Robotic hand therapy for rehabilitation after brain damage caused by stroke

ISRCTN	ISRCTN28431480
DOI	https://doi.org/10.1186/ISRCTN28431480
Secondary identifying numbers	55/4/1/CARE-Disability & AT/2020/NCD-II

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Dr Amit Mehndiratta
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
Email	amehndiratta@cbme.iitd.ac.in

Study information

Study design	Multi-centric interventional single-blinded randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Home, Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a 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
Pharmaceutical study type(s)	Not Applicable
Phase	Phase III
Drug / device / biological / vaccine name(s)	In-house developed Robotic-based upper-limb rehabilitation
Primary outcome measure	1. Spasticity is measured using the Modified Ashworth Scale (MAS) at baseline, 4 weeks, 3 months, 6 months and 1 year 2. Motor functionality is measured using Fugl-Meyer Assessment (FMA), Active and Passive Range of Motion (AROM and PROM), Motor Assessment Scale at baseline, 4 weeks, 3 months, 6 months and 1 year 3. Stage of recovery using Bruunstrom Stage (BS) at baseline, 4 weeks, 3 months, 6 months and 1 year 4. Activities of Daily Living (ADL) participation using Modified Barthel Index (MBI) at baseline, 4 weeks, 3 months, 6 months, and 1 year 5. Disability level by Modified Rankin Scale (MRS) at baseline, 4 weeks, 3 months, 6 months and 1 year 6. Hand laterality measured by Edinburg scale of laterality index at baseline, 4 weeks, 3 months, 6 months and 1 year 7. Muscle power using Muscle Research Council (MRC) scale at baseline, 4 weeks, 3 months, 6 months and 1 year 8. Modified Barthel index (mBI) t baseline, 4 weeks, 3 months, 6 months and 1 year 9. Stroke Impact Scale (SIS) at baseline, 4 weeks, 3 months, 6 months and 1 year 10. Motor Activity LOG (MAL) at baseline, 4 weeks, 3 months, 6 months and 1 year 11. Action Research Arm Test (ARAT) at baseline, 4 weeks, 3 months, 6 months and 1 year
Secondary outcome measures	1. TMS Cortical excitability measures i.e., Resting Motor Threshold (RMT), Motor Evoked Potential (MEP), latency at five different time points 2. Functional Neuroimaging (fMRI & DTI) Measures at five different time points 3. Electromyography (EMG) at five different time points 4. Motor Assessment Scale (MoAS) at five different time points 5. Subjective questionnaire feedback after completion of therapy after the completion of the therapy sessions 6. System Usability scale after the completion of the therapy sessions
Overall study start date	11/04/2020
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	Both
Target number of participants	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

All India Institute of Medical Sciences New Delhi Ansari Nagar

South west Delhi
New Delhi
110029
India

Paras Hospital, Gurugram

C-1 Sushant Lok- 1 Sector-43 Phase- I
Gurgaon, Haryana
122002
India

Indian Institute of Technology, Delhi

IIT Campus, Hauz Khas, Delhi
Delhi
110016
India

Sponsor information

Indian Council of Medical Research
Government

V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar
New Delhi
110029
India

Phone	+91-11-26594579
Email	icmrhqds@sansad.nic.in
Website	http://www.icmr.nic.in/
"ROR"	https://ror.org/0492wrx28

Funders

Funder type

Government

Indian Council of Medical Research
Government organisation / National government

Alternative name(s): Indian Council of Medical Research, Government of India, Indian Council of Medical Research (ICMR), New Delhi, ICMROrganisation, भारतीय चिकित्सा अनुसंधान परिषद, Indian Council of Medical Research, New Delhi, ICMR, ICMRDELHI, आई.सी.एम.आर
Location: India

Results and Publications

Intention to publish date	01/01/2026
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Published as a supplement to the results publication
Publication and dissemination plan	Planned publication in a high-impact journal.
IPD sharing plan	All data generated or analyzed during this study will be included in the subsequent results publication.

Editorial Notes

07/11/2024: Trial's existence confirmed by All India Institute of Medical Sciences.