NCT01810562

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 13, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

April 19, 2021

Status Verified

April 1, 2021

Enrollment Period

1.1 years

First QC Date

March 5, 2013

Last Update Submit

April 13, 2021

Conditions

Stroke

Keywords

StrokeTactileSensibilityStimulationExtremitiesArmLeg

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Disk-Criminator

    Change from 3 days after the patient has been hospitalized to 3 months

  • NIH Stroke Scale (NIHSS)

    Change from Baseline to 3 months

Study Arms (2)

Specific treatment + std stroke care

EXPERIMENTAL

Specific treatment in addition to standard stroke care

Other: Specific treatment in addition to standard stroke care

Std stroke care

NO INTERVENTION

Patients receive only standard stroke treatment and no specific treatment.

Interventions

Specific treatment in addition to standard stroke careOTHER

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.

Also known as: Icestimulation, Firm pressure, Brushing with soft brush, Rolling with spiked ball
Specific treatment + std stroke care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with impaired tactile sensitivity after stroke Kongsberg hospital to undergo rehabilitation course.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vestre Viken Health, clinic Kongsberg Hostpital

Kongsberg, Buskerud, 3612, Norway

Location

MeSH Terms

Conditions

Stroke

Interventions

Toothbrushing

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Oral HygienePreventive DentistryDentistry

Study Officials

  • Bjørn A Graff, PhD

    Vestre Viken Hospital Trust

    STUDY DIRECTOR

  • Bente Kristensen, BSc

    Vestre Viken Hospital Trust

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2013

First Posted

March 13, 2013

Study Start

March 1, 2013

Primary Completion

April 1, 2014

Study Completion

June 1, 2014

Last Updated

April 19, 2021

Record last verified: 2021-04

Locations

NO(1)