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Robotic hand therapy for rehabilitation after brain damage caused by stroke

CARE-Neuroassistive Technologies for Stroke Recovery

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN28431480
Enrollment
200
Registered
2024-11-08
Start date
2023-04-01
Completion date
Unknown
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recovery of post-stroke motor impairments in response to robotic hand-assisted rehabilitation Nervous System Diseases

Interventions

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:

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Having progressive neurological disorders 2. Cognitively declining (MMSE 16)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

India

Contacts

Public ContactAmit Mehndiratta
amehndiratta@cbme.iitd.ac.in+91-11-2659-6230

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026