Not provided
Not provided
Not provided
Not provided
Not provided
Unability to include participants during Covid pandemic
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| German Research Foundation | OTHER |
| National Natural Science Foundation of China | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Interventional study of the effects of vibro-tactile feedback on behavioral deficits and learning during motor training in patients with stroke.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stimulation | Experimental | During motor training participants in the stimulation arm receive vibro-tactile feedback applied to their fingers when touching an object as measured by force-sensing resistors mounted to the fingertips. |
|
| Control | Placebo Comparator | The control group receives the same motor training with the same derives (force-sensing resistors, vibro-tactile stimulators) mounted to the hands but receives no stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibro-tactile stimulation | Device | 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/). |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Action Research Arm Test (ARAT) | 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. | One day before (baseline) and one day after seven days of motor training |
| Change from baseline in Nine-hole peg Test (NHPT) | 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. | One day before (baseline) and one day after seven days of motor training |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Fugl-Meyer Assessment for upper extremity (FMA-UE) | 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. | One day before (baseline) and one day after seven days of motor training |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Hamburg-Eppendorf, Neurologie | Hamburg | 20246 | Germany |
Data sharing is planned after main publication of results.
Within 24 months after main publication.
Personal login into UKE data repository.
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
|
| Placebo Control | Other | Devices mounted, no stimulation |
|
| Change from baseline in Stroke Impact Scale (SIS) | 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. | One day before (baseline) and one day after seven days of motor training |
| Change from baseline in National Institutes of Health Stroke Scale (NIHSS) | 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. | One day before (baseline) and one day after seven days of motor training |
| Change from baseline in Modified Rankin Scale (mRS) | 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). | One day before (baseline) and one day after seven days of motor training |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |