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SlagSens (Effect of Tactile Stimulation After Stroke)

Primary Purpose

Stroke

Status
Withdrawn
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Specific treatment in addition to standard stroke care
Sponsored by
Vestre Viken Hospital Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stroke focused on measuring Stroke, Tactile, Sensibility, Stimulation, Extremities, Arm, Leg

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vestre Viken Health, clinic Kongsberg Hostpital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Specific treatment + std stroke care

Std stroke care

Arm Description

Specific treatment in addition to standard stroke care

Patients receive only standard stroke treatment and no specific treatment.

Outcomes

Primary Outcome Measures

Weinstein Enhanced sensory test (WEST)
Measurement of defined points on the arms and legs.

Secondary Outcome Measures

Disk-Criminator
Measurement of defined points on the arms and legs.
NIH Stroke Scale (NIHSS)

Full Information

First Posted
March 5, 2013
Last Updated
April 13, 2021
Sponsor
Vestre Viken Hospital Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01810562
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Not able to include enough participants.
Study Start Date
March 2013 (Actual)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vestre Viken Hospital Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Tactile, Sensibility, Stimulation, Extremities, Arm, Leg

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Specific treatment + std stroke care
Arm Type
Experimental
Arm Description
Specific treatment in addition to standard stroke care
Arm Title
Std stroke care
Arm Type
No Intervention
Arm Description
Patients receive only standard stroke treatment and no specific treatment.
Intervention Type
Other
Intervention Name(s)
Specific treatment in addition to standard stroke care
Other Intervention Name(s)
Icestimulation, Firm pressure, Brushing with soft brush, Rolling with spiked ball
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weinstein Enhanced sensory test (WEST)
Description
Measurement of defined points on the arms and legs.
Time Frame
Change within 3 days after the patient has been hospitalized to 3 months
Secondary Outcome Measure Information:
Title
Disk-Criminator
Description
Measurement of defined points on the arms and legs.
Time Frame
Change from 3 days after the patient has been hospitalized to 3 months
Title
NIH Stroke Scale (NIHSS)
Time Frame
Change from Baseline to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bjørn A Graff, PhD
Organizational Affiliation
Vestre Viken Hospital Trust
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bente Kristensen, BSc
Organizational Affiliation
Vestre Viken Hospital Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vestre Viken Health, clinic Kongsberg Hostpital
City
Kongsberg
State/Province
Buskerud
ZIP/Postal Code
3612
Country
Norway

12. IPD Sharing Statement

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SlagSens (Effect of Tactile Stimulation After Stroke)

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