SlagSens (Effect of Tactile Stimulation After Stroke)

April 13, 2021 updated by: Vestre Viken Hospital Trust

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Buskerud
      • Kongsberg, Buskerud, Norway, 3612
        • Vestre Viken Health, clinic Kongsberg Hostpital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change within 3 days after the patient has been hospitalized to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from 3 days after the patient has been hospitalized to 3 months
NIH Stroke Scale (NIHSS)
Time Frame: Change from Baseline to 3 months
Change from Baseline to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vestre Viken Hospital Trust

Investigators

  • Study Director: Bjørn A Graff, PhD, Vestre Viken Hospital Trust
  • Principal Investigator: Bente Kristensen, BSc, Vestre Viken Hospital Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2013

Primary Completion (ACTUAL)

April 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

March 5, 2013

First Submitted That Met QC Criteria

March 11, 2013

First Posted (ESTIMATE)

March 13, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 13, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4403 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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