Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2013-03-31
2014-06-30
Brief Summary
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Hypothesis:
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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
BASIC_SCIENCE
SINGLE
Study Groups
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Specific treatment + std stroke care
Specific treatment in addition to standard stroke care
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.
Std stroke care
Patients receive only standard stroke treatment and no specific treatment.
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Vestre Viken Hospital Trust
OTHER
Responsible Party
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Principal Investigators
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Bjørn A Graff, PhD
Role: STUDY_DIRECTOR
Vestre Viken Hospital Trust
Bente Kristensen, BSc
Role: PRINCIPAL_INVESTIGATOR
Vestre Viken Hospital Trust
Locations
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Vestre Viken Health, clinic Kongsberg Hostpital
Kongsberg, Buskerud, Norway
Countries
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Other Identifiers
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4403 001
Identifier Type: -
Identifier Source: org_study_id
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