RALLY study

Not Applicable

• Conditions: stroke

• Registration Number: JPRN-jRCTs032180314
• Lead Sponsor: Matsumoto Shuji

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-15
• Study Completion: 2020-03-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 203

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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