Crossmodal Learning in Therapeutic Processes (Task 2-2)

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 sensory ataxia.

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 2-2)

Conditions
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Sensory Ataxia

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: Electrophysiological diagnosis of sensory ataxia 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 vitro-tactile feedback applied to the feet when touching an object as measured by force-sensing resistors mounted to the sole of the feet. | Device: Vibro-tactile stimulation<br>* Vibro-tactile stimulation will be administered to the feet of participants via C2 tactors (diameter: 3.05 cm, height: 0.79 cm, operating frequency: 200-300 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 feet 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 Timed Up-and Go Test | The Timed Up and Go test is a clinical test to assess a patient's mobility and risk of falling. | 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 10-Meter-Walk Test | The 10-Meter-Walk Test is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility and gait. | One day before (baseline) and one day after seven days of motor training | 
| Change from baseline in Berg-Balance-Scale | The Berg-Balance-Scale (BBS) is used to determine a patient's ability to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. | One day before (baseline) and one day after seven days of motor training | 
| Change from baseline in Postural-Sway Test | The Postural-Sway Test is a common test of quiet stance balance. | 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, Ataxia