Crossmodal Learning in Therapeutic Processes (Task 2-2)

Sponsor

Universitätsklinikum Hamburg-Eppendorf (Other)

Overall Status

Recruiting

CT.gov ID

NCT05262712

Collaborator

German Research Foundation (Other), National Natural Science Foundation of China (Other)

Enrollment

Location

Arms

31.6

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sensory Ataxia	Device: Vibro-tactile stimulation Other: Placebo Control	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose:

Treatment

Official Title:

SFB TRR 169/A3 (2.FP) Crossmodal Learning in Health and Neurological Disease: Neurocomputational Representation and Therapeutic Application (Task 2-2)

Actual Study Start Date :

Apr 14, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: 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/).
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.	Other: Placebo Control Devices mounted, no stimulation

Arm

Intervention/Treatment

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.

Device: 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/).

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.

Other: Placebo Control

Devices mounted, no stimulation

Outcome Measures

Primary Outcome Measures

Change from baseline in Timed Up-and Go Test [One day before (baseline) and one day after seven days of motor training]
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 [One day before (baseline) and one day after seven days of motor training]
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 [One day before (baseline) and one day after seven days of motor training]
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 [One day before (baseline) and one day after seven days of motor training]
The Postural-Sway Test is a common test of quiet stance balance.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Pregnancy
Lacking capacity for consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinikum Hamburg-Eppendorf, Neurologie	Hamburg		Germany	20246

Sponsors and Collaborators

Universitätsklinikum Hamburg-Eppendorf
German Research Foundation
National Natural Science Foundation of China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universitätsklinikum Hamburg-Eppendorf

ClinicalTrials.gov Identifier:

NCT05262712

Other Study ID Numbers:

SFB TRR 169/A3 (2-2)

First Posted:

Mar 2, 2022

Last Update Posted:

Mar 2, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Universitätsklinikum Hamburg-Eppendorf

Vibro-tactile Stimulation

Neurorehabilitation

Ataxia

Additional relevant MeSH terms:

Ataxia

Study Results

No Results Posted as of Mar 2, 2022