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Effect of Brain Computer Interface robotic therapy in stroke patients

Efficacy of Brain Computer Interface Coupled Robotic Exoskeleton on Chronic Post Stroke Hemiplegic Hand Disability: A Randomized Control Trial - Exoteric trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110557
Enrollment
100
Registered
2026-05-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: I639- Cerebral infarction, unspecified

Interventions

Intervention1: Brain computer interface enabled robotic exoskeleton: The participant will be seated comfortably on a chair, with the hand exoskeleton positioned on a table at an ergonomically appropri

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Post stroke duration 6 to 18 months 2. Montreal Cognitive Assessment (MoCA) score 26 to 30 3. Brunnstrom s hand stage 1to 4 4. ARAT score 0 to 38 5. Can continuously sit for 1.5 hour as inquired from caretaker

Exclusion criteria

Exclusion criteria: 1. Bilateral and recurrent stroke, posterior circulation stroke 2. Additional relevant medical, psychological and musculoskeletal condition like unresolved sepsis; postural hypotension; end stage renal failure, terminal illness, severe aphasia, inattention, hemi spatial neglect; skin infection, eczema, contracture or deformity of upper limb, severe visual impairment, severe depression; psychiatric disorder. 3. Pregnancy 4. Modified ashworth scale grading for finger flexors more than 2. 5. Epilepsy or medication of same during last 6 months 6. Unable to understand and follow instructions. 7. Patients involved in another research trial at the same time, in which intervention may improve upper limb functions. 8. Patients with conditions that is contraindicated for use of transcranial magnetic stimulation i.e. ferromagnetic or magnetic sensitive metal objects implanted in the head or neck areas, epileptic patients, pacemakers, any brain surgery or craniotomy.

Design outcomes

Primary

MeasureTime frame
Action Research Arm Test (ARAT) Timepoint: Before the intervention and after completion of 18 session of intervention

Secondary

MeasureTime frame
1. Feasibility assessment- Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) will be used for examining the feasibility. 2. Grip strength 3. Fugl-Meyer Assessment scale 4. The Stroke Specific Quality Of Life scale (SS-QOL) 5. Beck depression inventory 6. Sollerman hand function test 7.Transcranial magnetic stimulation (TMS)- The motor threshold, amplitude and latency of motor evoked potential will be measured.Timepoint: Before the intervention and after completion of 18 sessions of intervention

Countries

India

Contacts

Public ContactNeetika Katiyar

Post Graduate Institute of Medical Education and Research

khurana.dheeraj@pgimer.edu.in7087009695

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026