title: Electrical somatosensory stimulation followed by motor training of the paretic upper limb in acute stroke: study protocol for a randomized controlled trial.
abstract: Upper limb paresis is one of the most frequent and persistent impairments following stroke. Only 12-34% of stroke patients achieve full recovery of upper limb functioning, which seems to be required to habitually use the affected arm in daily tasks. Although the recovery of upper limb functioning is most pronounced during the first 4 weeks post stroke, there are few studies investigating the effect of rehabilitation during this critical time window. The purpose of this trial is to determine the effect of electrical somatosensory stimulation (ESS) initiated in the acute stroke phase on the recovery of upper limb functioning in a nonselected sample of stroke patients.
  
  
  
  A sample of 102 patients with upper limb paresis of varying degrees of severity is assigned to either the intervention or the control group using stratified random sampling. The intervention group receives ESS plus usual rehabilitation and the control group receives sham ESS plus usual rehabilitation. The intervention is applied as 1 h of ESS/sham ESS daily, followed by motor training of the affected upper limb. The ESS/sham ESS treatment is initiated within 7 days from stroke onset and it is delivered during hospitalization, but no longer than 4 weeks post stroke. The primary outcome is hand dexterity assessed by the Box and Block Test; secondary outcomes are the Fugl-Meyer Assessment, hand grip strength, pinch strength, perceptual threshold of touch, degree of pain, and modified Rankin Scale score. Outcome measurements are conducted at baseline, post intervention and at 6-month follow-up.
  
  
  
  Because of the wide inclusion criteria, we believe that the results can be generalized to the larger population of patients with a first-ever stroke who present with an upper limb paresis of varying severity. On the other hand, the sample size (n = 102) may preclude subgroup analyses in such a heterogeneous sample. The sham ESS treatment totals a mere 2% of the active ESS treatment delivered to the intervention group per ESS session, and we consider that this dose is too small to induce a treatment effect.
  
  
  
  ClinicalTrials.gov, NCT02250365 . Registered on 18 September 2014.
authors.affiliation: Department of Physical and Occupational Therapy, Bispebjerg Hospital, Bispebjerg Bakke 23, bldg. 10, 2400, Copenhagen, Denmark. emma.ghaziani@regionh.dk.|Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. emma.ghaziani@regionh.dk.
authors.forename: Emma
authors.identifier: 0000-0003-1681-4562
authors.initials: E
authors.lastname: Ghaziani
authors.affiliation: Department of Physical and Occupational Therapy, Bispebjerg Hospital, Bispebjerg Bakke 23, bldg. 10, 2400, Copenhagen, Denmark.|Institute of Sports Medicine, Department of Orthopaedic Surgery M, Bispebjerg Hospital, Copenhagen, Denmark.|Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Christian
authors.initials: C
authors.lastname: Couppé
authors.affiliation: Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Cecilie
authors.initials: C
authors.lastname: Henkel
authors.affiliation: The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Volkert
authors.initials: V
authors.lastname: Siersma
authors.affiliation: Department of Neurology, Bispebjerg Hospital, Copenhagen, Denmark.
authors.forename: Mette
authors.initials: M
authors.lastname: Søndergaard
authors.affiliation: Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.|Department of Neurology, Bispebjerg Hospital, Copenhagen, Denmark.
authors.forename: Hanne
authors.initials: H
authors.lastname: Christensen
authors.affiliation: Department of Physical and Occupational Therapy, Bispebjerg Hospital, Bispebjerg Bakke 23, bldg. 10, 2400, Copenhagen, Denmark.|Institute of Sports Medicine, Department of Orthopaedic Surgery M, Bispebjerg Hospital, Copenhagen, Denmark.|Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
authors.forename: S Peter
authors.initials: SP
authors.lastname: Magnusson
mesh_terms: D002985:Clinical Protocols; D004599:Electric Stimulation Therapy / Q000379:methods*; D018737:Hand Strength; D006801:Humans; D017063:Outcome Assessment, Health Care; D010291:Paresis / Q000534:rehabilitation*; D018401:Sample Size; D016037:Single-Blind Method; D020521:Stroke / Q000503:physiopathology*; D000071939:Stroke Rehabilitation / Q000379:methods*; D034941:Upper Extremity / Q000503:physiopathology*
keywords: Acute stroke; Electrical stimulation; Longitudinal studies; Recovery of function; Rehabilitation; Upper extremity