Crossmodal Learning in Therapeutic Processes (Task 2-1)
- Conditions
- Stroke
- Interventions
- Device: Vibro-tactile stimulationOther: Placebo Control
- Registration Number
- NCT05262699
- Lead Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Brief Summary
Interventional study of the effects of vibro-tactile feedback on behavioral deficits and learning during motor training in patients with stroke.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 44
- 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
- Pregnancy
- Lacking capacity for consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stimulation Vibro-tactile stimulation 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 Control 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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).
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 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.
Trial Locations
- Locations (1)
Universitätsklinikum Hamburg-Eppendorf, Neurologie
🇩🇪Hamburg, Germany