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Crossmodal Learning in Therapeutic Processes (Task 2-1)

Primary Purpose

Stroke

Status
Suspended
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Vibro-tactile stimulation
Placebo Control
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Vibro-tactile stimulation, Neurorehabilitation, Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsklinikum Hamburg-Eppendorf, Neurologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Stimulation

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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).

Full Information

First Posted
February 5, 2022
Last Updated
May 21, 2023
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
German Research Foundation, National Natural Science Foundation of China
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1. Study Identification

Unique Protocol Identification Number
NCT05262699
Brief Title
Crossmodal Learning in Therapeutic Processes (Task 2-1)
Official Title
SFB TRR 169/A3 (2.FP) Crossmodal Learning in Health and Neurological Disease: Neurocomputational Representation and Therapeutic Application (Task 2-1)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Suspended
Why Stopped
Unability to include participants during Covid pandemic
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
German Research Foundation, National Natural Science Foundation of China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Vibro-tactile stimulation, Neurorehabilitation, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Vibro-tactile stimulation
Intervention Description
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/).
Intervention Type
Other
Intervention Name(s)
Placebo Control
Intervention Description
Devices mounted, no stimulation
Primary Outcome Measure Information:
Title
Change from baseline in Action Research Arm Test (ARAT)
Description
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.
Time Frame
One day before (baseline) and one day after seven days of motor training
Title
Change from baseline in Nine-hole peg Test (NHPT)
Description
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.
Time Frame
One day before (baseline) and one day after seven days of motor training
Secondary Outcome Measure Information:
Title
Change from baseline in Fugl-Meyer Assessment for upper extremity (FMA-UE)
Description
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.
Time Frame
One day before (baseline) and one day after seven days of motor training
Title
Change from baseline in Stroke Impact Scale (SIS)
Description
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.
Time Frame
One day before (baseline) and one day after seven days of motor training
Title
Change from baseline in National Institutes of Health Stroke Scale (NIHSS)
Description
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.
Time Frame
One day before (baseline) and one day after seven days of motor training
Title
Change from baseline in Modified Rankin Scale (mRS)
Description
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).
Time Frame
One day before (baseline) and one day after seven days of motor training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Universitätsklinikum Hamburg-Eppendorf, Neurologie
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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Crossmodal Learning in Therapeutic Processes (Task 2-1)

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