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The theRapeutic effects of peroneal nerve functionAl electrical stimuLation for Lower extremitY in patients with sub-acute post-stroke hemiplegia (RALLY)
A randomized controlled study (RALLY study)

RALLY study (RALLY study)

203

Of the 92 patients in the WalkAide (WA) group, 70 (76.1%) were male and 22 (23.9%) were female. Of the 92 patients in the control group, 68 (73.9%) were male and 24 (26.1%) female.

Subject enrollment was completed in 28 months. A total of 203 patients were randomized to the either WA group (102 patients) or control group (101 patients). Primary analysis population consisted of 92 patients in the WA group and 92 patients in the control group.

Adverse events were observed in 7 patients (7.4%) in the WA group and 2 patients (2.1%) in the control group, but no adverse events associated with the devices were observed. One serious adverse event (femoral fracture) was observed in the WA group (1.1%).

[Primary endpoint] There was no statistically significant difference in the primary endpoint (the change of 6-minute walk test distance performed with barefoot) between groups (p=0.26). [Secondary endpoints] [Primary endpoint] There was no statistically significant difference in the primary endpoint (the change of 6-minute walk test distance performed with barefoot) between groups (p=0.26). [Secondary endpoints] 1. The maximum walking distance in the 6-minute walk test performed with WA-assisted was significantly different before and after treatment period (p<0.0001). 2. There was no statistically significant difference between groups in the change of the 6-minute walk test distance performed with AFO-assisted (p=0.39). 3. There was no significant difference between groups in the change of the 10 meter walk test speed performed with barefoot (p=0.16). 4. The walking time in the 10 meter walk test performed with WA-assisted was significantly different before and after treatment (p<0.0001). 5. There was no significant difference between groups in the change of the 10 meter walk test speed performed with AFO-assisted (p=0.86). 6. There was no significant difference between groups in the change of the total Fugl-Meyer assessment score (p =0.34). 7. There was no significant difference between groups in the change of the modified Ashworth scale scores (knee extended p=0.76, knee flexed p=0.15). 8. The change in the automatic dorsiflexion angle before and after the treatment was significantly different in the WA group as compared to the control group (p=0.001). There was no significant difference between the groups in the change of the passive dorsiflexion angle (knee flexed p = 0.41, knee extended p = 0.21). 9. There was no significant difference between groups in the change of timed up and go (TUG) test speed performed with barefoot (comfortable p=0.58, maximum p=0.49). 10. The walking time in the TUG test performed with WA-assisted was significantly different before and after treatment (p <0.0001). 11. There was no significant difference between groups in the change of timed up and go test speed performed with AFO assisted (comfortable p=0.78, maximum p=0.49). 12. There was no significant difference between groups in the change of overall stroke impacts scale (p=0.41). 13. The changes in the question 2(spasticity while walking bare-footed) and question 3(stability in bare-footed walking) of patient reported outcome were significantly improved in the WA group as compared to the control group (question2 p=0.005, question3 p=0.02). 14. The change in the gait condition scores evaluated by therapist was significantly improved in the WA group as compared to the control group (p=0.03).

The findings of the current study demonstrated the feasibility of applying WA for dropped foot during the convalescent phase of recovery after stroke.

Oct. 31, 2021

No

No plan

https://jrct.mhlw.go.jp/latest-detail/jRCTs032180314

Matsumoto Shuji

Nippon Medical School Chiba Hokusoh Hospital

1715 Kamakari,Inzai-shi,Chiba 270-1694, Japan

m-shuji@nms.ac.jp

Matsumoto Shuji

Nippon Medical School Chiba Hokusoh Hospital

1715 Kamakari,Inzai-shi,Chiba 270-1694, Japan

+81-476-99-1111

m-shuji@nms.ac.jp

Complete

May. 01, 2016

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1) Patients who agree to participate in this study and provide their informed consent
2) Patients from 20 to 85 years old at the time of consent
3) Patients of convalescent stoke (within 6 months of onset)
4) Patients with a first episode of stroke, which type limited intracranial hemorrhage or ischemic stroke (excluding subarachnoid hemorrhage)
5) Patients inpatients for the rehabilitation therapy
6) Patients diagnosed 3 or 4 on Functional Ambulation Classification (FAC)
7) Patients stable general condition (blood pressure, pulse, blood glucose level etc.)
8) Patients with drop foot in walking

1) Patients due to severe heart disease
2) Patients with previous gait disability, such as neurological disease
3) Patients with previous orthopedic disease, such as knee osteoarthritis
4) Patients with severe hepatic or renal dysfunction
5) Patients with severe sensory disturbance or severe ataxia or severe higher brain dysfunction
6) Patients correspond to contraindicated for the electrical stimulation (e.g. patients with a medical implant or implantable medical electrical equipment such as a cardiac pacemaker)
7) Patients with severe skin disease
8) Patients with any dose adjustment of antispasticity drugs (tizanidine hydrochloride, eperisone hydrochloride, baclofen, etc.) within 1month
9) Patients whose impairment severities changed during the study period
10) Patients taking the botulinum toxin formulation injection or the nerve block injection with phenol within 6months
11) Patients with any lower limb treatment using FES or the robot suit within 1month
12) Patients diagnosed not to use during the WA trial operation period
13) Patients who do not complete the WA trial operation for 7 days
14) Patients joining any other clinical trials or studies with intervention

Both

stroke

WA group : Gait training with functional electrical stimulation (FES) + conventional rehabilitation therapy. Intervention with FES is scheduled 40min/day, five times a week, for 8 weeks.
Control group : Gait training without functional electrical stimulation (FES) + conventional rehabilitation therapy.

stroke

Rehabilitation, functional electrical stimulation (FES), WalkAide (WA)

maximum walking distance of 6 Minute Walk Test (bare feet)

1)maximum walking distance of 6 Minute Walk Test (with WA)
2)maximum walking distance of 6 Minute Walk Test (with AFO)
3)walking speed of 10 Meter Walk Test (bare feet)
4)walking speed of 10 Meter Walk Test (with WA)
5)walking speed of 10 Meter Walk Test (with AFO)
6)Fugl-Meyer assessment (FMA)
7)modified Ashworth scale (MAS)
8)range of motion
9)Timed up and go test (bere feet)
10)Timed up and go test (with AFO)
11)Timed up and go test (with WA)
12)Stroke Impact Scale (SIS)
13)Patient reported outcome measure (PRO)
14)gait analysis by medical staff
15)Adverse event assessment

+81-3-5802-8202

Jan. 31, 2019

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