SlagSens (Effect of Tactile Stimulation After Stroke)

Not Applicable

Withdrawn

• Conditions: Stroke
• Interventions: Other: Specific treatment in addition to standard stroke care

• Registration Number: NCT01810562
• Lead Sponsor: Vestre Viken Hospital Trust

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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-05
• Study First Submitted QC: 2013-03-11
• Study First Posted: 2013-03-13
• Primary Completion: 2014-04
• Study Completion: 2014-06
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-13
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Specific treatment + std stroke care	Specific treatment in addition to standard stroke care	Specific treatment in addition to standard stroke care

Primary Outcome Measures

Name	Time	Method
Weinstein Enhanced sensory test (WEST)	Change within 3 days after the patient has been hospitalized to 3 months	Measurement of defined points on the arms and legs.

Secondary Outcome Measures

Name	Time	Method
Disk-Criminator	Change from 3 days after the patient has been hospitalized to 3 months	Measurement of defined points on the arms and legs.
NIH Stroke Scale (NIHSS)	Change from Baseline to 3 months

Trial Locations

Locations (1)

Vestre Viken Health, clinic Kongsberg Hostpital; 🇳🇴 Kongsberg, Buskerud, Norway