Robotic hand therapy for rehabilitation after brain damage caused by stroke
| ISRCTN | ISRCTN28431480 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28431480 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 55/4/1/CARE-Disability & AT/2020/NCD-II |
| Sponsor | Indian Council of Medical Research |
| Funder | Indian Council of Medical Research |
- Submission date
- 07/11/2024
- Registration date
- 08/11/2024
- Last edited
- 08/11/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Stroke is the second leading cause of chronic disability and mortality with 102 million disability-adjusted life years lost annually. The majority of stroke survivors are left with some degree of disability, particularly with upper limb dysfunction. Also, innovative methodologies for restorative neurorehabilitation are required to reduce long-term disability and socioeconomic burden. The use of technology-assisted customized strategies can facilitate a faster recovery process.
Our aim was to develop and test a customized Robotic Exoskeleton to assist flexion and extension of wrist and fingers in a way to improve Activities of Daily Living as assistive technology for a therapeutic benefit that might serve as a relatively more effective and tailored treatment plan for the rehabilitation of wrist and finger joints 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 the 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 the 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 the 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. Indian Institute of Technology, Delhi, India
2. All India Institute of Technology, New Delhi, India
3. Paras Hospital, Gurugram, Haryana, India
When is the study starting and how long is it expected to run for?
April 2020 to March 2028
Who is funding the study?
Indian Council of Medical Research (India)
Who is the main contact?
Dr Amit Mehndiratta, amitvmehndiratta@gmail.com
Contact information
Public, Scientific, Principal investigator
Centre for Biomedical Engineering, Indian Institute of Technology
New-Delhi
110016
India
 ORCID ID |
0000-0001-6477-2462 |
|---|---|
| Phone | +91-11-2659-6230 |
| amehndiratta@cbme.iitd.ac.in |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multi-centric interventional single-blinded randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | CARE-Neuroassistive Technologies for Stroke Recovery |
| Study acronym | CARE-NTS-Robotic |
| Study objectives | Robotic-hand exoskeleton-assisted rehabilitation could show higher improvement of distal upper-limb motor function in patients with stroke as compared to conventional rehabilitation. |
| Ethics approval(s) |
1. Approved 11/04/2020, Institute Ethics Committee (IEC) (Room no. 2, First floor, Old OT Block, All India Institute of Medical Sciences, Ansari Nagar, New-Delhi, 110029, India; +91 11 26594579; ethicscommitteeaiims@gmail.com), ref: IEC-229/11.4.2020 2. Approved 04/10/2024, Paras Hospital, Gurugram (C-1 Sushant Lok- 1 Sector-43 Phase- I, Gurgaon, Haryana, 122002, India; +91 9891418288; narender.s@parashospitals.com), ref: PHPL/PHIEC-COMM/2024/012 |
| Health condition(s) or problem(s) studied | Recovery of post-stroke motor impairments in response to robotic hand-assisted rehabilitation |
| Intervention | Randomized: Manually Duration: 5 days a week for 4 weeks (total 20 sessions) Given by: Therapist at clinic and caregiver at home Settings: Hospital / Home Time points at which outcome measures taken: At baseline, 4 weeks, 3, 6 & 12 months post-therapy Patients with stroke randomized into 3 groups: 1. Comparator Agent: Physiotherapy - The patient will be asked to do clinical physiotherapy as prescribed by the therapist 2. Intervention one: Robotic hand Assisted Therapy at clinic - The patient will be asked to do Robotic hand assisted rehabilitation 3. Intervention two: Robotic hand Assisted Therapy at Home - The patient will be asked to do Robotic hand-assisted rehabilitation at home with the help of a caregiver. Caregiver and patient will be trained before the start of therapy. |
| Intervention type | Device |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | In-house developed Robotic-based upper-limb rehabilitation |
| Primary outcome measure(s) |
1. Spasticity is measured using the Modified Ashworth Scale (MAS) at baseline, 4 weeks, 3 |
| Key secondary outcome measure(s) |
1. TMS Cortical excitability measures i.e., Resting Motor Threshold (RMT), Motor Evoked |
| Completion date | 30/03/2028 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | 1. Age 18-75 years 2. Gender both male and female 3. Patients with stroke chronicity 3-120 months (The groups in 3 month-2 years and 2-10 years will be evaluated post-hoc separately) 4. No previous clinical stroke 5. Single-lesioned, Ischemic / Hemorrhagic Cortical/Sub-cortical stroke type 6. Patient conscious, coherent, comprehendible, cooperative 7. Patient having upper-limb paresis 8. Mini-Mental State Examination (MMSE) score 24-30 9. MRC power 1-3 10. Modified Ashworth Scale 1, 1+, 2, 3 11. Brunnstrom Stage 3-5 12. EMG activity of flexor and extensor compartment of forearm muscle present (even if it is a flicker) 13. Surgical intervention to correct hand deformities e.g., tendon transfers with power quantified through surface EMG |
| Key exclusion criteria | 1. Having progressive neurological disorders 2. Cognitively declining (MMSE < 24) 3. Clinically unstable 4. Contraindications to MRI and TMS procedure 5. Having aphasia 6. Major stroke (NIHSS >16) |
| Date of first enrolment | 01/04/2023 |
| Date of final enrolment | 30/03/2027 |
Locations
Countries of recruitment
- India
Study participating centres
New Delhi
110029
India
Gurgaon, Haryana
122002
India
Delhi
110016
India
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | All data generated or analyzed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
07/11/2024: Trial's existence confirmed by All India Institute of Medical Sciences.
