Crossmodal Learning in Therapeutic Processes (Task 2-1)

Study Overview
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Brief Summary
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Interventional study of the effects of vibro-tactile feedback on behavioral deficits and learning during motor training in patients with stroke.

Official Title
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SFB TRR 169/A3 (2.FP) Crossmodal Learning in Health and Neurological Disease: Neurocomputational Representation and Therapeutic Application (Task 2-1)

Conditions
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Stroke

Intervention / Treatment
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* Device: Vibro-tactile stimulation
* Other: Placebo Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stimulation<br>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. | Device: Vibro-tactile stimulation<br>* 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/).<br>|
| Placebo Comparator: Control<br>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. | Other: Placebo Control<br>* Devices mounted, no stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vibro-tactile stimulation, Neurorehabilitation, Stroke