CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 67 enrolled
Drug / intervention
Electrical Stimulatordevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01688856
NCT01688856N/ACompleted

Optimizing Contralaterally Controlled FES for Acute Upper Limb Hemiplegia

MetroHealth Medical Center·interventional·Posted Sep 20, 2012·Updated Jan 9, 2020

In Brief

A clinical study evaluating Electrical Stimulator for Stroke and 2 related conditions. Completed, enrolled 67 participants across 1 site.

Detailed Summary

Impaired arm and hand function is one of the most disabling and most common consequences of stroke. The Investigators have developed Contralaterally Controlled Functional Electrical Stimulation (CCFES), an innovative neuromuscular electrical stimulation (NMES) treatment for improving the recovery of hand function after stroke. The purpose of this study is to maximize the treatment effect of CCFES by adding stimulated elbow extension. The specific aims and hypotheses are as follows: AIM 1: Estimate the effect of Arm+Hand CCFES on upper limb motor impairment and activity limitation. Hypothesis 1: Stroke survivors treated with Arm+Hand CCFES have better outcomes on upper limb impairment and activity limitation measures than those treated with dose-matched Arm+Hand Cyclic NMES. AIM 2: Estimate the effect of adding stimulated elbow extension to Hand CCFES. Hypothesis 2: Stroke survivors treated with Arm+Hand CCFES will have greater reductions in upper limb impairment and activity limitation than those treated with Hand CCFES. AIM 3: Describe the relationship between treatment effect and time elapsed between stroke onset and start of treatment. Hypothesis 3: Patients who start Arm+Hand CCFES sooner after their stroke achieve better outcomes.

Study Details

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 20, 2012
Enrollment StartJan 1, 2013
Primary CompletionAug 1, 2018
Study CompletionAug 31, 2018
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 13.8 years ago

Interventions

Electrical Stimulatordevice

The 12-week treatment period consists of two components: 1. Therapist-guided task practice performed 70 minutes twice a week in the research laboratory. If Arm+Hand CCFES or Hand CCFES, the stimulator is used during task practice. 2. Self-administered muscle stimulation exercise performed 10 sessions per week at home using the device. If Arm+Hand CCFES or Hand CCFES, each session is 46 minutes. If Arm+Hand Cyclic NMES, each session is 60 minutes.