Clinical trial NCT01810562: SlagSens (Effect of Tactile Stimulation After Stroke)
Official title: Study on Effect of Tactile Stimulation on Reduced Sensibility of the Affected Extremities After Stroke.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke
Keywords: Stroke
Tactile
Sensibility
Stimulation
Extremities
Arm
Leg
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
First posted: 2013-03-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weinstein Enhanced sensory test (WEST)
timeFrame: Change within 3 days after the patient has been hospitalized to 3 months
Secondary outcomes:
measure: Disk-Criminator
timeFrame: Change from 3 days after the patient has been hospitalized to 3 months
measure: NIH Stroke Scale (NIHSS)
timeFrame: Change from Baseline to 3 months
Other outcomes:
Locations:
city: Kongsberg
country: Norway
facility: Vestre Viken Health, clinic Kongsberg Hostpital
state: Buskerud
Study officials:
affiliation: Vestre Viken Hospital Trust
name: Bjørn A Graff, PhD
role: STUDY_DIRECTOR
affiliation: Vestre Viken Hospital Trust
name: Bente Kristensen, BSc
role: PRINCIPAL_INVESTIGATOR
References: