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Crossmodal Learning in Therapeutic Processes (Task 2-2)

Primary Purpose

Sensory Ataxia

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Vibro-tactile stimulation
Placebo Control
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sensory Ataxia focused on measuring Vibro-tactile Stimulation, Neurorehabilitation, Ataxia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Electrophysiological diagnosis of sensory ataxia
  • Age >= 18, <=80
  • Existing declaration of consent

Exclusion Criteria:

  • Pregnancy
  • Lacking capacity for consent

Sites / Locations

  • Universitätsklinikum Hamburg-Eppendorf, Neurologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Stimulation

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Change from baseline in Postural-Sway Test
The Postural-Sway Test is a common test of quiet stance balance.

Full Information

First Posted
February 5, 2022
Last Updated
May 15, 2023
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
German Research Foundation, National Natural Science Foundation of China
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1. Study Identification

Unique Protocol Identification Number
NCT05262712
Brief Title
Crossmodal Learning in Therapeutic Processes (Task 2-2)
Official Title
SFB TRR 169/A3 (2.FP) Crossmodal Learning in Health and Neurological Disease: Neurocomputational Representation and Therapeutic Application (Task 2-2)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Unability to reach anticipated participant numbers during COVID pandemic
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
March 13, 2023 (Actual)
Study Completion Date
March 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
German Research Foundation, National Natural Science Foundation of China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensory Ataxia
Keywords
Vibro-tactile Stimulation, Neurorehabilitation, Ataxia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Vibro-tactile stimulation
Intervention Description
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/).
Intervention Type
Other
Intervention Name(s)
Placebo Control
Intervention Description
Devices mounted, no stimulation
Primary Outcome Measure Information:
Title
Change from baseline in Timed Up-and Go Test
Description
The Timed "Up and Go" test is a clinical test to assess a patient's mobility and risk of falling.
Time Frame
One day before (baseline) and one day after seven days of motor training
Secondary Outcome Measure Information:
Title
Change from baseline in 10-Meter-Walk Test
Description
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.
Time Frame
One day before (baseline) and one day after seven days of motor training
Title
Change from baseline in Berg-Balance-Scale
Description
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.
Time Frame
One day before (baseline) and one day after seven days of motor training
Title
Change from baseline in Postural-Sway Test
Description
The Postural-Sway Test is a common test of quiet stance balance.
Time Frame
One day before (baseline) and one day after seven days of motor training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Electrophysiological diagnosis of sensory ataxia Age >= 18, <=80 Existing declaration of consent Exclusion Criteria: Pregnancy Lacking capacity for consent
Facility Information:
Facility Name
Universitätsklinikum Hamburg-Eppendorf, Neurologie
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Crossmodal Learning in Therapeutic Processes (Task 2-2)

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