In this study, we want to examine the effect of a new treatment approach for patients with severe upper limb paresis in the subacute phase after stroke. Brain Computer Interface (BCI) driven functional electrical stimulation will be compared to conventional training.
A randomized controlled pilot study will be conducted. Forty patients with severe UL paresis will be included. Patients with severe hemiparesis after stroke will be allocated to one of two treatment groups by a computerized randomization program. Patients in the intervention group will receive training with a BCI system paired with functional electrical stimulation and visual feedback (RecoveriX, gtec, Austria) as part of their rehabilitation. The targeted number of training sessions in the intervention group is 12. Patients in the control group will receive conventional upper limb training. All patients will receive other rehabilitation according to their needs. Patients will be assessed by blinded raters before and after the intervention and 3 months post stroke. Main endpoint will be UL motor function assessed by Action Research Arm Test (ARAT) at 3 months post stroke. Other outcome measures comprise Fugl Meyer Motor Assessment and Functional Independence Measure. The patients and therapists' experience with this type of training will be evaluated with questionnaires and interviews.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Training with RecoveriX system.
Standard physiotherapy and occupational therapy according to clinical routines.
Hammel Neurorehabilitation Centre and University Research Clinic
Hammel, Aarhus, Denmark
Action Research Arm Test (ARAT)
Upper limb function on a scale of 0 - 57 (best)
Time frame: Upper limb function 90 days after stroke
Fugl-Meyer Assessment (UL)
Upper limb impairment on a scale from 0-66 (best)
Time frame: Upper limb impairment 90 days after stroke
Functional Independence Measure
Independence in activities og daily living, 18-126 (best)
Time frame: Functional independence 90 days after stroke
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.