Condition category
Nervous System Diseases
Date applied
19/10/2020
Date assigned
23/10/2020
Last edited
22/10/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Background and study aims:
Stroke is a disturbance in local blood supply in the brain resulting in the improper functioning of the body part. There are different approaches to treatment in chronic stroke, such as physiotherapy, brain stimulation, medicines, and robotic devices. The use of two rehabilitation strategies at the same time can facilitate a faster recovery process.
Transcranial magnetic stimulation (TMS) is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain.
Our aim is to combine brain stimulation (TMS) and robotic-assisted physiotherapy that might serve as a relatively more effective treatment plan for rehabilitation of wrist joint and fingers joint of post-stroke patients.

Who can participate?
Patients aged 18 - 70 years, with stroke or paralysis.

What does the study involve?
The study involves giving therapy sessions/interventions (details given in the intervention section) to patients with stroke. Clinical evaluation is done before and after completion of therapy sessions. Clinical data acquisition includes functional MRI, clinical scales, cortical excitability measures, and subjective feedback.

What are the possible benefits and risks of participating?
The information we get from the study will help to improve the functioning of hand with stroke and to increase the understanding of the treatment of stroke. Improvements are expected in upper limb movement and function depending upon the size and location of stroke but might not be directly beneficial to the patients enrolled. No direct risk to patients is involved.

Where is the study run from?
1. All India Institute of Technology, New Delhi
2. Indian Institute of Technology, Delhi

When is the study starting and how long is it expected to run for?
January 2015 to March 2020

Who is funding the study?
Science and Engineering Research Board, Department of Science and Technology, India

Who is the main contact?
Dr. Amit Mehndiratta, amitvmehndiratta@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Amit Mehndiratta

ORCID ID

http://orcid.org/0000-0001-6477-2462

Contact details

Indian Institute of Technology Delhi
Hauz Khas
Delhi
110016
India
+91 112659 6230
amehndiratta@cbme.iitd.ac.in

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

YSS/2015/000697

Study information

Scientific title

Comparison of clinical outcomes of robotic hand exoskeleton assisted Transcranial Magnetic Stimulation therapy with dose-matched conventional upper limb rehabilitation: A Randomized Clinical Trial on patients with stroke

Acronym

Study hypothesis

Robotic hand exoskeleton assisted Transcranial Magnetic Stimulation therapy will show higher improvement of distal-function and cortical-excitability in patients with stroke as compared to conventional-rehabilitation.

Ethics approval

Approved 17/07/2015, Institute Ethics Committee, All India Institute of Medical Sciences (Room no. 2, First floor, Old OT Block, Ansari Nagar, New Delhi, 110029, India; +91 11 26594579; email:ethicscommitteeaiims@gmail.com), ref: IEC/NP-99/13.03.2015, RP-02/2015

Study design

Interventional single-blinded randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a participant information sheet

Condition

Evaluation of clinical outcomes in response to the robotic hand-assisted Transcranial Magnetic Stimulation (TMS) therapy in patients with stroke

Intervention

Patients with stroke are randomly divided into 4 groups:
1. Comparator Agent: Physiotherapy - Patient will be asked to do clinical physiotherapy as prescribed by the therapist
2. Intervention: Robotic exoskeleton Assisted Therapy - Patient will be asked to do robotic-assisted rehabilitation therapy
3. Intervention: TMS integrated with robotic exoskeleton device - Patient will be asked to undergo TMS and robotic-assisted therapy, TMS will be given at 0.1 Hz frequency at 100% Resting Motor Threshold
4. Intervention: TMS therapy - patient will be asked to undergo TMS therapy, TMS will be given at 0.1 Hz frequency at 100% Resting Motor Threshold

The interventions take place 5 days a week for 4 weeks (total 20 sessions)

Assessments will be made before and after 20 therapy sessions.

