Crossmodal Learning in Therapeutic Processes (Task 2-1)

SFB TRR 169/A3 (2.FP) Crossmodal Learning in Health and Neurological Disease: Neurocomputational Representation and Therapeutic Application (Task 2-1)

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

Study Overview

• Status: Suspended
• Conditions: Stroke
• Intervention / Treatment: Device: Vibro-tactile stimulation; Other: Placebo Control

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christian Gerloff, Prof. Dr.; Phone Number: +49 (0) 40 7410 - 52770; Email: gerloff@uke.de
• Study Contact Backup: Name: Focko L. Higgen, Dr.; Phone Number: +49 (0) 40 7410 - 55531; Email: f.higgen@uke.de

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg-Eppendorf, Neurologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ischemic stroke according to ICD 10 I61-I69
• Deficit still existing (Rankin score of at least 1 at inclusion)
• Age >= 18, <=80
• Existing declaration of consent

Exclusion Criteria:

• Pregnancy
• Lacking capacity for consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stimulation; During motor training participants in the stimulation arm receive vibro-tactile feedback applied to their fingers when touching an object as measured by force-sensing resistors mounted to the fingertips.	Device: Vibro-tactile stimulation; Vibro-tactile stimulation will be administered to the fingers of the participants via C3 tactors (diameter: 2.03 cm, height: 0.64 cm, operating frequency: 180-320 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 hands but receives no stimulation.	Other: Placebo Control; Devices mounted, no stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Action Research Arm Test (ARAT)	The Action Research Arm Test (ARAT) is a 19 item observational measure to assess upper extremity performance (coordination, dexterity and functioning). Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally). Scores may range from 0-57 points, with higher points indicating better performance.	One day before (baseline) and one day after seven days of motor training
Change from baseline in Nine-hole peg Test (NHPT)	A timed measure of fine manual dexterity where the patient is instructed to first take nine pegs out of a container and place them afterwards back into the empty holes of the container as quickly as possible.	One day before (baseline) and one day after seven days of motor training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Fugl-Meyer Assessment for upper extremity (FMA-UE)	The section motor function of upper limb is one of five domains, a three-point scale is used for rating performance as 0=cannot perform, 1=performs partially and 2=performs fully, max. possible score: 66 points.	One day before (baseline) and one day after seven days of motor training
Change from baseline in Stroke Impact Scale (SIS)	Measurement of subjective stroke-specific health status, 64 items in eight domains, domain scores range between 0-100, with higher scores represent better health status.	One day before (baseline) and one day after seven days of motor training
Change from baseline in National Institutes of Health Stroke Scale (NIHSS)	The National Institutes of Health Stroke Scale, NIHSS, is a score system to quantify the impairment caused by a stroke. The sum of the values from the investigations results in a maximum of 42 points. The higher the score, the more extensive the stroke.	One day before (baseline) and one day after seven days of motor training
Change from baseline in Modified Rankin Scale (mRS)	The modified Rankin scale (MRS) is a standardized measure that describes the extent of disability after a stroke. It ranges from 0 (no symptoms) to 6 (death due to stroke).	One day before (baseline) and one day after seven days of motor training

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: National Natural Science Foundation of China; German Research Foundation

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2021
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: February 5, 2022
• First Submitted That Met QC Criteria: March 1, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 21, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; Neurorehabilitation; Vibro-tactile stimulation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: SFB TRR 169/A3 (2-1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No