Crossmodal Learning in Therapeutic Processes (Task 2-2)
May 15, 2023 updated by: Universitätsklinikum Hamburg-Eppendorf
SFB TRR 169/A3 (2.FP) Crossmodal Learning in Health and Neurological Disease: Neurocomputational Representation and Therapeutic Application (Task 2-2)
Interventional study of the effects of vibro-tactile feedback on behavioral deficits and learning during motor training in patients with sensory ataxia.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hamburg, Germany, 20246
- Universitätsklinikum Hamburg-Eppendorf, Neurologie
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Electrophysiological diagnosis of sensory ataxia
- Age >= 18, <=80
- Existing declaration of consent
Exclusion Criteria:
- Pregnancy
- Lacking capacity for consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Stimulation
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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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/).
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Placebo Comparator: Control
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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Devices mounted, no stimulation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change from baseline in Timed Up-and Go Test
Time Frame: One day before (baseline) and one day after seven days of motor training
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The Timed "Up and Go" test is a clinical test to assess a patient's mobility and risk of falling.
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One day before (baseline) and one day after seven days of motor training
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change from baseline in 10-Meter-Walk Test
Time Frame: One day before (baseline) and one day after seven days of motor training
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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.
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One day before (baseline) and one day after seven days of motor training
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Change from baseline in Berg-Balance-Scale
Time Frame: One day before (baseline) and one day after seven days of motor training
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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.
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One day before (baseline) and one day after seven days of motor training
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Change from baseline in Postural-Sway Test
Time Frame: One day before (baseline) and one day after seven days of motor training
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The Postural-Sway Test is a common test of quiet stance balance.
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One day before (baseline) and one day after seven days of motor training
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 14, 2021
Primary Completion (Actual)
March 13, 2023
Study Completion (Actual)
March 13, 2023
Study Registration Dates
First Submitted
February 5, 2022
First Submitted That Met QC Criteria
March 1, 2022
First Posted (Actual)
March 2, 2022
Study Record Updates
Last Update Posted (Actual)
May 17, 2023
Last Update Submitted That Met QC Criteria
May 15, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SFB TRR 169/A3 (2-2)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data sharing is planned after main publication of results.
IPD Sharing Time Frame
Within 24 months after main publication.
IPD Sharing Access Criteria
Personal login into UKE data repository.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.