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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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