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Clinical Trials/NCT01810562
NCT01810562
Withdrawn
Not Applicable

Study on Effect of Tactile Stimulation on Reduced Sensibility of the Affected Extremities After Stroke.

Vestre Viken Hospital Trust1 site in 1 countryMarch 2013
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Vestre Viken Hospital Trust
Locations
1
Primary Endpoint
Weinstein Enhanced sensory test (WEST)
Status
Withdrawn
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
June 2014
Last Updated
5 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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 Outcomes

  • Disk-Criminator(Change from 3 days after the patient has been hospitalized to 3 months)
  • NIH Stroke Scale (NIHSS)(Change from Baseline to 3 months)

Study Sites (1)

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