Crossmodal Learning in Therapeutic Processes (Task 2-2)

NCT ID: NCT05262712

Last Updated: 2023-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-14

Study Completion Date

2023-03-13

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.

Detailed Description

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Conditions

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Sensory Ataxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Vibro-tactile stimulation

Intervention Type 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/).

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.

Group Type PLACEBO_COMPARATOR

Placebo Control

Intervention Type OTHER

Devices mounted, no stimulation

Interventions

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Vibro-tactile stimulation

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 DEVICE

Placebo Control

Devices mounted, no stimulation

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Research Foundation

OTHER

Sponsor Role collaborator

National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universitätsklinikum Hamburg-Eppendorf, Neurologie

Hamburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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SFB TRR 169/A3 (2-2)

Identifier Type: -

Identifier Source: org_study_id

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