JPRN-jRCTs032180314
Completed
N/A
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
Matsumoto Shuji0 sites203 target enrollmentMarch 15, 2019
Conditionsstroke
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- stroke
- Sponsor
- Matsumoto Shuji
- Enrollment
- 203
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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