A pilot study of randomized clinical controlled trial of gait training in subacute stroke patients with partial body-weight support electromechanical gait trainer and functional electrical stimulation: six-month follow-up.
OBJECTIVE
This study aimed to assess the effectiveness of gait training using an electromechanical gait trainer with or without functional electrical stimulation for people with subacute stroke.


METHODS
This was a nonblinded randomized controlled trial with a 6-month follow-up. Fifty-four subjects were recruited within 6 weeks after stroke onset and were randomly assigned to 1 of 3 gait intervention groups: conventional overground gait training treatment (CT, n=21), electromechanical gait trainer (GT, n=17) and, electromechanical gait trainer with functional electrical stimulation (GT-FES, n=16). All subjects were to undergo an assigned intervention program comprising a 20-minute session every weekday for 4 weeks. The outcome measures were Functional Independence Measure, Barthel Index, Motricity Index leg subscale, Elderly Mobility Scale (EMS), Berg Balance Scale, Functional Ambulatory Category (FAC), and 5-meter walking speed test. Assessments were made at baseline, at the end of the 4-week intervention program, and 6 months after the program ended.


RESULTS
By intention-to-treat and multivariate analysis, statistically significant differences showed up in EMS (Wilks' lambda=0.743, P=0.005), FAC (Wilks' lambda=0.744, P=0.005) and gait speed (Wilks' lambda=0.658, P<0.0001). Post hoc analysis (univariate 2-way ANCOVA) revealed that the GT and GT-FES groups showed significantly better improvement in comparison with the CT group at the end of the 4 weeks of training and in the 6-month follow-up.


CONCLUSIONS
For the early stage after stroke, this study indicated a higher effectiveness in poststroke gait training that used an electromechanical gait trainer compared with conventional overground gait training. The training effect was sustained through to the 6-month follow-up after the intervention.
Ng
Maple F W
MF
Department of Health Technology and Informatics, The Hong Kong Polytechnic University, Hong Kong, China.
Tong
Raymond K Y
RK
Li
Leonard S W
LS
D000368:Aged; D000369:Aged, 80 and over; D001696:Biomechanical Phenomena; D001835:Body Weight / Q000502:physiology*; D004599:Electric Stimulation Therapy / Q000295:instrumentation / Q000379:methods*; D005081:Exercise Therapy / Q000295:instrumentation / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D020233:Gait Disorders, Neurologic / Q000209:etiology* / Q000503:physiopathology / Q000534:rehabilitation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D051346:Mobility Limitation; D015999:Multivariate Analysis; D026741:Physical Therapy Modalities; D010865:Pilot Projects; D020521:Stroke / Q000150:complications* / Q000503:physiopathology; D000071939:Stroke Rehabilitation; D016896:Treatment Outcome