Recovery of post-stroke motor impairments in response to robotic hand-assisted rehabilitation Nervous System Diseases
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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