Randomization:
The clinical trial followed a manual simple randomization method. The clinical recruitment of all patients is done in a group of four patients. Once four patients are recruited, they are allocated a pre-defined sequence. Four patients are then instructed to choose one out of 4 colour cards in that specific sequence. The cards they choose signify the groups they are enrolled in for the study.

Intervention type

Device

Phase

Phase I

Drug names

Robotic Hand exoskeleton Device

Primary outcome measure

At baseline and 4 weeks:
1. Spasticity of wrist joint measured using the Modified Ashworth Scale (MAS)
2. Sequence of stages of recovery post-stroke measured using the Brunnstrom stage (BS)
3. Functional independence of patient in Activity of Daily Living (ADL) measured using the Barthel Index
4. Performance-based sensorimotor function index of whole arm measured using Fugl-Meyer Assessment (FMA)
5. Wrist-joint movement without assistance measured through Active Range of Motion on scale: 0 to 70 degrees
6. Disability measurement using the Modified Rankin Scale
7. Patient experience with the therapy sessions using self-designed subjective questionnaire feedback in terms of use, functionality, ease of use, potential of home-based use, user-friendly etc.
8. User-feedback on the usability, complexity and ease of use measured using an industry based System Usability Scale

Secondary outcome measures

At baseline and 4 weeks:
1. Cortical Excitability measurements:
1.1. Peak to peak amplitude (in microvolts) of Motor Evoked Potential (MEP) response of cortex measured using Transcranial Magnetic Stimulation
1.2. Resting Motor Threshold Intensity (in %) to generate the MEP measured using Transcranial Magnetic Stimulation
1.3. Latency period of MEP (in milliseconds), measured using Transcranial Magnetic Stimulation
2. Functional Magnetic Resonance Imaging measures:
2.1. Number of active voxels in different regions of brain while performing the wrist extension task, measuring neuronal activity
2.2. Volume of activation of brain while performing the wrist extension task, measuring neuronal activity
2.3. Structural MRI, measuring any structural changes in brain

Overall trial start date

01/01/2015

Overall trial end date

31/03/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1.18 - 70 years of age
2. Single lesioned, Chronic (3 months - 24 months) stroke
3. Cortical/sub-cortical, Ischemic/Hemorrhagic stroke,
4. Modified Ashworth Scale (1,1+, 2), Brunnstrom stage (3-5), Medical Research Council Scale (2-4),
5. Should have motor cortex MEP >= 10uv in lesion hemisphere,
6. Should have wrist extension EMG activity,
7. Is able to give informed consent
8. Can follow the instruction to execute training task with Mini-Mental Scale (MMS 24 - 30)

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

40

Total final enrolment

43

Participant exclusion criteria

1. Contra-indications to TMS
2. Progressive neurological or cognitive disorders impinging with assessment scales

Recruitment start date

01/10/2015

Recruitment end date

15/02/2020

Locations

Countries of recruitment

India

Trial participating centre

All India Institute of Medical Sciences
Ansari Nagar
New Delhi
110029
India

Trial participating centre

Indian Institute of Technology
Hauz Khas
New Delhi
110016
India

Sponsor information

Organisation

Science and Engineering Research Board

Sponsor details

Department of Science and Technology
5 & 5A
Lower Ground Floor
Vasant Square Mall
Sector-B
Pocket-5
Vasant Kunj
New Delhi
110070
India
+91 1140000358
response@serb.gov.in

Sponsor type

Government

Website

http://www.serb.gov.in/home.php

Funders

Funder type

Government

Funder name

Science and Engineering Research Board

Alternative name(s)

विज्ञान और इंजीनियरिंग अनुसंधान बोर्ड, SERB

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

India

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact journal.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

01/10/2021

Participant level data

Other

Basic results (scientific)

Publication list

2019 results in https://doi.org/10.1109/TNSRE.2019.2943005 (added 19/10/2020)

Publication citations

Additional files

Editorial Notes

22/10/2020: Trial’s existence confirmed by All India Institute of Medical Sciences.