Crossmodal Learning in Therapeutic Processes (Task 2-2)

Not Applicable

Terminated

• Conditions: Sensory Ataxia
• Interventions: Other: Placebo Control; Device: Vibro-tactile stimulation

• Registration Number: NCT05262712
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-14
• Study First Submitted: 2022-02-05
• Study First Submitted QC: 2022-03-01
• Study First Posted: 2022-03-02
• Primary Completion: 2023-03-13
• Study Completion: 2023-03-13
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-15
• Last Update Posted: 2023-05-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy
• Lacking capacity for consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo 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.
Stimulation	Vibro-tactile 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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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.

Trial Locations

Locations (1)

Universitätsklinikum Hamburg-Eppendorf, Neurologie; 🇩🇪 Hamburg, Germany