Comparison of clinical outcomes of Virtual Reality assisted rehabilitation with dose-matched conventional rehabilitation in patients with stroke

CARE-Neuroassistive Technologies for Stroke recovery

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17494358

Enrollment

100

Registered

2024-02-15

Start date

2020-05-12

Completion date

Unknown

Last updated

2024-02-27

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 the Virtual Reality assisted rehabilitation Nervous System Diseases

Interventions

Randomized: Manually Duration: 5 days a week for 4 weeks (total 20 sessions) Given by: Therapist Settings: Hospital Time points at which outcome measures taken: At baseline, 4 weeks, 3,6 & 12 months p

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 3month-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 EDC 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	—

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

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Secondary

Measure	Time frame
1. TMS Cortical excitability measures i.e., Resting Motor Threshold (RMT), Motor Evoked Potential (MEP), latency at baseline, 4 weeks, 3 months, 6 months and 1 year 2. Functional Neuroimaging (fMRI & DTI) Measures at baseline, 4 weeks, 3 months, 6 months and 1 year. 3. Task-performance measures using time taken to complete, smoothness of trajectory, relative error at baseline and 4 weeks 4. Subjective questionnaire feedback after completion of therapy	—

Measure

Time frame

1. TMS Cortical excitability measures i.e., Resting Motor Threshold (RMT), Motor Evoked Potential (MEP), latency at baseline, 4 weeks, 3 months, 6 months and 1 year 2. Functional Neuroimaging (fMRI & DTI) Measures at baseline, 4 weeks, 3 months, 6 months and 1 year. 3. Task-performance measures using time taken to complete, smoothness of trajectory, relative error at baseline and 4 weeks 4. Subjective questionnaire feedback after completion of therapy

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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