SlagSens (Effect of Tactile Stimulation After Stroke)
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|ClinicalTrials.gov Identifier: NCT01810562|
Recruitment Status : Unknown
Verified April 2013 by Vestre Viken Hospital Trust.
Recruitment status was: Recruiting
First Posted : March 13, 2013
Last Update Posted : April 4, 2013
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|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.|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||April 2014|
|Estimated Study Completion Date :||June 2014|
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.
No Intervention: Std stroke care
Patients receive only standard stroke treatment and no specific treatment.
- 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.
- 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.
- NIH Stroke Scale (NIHSS) [ Time Frame: Change from Baseline to 3 months ]
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 ClinicalTrials.gov identifier (NCT number): NCT01810562
|Vestre Viken Health, clinic Kongsberg Hostpital||Recruiting|
|Kongsberg, Buskerud, Norway, 3612|
|Contact: VestreViken HF +47 32 86 11 00 firstname.lastname@example.org|
|Principal Investigator: Bente Kristensen|
|Study Director:||Bjørn A Graff, PhD||Vestre Viken Hospital Trust|
|Principal Investigator:||Bente Kristensen, BSc||Vestre Viken Hospital Trust|