESH
208016
India |
| Phone |
9621488633 |
| Fax |
|
| Email |
adutta@iitk.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Dutta |
| Designation |
Professor |
| Affiliation |
Indian Institute of Technology Kanpur |
| Address |
NL 312, Mechanical Engineering Department, IIT Kanpur, Kanpur 208016, UP, India
Kanpur 208016
Kanpur Nagar
UTTAR PRADESH
208016
India |
| Phone |
9621488633 |
| Fax |
|
| Email |
adutta@iitk.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish Dutta |
| Designation |
Professor |
| Affiliation |
Indian Institute of Technology Kanpur |
| Address |
NL 312, Mechanical Engineering Department, IIT Kanpur, Kanpur 208016, UP, India
Kanpur 208016
Kanpur Nagar
UTTAR PRADESH
208016
India |
| Phone |
9621488633 |
| Fax |
|
| Email |
adutta@iitk.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Science and Technology(DST) and UKIERI |
|
|
Primary Sponsor
|
| Name |
DST |
| Address |
Technology Bhavan, New Mehrauli Road, New Delhi, Delhi 110 016 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| UKIERI |
17 Kasturba Gandhi Marg, New Delhi 110001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashish Dutta |
Regency Hospital |
A 2, Sarvodaya Nagar, Kanpur
Kanpur Nagar
UTTAR PRADESH |
9621488633
adutta@iitk.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Hemiplegia due to stroke, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BCI based Hand Exoskeleton |
The hand exoskeleton feedback was provided to the patients with anthropomorphic visual feedback in terms of a stop motion video of a hand extension action, which were contingent to the on going brain activity of the patients measured by a EEG signal acquisition device and novel signal processing algorithm. Participants undergone 2-3 therapy sessions per week for up to 6 weeks. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
24.00 Year(s) |
| Age To |
62.00 Year(s) |
| Gender |
Both |
| Details |
1. Stroke patients suffering from hand plegia.
2. Time since stroke greater than or equal to 6 months.
|
|
| ExclusionCriteria |
| Details |
1.Cognitively impaired.
2.Having a history of epilepsy.
3.Medically unstable.
4. High muscle spasticity in hand.
5. High tremor in hand. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The hand functional recovery was measured using standard outcome measurement techniques such as grip strength(GS) using a dynamometer and action research arm test (ARAT) on the scale of 0 to 57. The performance of the brain activity was measured in terms of BCI classification accuracy and the event-related synchronization and de-synchronization in the brainwave.
|
The time points of outcome measurement were at every alternate session for GS and ARAT and for brain-activity it was at each session. It is to be noted that 2-3 sessions were done per week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcomes were the measurement of mood, fatigue and motivation of the participants on visual-analogue-scale (VAS) between 0 to 10. |
Time points were after every session. |
|
|
Target Sample Size
|
Total Sample Size="4"
Sample Size from India="4"
Final Enrollment numbers achieved (Total)= "4"
Final Enrollment numbers achieved (India)="4" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2016 |
| Date of Study Completion (India) |
31/10/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
1. A. Chowdhury et al., "Online Covariate Shift Detection based Adaptive Brain-Computer Interface to Trigger Hand Exoskeleton Feedback for Neuro-Rehabilitation," IEEE Cognitive and Developmental Systems, 2017. DOI: 10.1109/TCDS.2017.2787040
2. A. Chowdhury et al., "EEG-EMG Based Hybrid Brain Computer Interface for Triggering Hand Exoskeleton for Neuro-Rehabilitation," in Proceedings of the International Conference on Advances in Robotics, New Delhi, 2017, pp. 45:1-45:6, DOI: 10.1145/3132446.3134909.
3. G. Prasad et al., "Combining mental and physical practice using brain computer interface driven hand exoskeleton for personalized post-stroke neuro-rehabilitation," in Proceedings of the 8th Annual Translational Medicine (TMED8) Conference, Londonderry, 2017.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The primary purpose of the study is to find out the impact of BCI operated hand exoskeleton based combined mental and physical practice on hemiplegic stroke patients for hand functional recovery. The study protocol involves the recruitment of hemiplegic stroke patients suffering from hand disability for at least 6 months and conducting a hand therapy for 12-16 sessions spanning over 3 months. The intervention was to trigger the hand-exoskeleton using the patient’s brain wave followed by an assist-as-needed physical practice using the hand-exoskeleton only. The hypothesis was that the proposed intervention would lead to the motor functional recovery of the disabled hand. |