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
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)