Crossmodal Learning in Therapeutic Processes (Task 2-1)

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05262699
• Other study ID #: SFB TRR 169/A3 (2-1)
• Status: Suspended
• Phase: N/A
• Start date: April 14, 2021
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 44
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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/).

Other:
• Placebo Control
Devices mounted, no stimulation

Locations

Country	Name	City	State
Germany	Universitätsklinikum Hamburg-Eppendorf, Neurologie	Hamburg

Sponsors (3)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	German Research Foundation, National Natural Science Foundation of China

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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