An interventional study of WA group and Control in Stroke, sponsored by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan. Completed at 31 sites in Japan. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-06-17.
Sponsored by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan · Not applicable, Interventional, and Treatment
Among the sequelae of stroke, gait disorder is directly linked to the degree of autonomy in the daily life of patients. It is considered significant effects on their Quality of Life(QOL).
Further methods of rehabilitation are required for convalescent patients to recover their function soon and better, due to a multitudes of recovery patient with troubles such as gait problem.
This trial is studying to investigate the effects of gait training with a functional electrical stimulation (FES) 'WalkAide[R](WA)' to improve the lower-limb function and ambulation in convalescent stroke patients.
This study is targeting convalescent patients within 6 months after the onset of initial stroke (cerebral infarction or cerebral hemorrhage) and also observing the foot drop during walking.
Some study for the patients after the onset of stroke (over several months) are reported that a case of the efficacy by the treatment using the FES, and another case of using FES indicated the equal efficacy and the higher QOL compared to using ankle-foot orthosis(AFO).
However, these are clinical research results overseas and there are not so many studies targeting only for convalescent stroke patients.
FES which recover the lost function by paralysis using electrical stimulation is recommended as convalescent rehabilitation by Japanese Guidelines for the Management of Stroke 2015 etc..
The purpose of FES treatment is the electrical stimulation to peroneal nerve of patients with foot drop and equinus foot due to central nervous system damage and the objective efficacy is following:
7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's enrollment of 202 is above the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan is the lead sponsor of 55 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: WA group
Other: Control
Conventional rehabilitation therapy and gait training with WAIntervention with WA is scheduled 40min/day, five times a week, for 8 weeks.
Conventional rehabilitation therapy and gait training without WA.
maximum walking distance of 6 Minute Walk Test (bare feet)
Measuring maximum walking distance of 6 Minute Walk Test at baseline and after 8-weeks intervention. Calculating difference of those measured values. Targeting for all patients.
Time frame: 8weeks
maximum walking distance of 6 Minute Walk Test (with WA)
Measuring maximum walking distance of 6 Minute Walk Test at baseline and after 8-weeks intervention. Calculating difference of those measured values. Targeting only for WA group.
Time frame: 8weeks
maximum walking distance of 6 Minute Walk Test (with AFO)
Measuring maximum walking distance of 6 Minute Walk Test at baseline and after 8-weeks intervention. Calculating difference of those measured values. Targeting only for patients using AFO before starting this study.
Time frame: 8weeks
walking speed of 10 Meter Walk Test (bare feet)
Measuring maximum walking speed of 10 Meter Walk Test at baseline and after 8-weeks intervention. Calculating difference of those measured values. Targeting for all patients.
Time frame: 8weeks
walking speed of 10 Meter Walk Test (with WA)
Measuring maximum walking speed of 10 Meter Walk Test at baseline and after 8-weeks intervention. Calculating difference of those measured values. Targeting only for WA group.
Time frame: 8weeks
walking speed of 10 Meter Walk Test (with AFO)
Measuring maximum walking speed of 10 Meter Walk Test at baseline and after 8-weeks intervention. Calculating difference of those measured values. Targeting only for patients using AFO before starting this study.
Time frame: 8weeks
Fugl-Meyer assessment (FMA)
Calculating difference of the total score of lower extremity subscale of the Fugl-Meyer Assessment (perfect score: 34 points) at baseline and after 8-weeks intervention.
Time frame: 8weeks
modified Ashworth scale (MAS)
Calculating difference of the muscle tone six levels ( 0 , 1 , 1+ , 2 , 3 , 4 ) at baseline and after 8-weeks intervention.
Time frame: 8weeks
range of motion
Calculating difference of the angle of the ankle succumbed back (5 ° increments) at baseline and after 8-weeks intervention.
Time frame: 8weeks
Timed up and go test (bere feet)
Measuring the time that patients take to rise from a chair, walk three metres, turn around, walk back to the chair, and sit down . Calculating difference of those measured values between at baseline and after 8-weeks intervention. Targeting for all patients.
Time frame: 8weeks
Timed up and go test (with AFO)
Measuring the time that patients take to rise from a chair, walk three metres, turn around, walk back to the chair, and sit down . Calculating difference of those measured values between at baseline and after 8-weeks intervention. Targeting only for patients using AFO before starting this study.
Time frame: 8weeks
Timed up and go test (with WA)
Measuring the time that patients take to rise from a chair, walk three metres, turn around, walk back to the chair, and sit down . Calculating difference of those measured values between at baseline and after 8-weeks intervention. Targeting only for WA group.
Time frame: 8weeks
Stroke Impact Scale (SIS)
An evaluation of summation score of the total score and physical domain (sixth domain) score. Calculating difference of those measured values between at baseline and after 8-weeks intervention.
Time frame: 8weeks
Patient reported outcome measure (PRO)
Evaluation gait analysis using visual analogue scale(VAS scale) by Patient's own. Calculating the difference of these VAS scale between at baseline and after 8-weeks intervention.
Time frame: 8weeks
gait analysis by medical staff
Evaluation using total score of gait analysis by medical staff (-48\~48).Calculating difference of these score between at baseline and after 8-weeks intervention.
Time frame: 8weeks
Adverse event assessment
A frequency counting of the adverse events. LLT code will be assigned to the reported adverse event using the MedDRA dictionary. The origin date of the term until adverse events define the start date of the treatment program(0 week). Also doing a frequency counting of adverse events observed during the the WA trial operation period, but not included in the safety evaluation of the treatment program.
Time frame: 8weeks
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan