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Unability to reach anticipated participant numbers during COVID pandemic
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| Name | Class |
|---|---|
| German Research Foundation | OTHER |
| National Natural Science Foundation of China | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stimulation | Experimental | 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. |
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| Control | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibro-tactile stimulation | Device | 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/). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| 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.
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| ID | Term |
|---|---|
| D001259 | Ataxia |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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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.
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| Placebo Control | Other | Devices mounted, no stimulation |
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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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |