Stroke
Conditions
Keywords
BCI, upper limb, severe paresis, subacute stroke, rehabilitation
Brief summary
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.
Detailed description
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.
Interventions
DEVICEBrain Computer Interface training
Training with RecoveriX system.
BEHAVIORALControl
Standard physiotherapy and occupational therapy according to clinical routines.
Sponsors
Hammel Neurorehabilitation Centre and University Research Clinic
Sygekassernes Helsefond
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
All assessments will be done by assessors blinded to treatment allocation.
Intervention model description
Patients are randomized to one of two treatment options, intervention or standard rehabilitation
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* First ever or former stroke without UL motor residuals as confirmed by CT and / or MRI * 15 days to 60 days (+/- 3) after stroke onset * Severe paresis or paralysis defined as \< 13 on Action Research arm Test (ARAT) * Able to give informed consent * Able to comply with treatment protocol.
Exclusion criteria
* Other conditions limiting functional use of the affected UL, * Psychiatric / behavioral conditions that interfere with compliance to the protocol, epilepsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Action Research Arm Test (ARAT) | Upper limb function 90 days after stroke | Upper limb function on a scale of 0 - 57 (best) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment (UL) | Upper limb impairment 90 days after stroke | Upper limb impairment on a scale from 0-66 (best) |
| Functional Independence Measure | Functional independence 90 days after stroke | Independence in activities og daily living, 18-126 (best) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Interviews | Through study completion, an average of 6 months | Qualitative assessment of user experiences |
Countries
Denmark
Outcome results
None listed