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SlagSens (Effect of Tactile Stimulation After Stroke)

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01810562
Enrollment
0
Registered
2013-03-13
Start date
2013-03-31
Completion date
2014-06-30
Last updated
2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, Tactile, Sensibility, Stimulation, Extremities, Arm, Leg

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.

Interventions

OTHERSpecific 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.

Sponsors

Vestre Viken Hospital Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Weinstein Enhanced sensory test (WEST)Change within 3 days after the patient has been hospitalized to 3 monthsMeasurement of defined points on the arms and legs.

Secondary

MeasureTime frameDescription
Disk-CriminatorChange from 3 days after the patient has been hospitalized to 3 monthsMeasurement of defined points on the arms and legs.
NIH Stroke Scale (NIHSS)Change from Baseline to 3 months

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026