jRCTs032180314CompletedNot Applicable
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)
Not provided0 sites200 target enrollmentStarted: August 30, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 200
- Primary Endpoint
- -
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized Controlled Trial
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Open(masking Not Used)
Eligibility Criteria
- Ages
- 20age old over to 85age old under (—)
- Sex
- All
Inclusion Criteria
- •Patients who agree to participate in this study and provide their informed consent
- •Patients from 20 to 85 years old at the time of consent
- •Patients of convalescent stoke (within 6 months of onset)
- •Patients with a first episode of stroke, which type limited intracranial hemorrhage or ischemic stroke (excluding subarachnoid hemorrhage)
- •Patients inpatients for the rehabilitation therapy
- •Patients diagnosed 3 or 4 on Functional Ambulation Classification (FAC)
- •Patients stable general condition (blood pressure, pulse, blood glucose level etc.)
- •Patients with drop foot in walking
Exclusion Criteria
- •Patients due to severe heart disease
- •Patients with previous gait disability, such as neurological disease
- •Patients with previous orthopedic disease, such as knee osteoarthritis
- •Patients with severe hepatic or renal dysfunction
- •Patients with severe sensory disturbance or severe ataxia or severe higher brain dysfunction
- •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)
- •Patients with severe skin disease
- •Patients with any dose adjustment of antispasticity drugs (tizanidine hydrochloride, eperisone hydrochloride, baclofen, etc.) within 1month
- •Patients whose impairment severities changed during the study period
- •Patients taking the botulinum toxin formulation injection or the nerve block injection with phenol within 6months
- •Patients with any lower limb treatment using FES or the robot suit within 1month
- •Patients diagnosed not to use during the WA trial operation period
- •Patients who do not complete the WA trial operation for 7 days
- •Patients joining any other clinical trials or studies with intervention
Outcomes
Primary Outcomes
-
maximum walking distance of 6 Minute Walk Test (bare feet)
Secondary Outcomes
- Stroke Impact Scale (SIS)
- Patient reported outcome measure (PRO)
- gait analysis by medical staff
- Adverse event assessment
- maximum walking distance of 6 Minute Walk Test (with WA)
- maximum walking distance of 6 Minute Walk Test (with AFO)
- walking speed of 10 Meter Walk Test (bare feet)
- walking speed of 10 Meter Walk Test (with WA)
- walking speed of 10 Meter Walk Test (with AFO)
- Fugl-Meyer assessment (FMA)
- modified Ashworth scale (MAS)
- range of motion
- Timed up and go test (bare feet)
- Timed up and go test (with AFO)
- Timed up and go test (with WA)
Investigators
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