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SlagSens (Effect of Tactile Stimulation After Stroke)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01810562
Recruitment Status : Withdrawn (Not able to include enough participants.)
First Posted : March 13, 2013
Last Update Posted : April 19, 2021
Information provided by (Responsible Party):
Vestre Viken Hospital Trust

Brief Summary:

The purpose of this study is to determine whether tactile stimulation for reduced sensibility of the affected extremities after stroke has effect.


Stimulation of sensibility after stroke will have a significant contribution for improved sensibility. Without any stimulation, no signal is sent to the brain and there is no need for the healthy parts of the brain to adapt this function. Stimulation of the sensibility over a period of time on both sides of the body, gives the brain signals and the opportunity to compare how the signals should be recognized. New connection will be able to interpret signals correctly.

Condition or disease Intervention/treatment Phase
Stroke Other: Specific treatment in addition to standard stroke care Not Applicable

Detailed Description:

Through stroke rehabilitation, function from damaged areas can be replaced by healthy parts of the brain. It is important for rehabilitation to take advantage of this compensatory qualities whit early intervention and mobilization. Only small gains can lead to big improvements.

About half of stroke survivors gets reduced sensibility caused bye the stroke, and sensibility is considered to be an important part of rehabilitation of function and activities.

A Norwegian guideline concludes that the scientific knowledge is to week to recommend this kind of treatment. There is some evidence for improvement of sensibility when specific training and stimulation is given. Achievements in sensibility can lead to some improvement in function.

The project will be carried out as a randomized controlled trial. In this project, the intervention group receive tactile senses stimulated twice daily over a period of 3 months, while the control group receives standard treatment. The results from both groups are measured before and after treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Study on Effect of Tactile Stimulation on Reduced Sensibility of the Affected Extremities After Stroke.
Actual Study Start Date : March 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : June 2014

Arm Intervention/treatment
Experimental: Specific treatment + std stroke care
Specific treatment in addition to standard stroke care
Other: Specific treatment in addition to standard stroke care

Stimulation of both the affected side and not affected side. Treatment twice per day for three months. Unperturbed side always stimulated first.

Isstimulering achieved by an ice cube melted on each of the affected ektremitetene evenly distributed.

Brushing on thin clothing or directly on the skin, 10 times rapidly for each location. On the back of m. deltoideus from right to left side of the body, laterally along the humerus, frontally, along the radius / ulna laterally, frontal and dorsal palm, along the femur first laterally and frontally, along the tibia / fibula laterally, frontally and the footplate dorsal side.

Scrolling with spiked ball over the same area as brushing for two minutes evenly.

Firm pressure for two minutes evenly in the same area.

Other Names:
  • Icestimulation
  • Firm pressure
  • Brushing with soft brush
  • Rolling with spiked ball

No Intervention: Std stroke care
Patients receive only standard stroke treatment and no specific treatment.

Primary Outcome Measures :
  1. Weinstein Enhanced sensory test (WEST) [ Time Frame: Change within 3 days after the patient has been hospitalized to 3 months ]
    Measurement of defined points on the arms and legs.

Secondary Outcome Measures :
  1. Disk-Criminator [ Time Frame: Change from 3 days after the patient has been hospitalized to 3 months ]
    Measurement of defined points on the arms and legs.

  2. NIH Stroke Scale (NIHSS) [ Time Frame: Change from Baseline to 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with impaired tactile sensitivity after stroke Kongsberg hospital to undergo rehabilitation course.

Exclusion Criteria:

  • Patients with a history of stroke.
  • Patients with significant symptomatic additional diseases, such as neuropathy.
  • Patients who cannot provide adequate response if they can feel the touch.
  • Terminal and palliative care patients.
  • Patients with cancer.
  • Patients with hypertonic muscles in the current body area.
  • Patients below 18 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01810562

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Vestre Viken Health, clinic Kongsberg Hostpital
Kongsberg, Buskerud, Norway, 3612
Sponsors and Collaborators
Vestre Viken Hospital Trust
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Study Director: Bjørn A Graff, PhD Vestre Viken Hospital Trust
Principal Investigator: Bente Kristensen, BSc Vestre Viken Hospital Trust
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Responsible Party: Vestre Viken Hospital Trust Identifier: NCT01810562    
Other Study ID Numbers: 4403 001
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Keywords provided by Vestre Viken Hospital Trust:
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases