Status:

COMPLETED

Electrical Stimulation of the Paretic Upper Limb in the Early Stroke Phase

Lead Sponsor:

University of Copenhagen

Collaborating Sponsors:

Bispebjerg Hospital

Region Capital Denmark

Conditions:

Stroke, Acute

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

This study evaluates the effect of electrical somatosensory stimulation (ESS) on the restoration of upper limb functioning in acute stroke patients. The effect will be measured at the end of the inter...

Detailed Description

1. Introduction Globally, stroke is ranked as the second leading cause of death and the third largest cause of disease burden. Stroke is associated with tremendous physical, psychological and econ...

Eligibility Criteria

Inclusion

  • admission at the rehabilitation stroke unit of Bispebjerg Hospital, Copenhagen,
  • diagnosis of acute stroke (ICD 10 code: 163.9, 161.9),
  • residence in the hospitals' catchment area,
  • age \> 18 years,
  • modified Rankin Scale score \< 5,
  • ESS can be initiated within 7 days post-stroke,
  • a subscore \< 66 on section A-D of Fugl-Meyer Assessment Upper Extremity,

Exclusion

  • presence of cognitive dysfunctions or poor communication skills in Danish that limit the ability of providing informed consent,
  • have participated in other biomedical, intervention studies within the last 3 months,
  • contraindication to ESS (e.g. pacemaker, significant skin impairment on the paretic arm),
  • incomplete recovery of the affected upper limb after previous stroke,
  • patients who - because of placement in an institution, incarceration pursuant to the Psychiatric Act or due to circumstances of employment - are particularly exposed to pressure regarding participation in the project.

Key Trial Info

Start Date :

October 13 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 10 2017

Estimated Enrollment :

102 Patients enrolled

Trial Details

Trial ID

NCT02250365

Start Date

October 13 2014

End Date

August 10 2017

Last Update

August 18 2017

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Bispebjerg Hospital

Copenhagen, Region Sjælland, Denmark, 2400

2

Neurological Rehabilitation Centre Copenhagen & other rehabilitation and health care institutions

Copenhagen, Region Sjælland, Denmark, 2400

3

Lioba & Rehabilitation Centre Valby & Heath Centre Stockflethsvej & other rehabilitation and health care institutions

Frederiksberg, Region Sjælland, Denmark, 2000