Electrical somatosensory stimulation followed by motor training of the paretic upper limb in acute stroke: study protocol for a randomized controlled trial

Table 1 Time schedule of enrollment, intervention, assessments and responsible trial personnel

Trial procedure	Time points during the course of the trial					Responsible personnel	Blinded to group allocation?
Trial procedure	Stroke onset – 7 days post stroke	ESS treatment	Post- intervention	Hospital discharge	6-month follow-up	Responsible personnel	Blinded to group allocation?
Assess eligibility	X					EG	Not applicable
Present trial information for potential participants	X					EG/ESS personnel	Not applicable
Collect informed consent	X					EG	Not applicable
Group allocation	X					Administrative personnel/SPM	No/no
Assess outcome	X		X		X	EG	Yes
Collect sociodemographic data	X			X	X	EG	Yes
Collect medical data	X			X	X	MS/EG/ESS personnel	Yes/yes/no
Collect data on prestroke nutritional habits and physical activity	X					EG/ESS personnel	Yes/no
Collect data on upper limb training and usual rehabilitation		X				OTs or PTs at the stroke unit and in the community	Yes
Collect data on ESS treatment, including adverse events		X				ESS personnel	No

EG Emma Ghaziani, ESS electrical somatosensory stimulation, MS Mette Søndergaard, OT occupational therapist, PT physiotherapist, SPM S. Peter Magnusson

ISSN: 1745-6215