Stroke
Conditions
Keywords
Vibro-tactile stimulation, Neurorehabilitation, Stroke
Brief summary
Interventional study of the effects of vibro-tactile feedback on behavioral deficits and learning during motor training in patients with stroke.
Interventions
OTHERPlacebo Control
Devices mounted, no stimulation
Vibro-tactile stimulation will be administered to the fingers of the participants via C3 tactors (diameter: 2.03 cm, height: 0.64 cm, operating frequency: 180-320 Hz, see https://www.eaiinfo.com/tactor-info/). Vibro-tactile stimulation will be triggered by force-sensing resistors (TEA CAPTIV T-SENS FSR, see https://www.teaergo.com/products/tea-captiv-t-sens-fsr/).
Sponsors
German Research Foundation
National Natural Science Foundation of China
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Assessment, motor training, data analyzes, and group allocation are done by different persons. Participants as well as the assessor, the trainer and the investigator are blinded to the group allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Ischemic stroke according to ICD 10 I61-I69 * Deficit still existing (Rankin score of at least 1 at inclusion) * Age \>= 18, \<=80 * Existing declaration of consent
Exclusion criteria
* Pregnancy * Lacking capacity for consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Action Research Arm Test (ARAT) | One day before (baseline) and one day after seven days of motor training | The Action Research Arm Test (ARAT) is a 19 item observational measure to assess upper extremity performance (coordination, dexterity and functioning). Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally). Scores may range from 0-57 points, with higher points indicating better performance. |
| Change from baseline in Nine-hole peg Test (NHPT) | One day before (baseline) and one day after seven days of motor training | A timed measure of fine manual dexterity where the patient is instructed to first take nine pegs out of a container and place them afterwards back into the empty holes of the container as quickly as possible. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Fugl-Meyer Assessment for upper extremity (FMA-UE) | One day before (baseline) and one day after seven days of motor training | The section motor function of upper limb is one of five domains, a three-point scale is used for rating performance as 0=cannot perform, 1=performs partially and 2=performs fully, max. possible score: 66 points. |
| Change from baseline in Stroke Impact Scale (SIS) | One day before (baseline) and one day after seven days of motor training | Measurement of subjective stroke-specific health status, 64 items in eight domains, domain scores range between 0-100, with higher scores represent better health status. |
| Change from baseline in National Institutes of Health Stroke Scale (NIHSS) | One day before (baseline) and one day after seven days of motor training | The National Institutes of Health Stroke Scale, NIHSS, is a score system to quantify the impairment caused by a stroke. The sum of the values from the investigations results in a maximum of 42 points. The higher the score, the more extensive the stroke. |
| Change from baseline in Modified Rankin Scale (mRS) | One day before (baseline) and one day after seven days of motor training | The modified Rankin scale (MRS) is a standardized measure that describes the extent of disability after a stroke. It ranges from 0 (no symptoms) to 6 (death due to stroke). |
Countries
Germany
Outcome results
None listed