Robotic hand-assisted Transcranial Magnetic Stimulation therapy for rehabilitation from brain damage caused by stroke
| ISRCTN | ISRCTN95291802 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95291802 |
| Secondary identifying numbers | YSS/2015/000697 |
- Submission date
- 19/10/2020
- Registration date
- 23/10/2020
- Last edited
- 17/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
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
Contact information
Scientific
Indian Institute of Technology Delhi
Hauz Khas
Delhi
110016
India
 ORCID ID |
0000-0001-6477-2462 |
|---|---|
| Phone | +91 112659 6230 |
| amehndiratta@cbme.iitd.ac.in |
Study information
| Study design | Interventional single-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| 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 |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/01/2015 |
| Completion date | 31/03/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 43 |
| Key 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) |
| Key exclusion criteria | 1. Contra-indications to TMS 2. Progressive neurological or cognitive disorders impinging with assessment scales |
| Date of first enrolment | 01/10/2015 |
| Date of final enrolment | 15/02/2020 |
Locations
Countries of recruitment
- India
Study participating centres
New Delhi
110029
India
New Delhi
110016
India
Sponsor information
Government
Department of Science and Technology
5 & 5A, Lower Ground Floor
Vasant Square Mall
Sector-B, Pocket-5
Vasant Kunj
New Delhi
110070
India
| Phone | +91 1140000358 |
|---|---|
| response@serb.gov.in | |
| Website | http://www.serb.gov.in/home.php |
"ROR" |
https://ror.org/03ffdsr55 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- विज्ञान और इंजीनियरिंग अनुसंधान बोर्ड, SERB
- Location
- India
Results and Publications
| Intention to publish date | 01/10/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 23/09/2019 | 19/10/2020 | Yes | No |
| Other publications | 25/05/2023 | 17/11/2023 | Yes | No | |
| Results article | 06/05/2021 | 17/11/2023 | Yes | No | |
| Results article | 25/07/2022 | 17/11/2023 | Yes | No |
Editorial Notes
17/11/2023: Publication references added.
22/10/2020: Trial’s existence confirmed by All India Institute of Medical Sciences.
