SlagSens (Effect of Tactile Stimulation After Stroke)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Vestre Viken Hospital Trust
Sponsor:
Information provided by (Responsible Party):
Vestre Viken Hospital Trust
ClinicalTrials.gov Identifier:
NCT01810562
First received: March 5, 2013
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Stroke
Other: Specific treatment in addition to standard stroke care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Study on Effect of Tactile Stimulation on Reduced Sensibility of the Affected Extremities After Stroke.

Further study details as provided by Vestre Viken Hospital Trust:

Primary Outcome Measures:
  • Weinstein Enhanced sensory test (WEST) [ Time Frame: Change within 3 days after the patient has been hospitalized to 3 months ] [ Designated as safety issue: No ]
    Measurement of defined points on the arms and legs.


Secondary Outcome Measures:
  • Disk-Criminator [ Time Frame: Change from 3 days after the patient has been hospitalized to 3 months ] [ Designated as safety issue: No ]
    Measurement of defined points on the arms and legs.

  • NIH Stroke Scale (NIHSS) [ Time Frame: Change from Baseline to 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: March 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01810562

Locations
Norway
Vestre Viken Health, clinic Kongsberg Hostpital Recruiting
Kongsberg, Buskerud, Norway, 3612
Contact: VestreViken HF    +47 32 86 11 00    postmottak@vestreviken.no   
Principal Investigator: Bente Kristensen         
Sponsors and Collaborators
Vestre Viken Hospital Trust
Investigators
Study Director: Bjørn A Graff, PhD Vestre Viken Hospital Trust
Principal Investigator: Bente Kristensen, BSc Vestre Viken Hospital Trust
  More Information

No publications provided

Responsible Party: Vestre Viken Hospital Trust
ClinicalTrials.gov Identifier: NCT01810562     History of Changes
Other Study ID Numbers: 4403 001
Study First Received: March 5, 2013
Last Updated: April 3, 2013
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Vestre Viken Hospital Trust:
Stroke
Tactile
Sensibility
Stimulation
Extremities
Arm
Leg

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014