Crossmodal Learning in Therapeutic Processes (Task 2-1)

Keywords

• Vibro-tactile stimulation
• Neurorehabilitation
• Stroke

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 403 studies on the registry; 83 are open to participants now.

Study arms

• 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

• 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

Interventions

• DeviceVibro-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/).

• OtherPlacebo Control

  Devices mounted, no stimulation

Primary outcomes

1. 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.

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

2. 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.

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

Secondary outcomes

1. 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.

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

2. 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.

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

3. 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.

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

4. 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).

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

Individual participant data

Plan to share: Yes — Data sharing is planned after main publication of results.

Supporting information: Study protocol