Crossmodal Learning in Therapeutic Processes (Task 2-2)

NCT05262712 | Terminated

• 1 other identifier: SFB TRR 169/A3 (2-2)
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sensory Ataxia

Keywords

Vibro-tactile Stimulation; Neurorehabilitation; Ataxia

Outcome Measures

Primary Outcomes (1)

• 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.

  One day before (baseline) and one day after seven days of motor training

Secondary Outcomes (3)

• Change from baseline in 10-Meter-Walk Test

  One day before (baseline) and one day after seven days of motor training

• Change from baseline in Berg-Balance-Scale

  One day before (baseline) and one day after seven days of motor training

• Change from baseline in Postural-Sway Test

  One day before (baseline) and one day after seven days of motor training

Study Arms (2)

Stimulation

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

Vibro-tactile stimulation 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/).

Stimulation

Placebo Control OTHER

Devices mounted, no stimulation

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy
• Lacking capacity for consent

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• German Research Foundation: collaborator
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Universitätsklinikum Hamburg-Eppendorf, Neurologie

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Ataxia

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2022
• First Posted: March 2, 2022
• Study Start: April 14, 2021
• Primary Completion: March 13, 2023
• Study Completion: March 13, 2023
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 24 months after main publication.
• Access Criteria: Personal login into UKE data repository.

Locations

DE (1)