Clinical effects of peroneal nerve functional electrical stimulation (WalkAide[R]) for the lower extremities in chronic stroke patients with hemiplegia: A multicneter, prospective, randomized controlled trial - Clinical effects of peroneal nerve functional electrical stimulation (WalkAide[R]) for chronic stroke patients (PLEASURE trial)

Moji Medical Center, Kyusyu Rosai Hospital, Japan Labour Health Welfare Organization0 sites120 target enrollmentJanuary 15, 2016

Conditionsstroke

Overview

Phase: N/A
Intervention: Not specified
Conditions: stroke
Sponsor: Moji Medical Center, Kyusyu Rosai Hospital, Japan Labour Health Welfare Organization
Enrollment: 120
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 15, 2016

End Date

July 30, 2017

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Moji Medical Center, Kyusyu Rosai Hospital, Japan Labour Health Welfare Organization

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•1\)Patients whose ankle dorsiflexion is not induced by the WA due to peripheral neuropathy 2\)Patients who are contraindicated for the WA (e.g., patients with a metallic implant or implantable medical electrical equipment such as a cardiac pacemaker, and patients with a previous or suspected history of seizure) 3\)Patients who underwent Botox treatment in the lower extremities within 3 months of this study registry 4\)Patients who have nervous system (excluding stroke), cardio\-respiratory system, or musculoskeletal system disorders, which may affect gait and training 5\)Patients who had fallen down within a week prior to the registry and are regarded to be at a high risk of falling down by an attending physician 6\)Patients whose impairment severities changed between the prior and initial assessments \*:Definition of an alteration (1\)Brunnstorm stage for the lower extremity: Confirm whether the stages of the prior and initial assessments are the same value. If these stages are different, this is considered to be an alteration, and the patient with this alteration should be excluded from the study. (2\)Lower extremity subscale of the Fugl\-Meyer Assessment: Confirm whether the change in the score between the prior and initial assessments is 5 or less. If the change is 6 or more, then this is considered to be an alteration, and the patient with this alteration should be excluded from the study. (3\)Functional Ambulation Classification: Confirm whether the categories of the prior and initial assessments are the same value. If these categories are different, then this is considered to be an alteration, and the patient with this alteration should be excluded from the study. 7\) Patients who are regarded to be ineligible for this study by the principal investigator or co\-investigators