SlagSens (Effect of Tactile Stimulation After Stroke)

NCT ID: NCT01810562

Last Updated: 2021-04-19

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Specific treatment + std stroke care

Specific treatment in addition to standard stroke care

Group Type EXPERIMENTAL

Specific treatment in addition to standard stroke care

Intervention Type OTHER

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.

Group Type NO_INTERVENTION

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.

Intervention Type OTHER

Other Intervention Names

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Icestimulation Firm pressure Brushing with soft brush Rolling with spiked ball

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vestre Viken Hospital Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Norway

Other Identifiers

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4403 001

Identifier Type: -

Identifier Source: org_study_id

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