Table 1.

Clinical trials using BCI and/or robotic-assisted rehabilitation in stroke identified from clinicaltrials.gov

Clinicaltrials.gov identifier	Intervention (s)	Duration of training	Participants enrolled (actual/ estimated)	Primary outcome measure (s)	Secondary outcome measure (s)	Has results posted (Y/N)
NCT00955838	BCI-MIT-manus versus MIT-manus	12 sessions— frequency unknown	40	Motricity score; FMA-UE; MAS	Functional assessments; neuroradiological parameters	No
NCT01287975	Standard OT versus BCI—haptic knob versus haptic knob	Three times per week/6 weeks	60	ARAT; FMA-UE	Frenchay arm test; grip strength; modified ashworth scale; FIM; pain score	No
NCT01897025	Real tDCS + MI-BCI versus sham tDCS + MI-BCI (MIT manus)	Ten sessions— frequency unknown	32	FMA-UE	RMT of affected Ml; grip strength; box & block test; MRI parameters	No
NCT00746525	BCI + FES training for elbow, wrist and finger coordination	Five times per week/12 weeks	66	FMA-UE; AMAT; EEG; fMRI	Strength testing; robotics testing; Wisconsin card sort; stroop;	No
NCT01948739	BCI-MAHI-Exo II robotic- training	Three times per week/4 weeks	30	FMA-UE motor score	JTHFT; ARAT; brain volume of activation; pain and fatigue scores; grip and pinch strength; robotic motor measures of trajectory error and smoothness	No
NCT01724164	Robotic arm trainer—bimanu-track.	Five times per week/4 weeks	100	FMA	N/A	No
	Robotic therapy versus mirror therapy versus conventional therapy versus robotic therapy + FES versus Mirror therapy + FES
NCT01552733	Robotic training (MIT inmotion robot) versus standard of care	12 sessions, frequency unknown	80	FMA; feasibility (defined as no. of individuals completing 12 sessions)	FMA; modified rankin score; barthel Index; stroke impact scale; NIHSS; ARAT	No
NCT01689883	Armeo spring UL robotic training + stochastic resonance stimulation versus Armeo spring UL robotic training + sham stimulation	Frequency/duration unknown	20	Grip strength; box & block test	Modified ashworth scale; MAL; JTHFT; FMA-UE	No
*NCT00075283	Gait training with Lokomat versus conventional gait training	Three times per week/8–10 weeks (24 sessions in total)	50	N/A	N/A	No
NCT00372411	MIT-manus robotic therapy versus intense comparison therapy versus usual care	36 treatment sessions in total over 12 weeks (four blocks of nine sessions each for robotic therapy)	127	FMA-UE	Stroke Impact Scale; Wolf Motor function test; NRS for pain; Modified Ashworth scale	Yes
NCT01945515	Robotic gait training (Walkbot exoskeleton) + anodal tDCS versus Robotic gait training + sham tDCS	Five times per week/2 weeks	34	Functional ambulatory category score	10-m walk test; 6-min walk test; modified rankin scale; FMA-LE; motor evoked potential	No
**NCT01726998	Robot-assisted gait training with Lokomat (in addition to conventional PT) versus conventional gait training	Daily for 4 weeks	36	Change in functional ambulatory category score	N/A	No
NCT00975156	Lokomat gait training versus conventional PT	Five times per week/8 weeks (total 40 sessions)	21	10-m walk test	6-min walking distance	Yes
***NCT01994395	Stride management assist (Honda’s walking assist device) versus Impairment based physical therapy	18 sessions over approximately 8 weeks	58	10-m walk test (change from baseline)	ABC scale; NPRS; SS-QOL; mFES; PHQ- 9; TMS; 6-min walk test (change from baseline); berg balance scale	No
NCT02114450	Rbot-assisted training with H2 powered lower limb exoskeleton versus Supervised motor practice	12 sessions over approximately 4 weeks	60	Change from baseline in: FMA-LE; FGA; lower limb kinematics during walking; cortical dynamics measured by EEG	Change from baseline in: Robotic measure of performance; berg balance scale score; distance walked in 6-min walk test; timed up & go test	No

^*This study record is old and has not been updated on ClinicalTrials.gov, but appears to be published in [50]

^**No secondary outcome measures were indicated in the database fields, but free text in the description suggests that Motricity Index, Modified Barthel Index, FMA-LE and MRC scores for LE are likely secondary outcomes

^***This study did not appear in the search results for the terms specified, but is included as it pertains to the Walking Assist Device

FMA—fugl meyer assessment, UE—upper extremity, LE—lower extremity, MAL—motor activity log, MAS—motor assessment scale, ARAT—action research arm test, FIM—functional independence measure, JTHFT—jebsen taylor hand function test, NIHSS—NIH stroke scale, RMT—resting motor threshold, Ml—primary motor cortex, PT—physical therapy, NRS—numeric rating scale, AMAT—arm motor ability test, ABC—activities specific balance confidence, NPRS—numeric pain rating scale, SS-QOL—stroke-specific quality of life, mFES—modified falls efficacy scale, PHQ-9—patient health questionnaire-9, TMS—transcranial magnetic stimulation to measure corticomotor drive, FGA—Functional Gait assessment