SlagSens (Effect of Tactile Stimulation After Stroke)

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01810562
• Other study ID #: 4403 001
• Status: Withdrawn
• Phase: N/A
• Start date: March 2013
• Est. completion date: June 2014

Study information

• Verified date: April 2021
• Source: Vestre Viken Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Norway	Vestre Viken Health, clinic Kongsberg Hostpital	Kongsberg	Buskerud

Sponsors (1)

Lead Sponsor	Collaborator
Vestre Viken Hospital Trust

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weinstein Enhanced sensory test (WEST)	Measurement of defined points on the arms and legs.	Change within 3 days after the patient has been hospitalized to 3 months
Secondary	Disk-Criminator	Measurement of defined points on the arms and legs.	Change from 3 days after the patient has been hospitalized to 3 months
Secondary	NIH Stroke Scale (NIHSS)		Change from Baseline to 3 months