Effectiveness of Multichannel Functional Electrical Stimulation

Status unconfirmed · Not applicable

Conditions studied: Stroke, Hemiparesis

In brief

The purpose of this pilot study is to determine whether two weeks of multi-channel FES along with task-specific training will improve UE function when compared to traditional rehabilitation or usual care. The secondary purpose of this study is to find whether two weeks of multi-channel FES along with task-specific training will improve shoulder range of motion, grip strength, and patient reported function when compared to traditional rehabilitation or usual care in patients with unilateral stroke resulting in hemiplegia.The following null hypotheses are established for this study: 1. There will be no difference in UE function when using multi-channel FES along with task-specific training compared to traditional rehabilitation or usual care in patients with first time stroke and hemiplegia during in patient stroke rehabilitation. 2. There will be no difference in shoulder range of motion and grip strength when using multi-channel FES along with task-specific training compared to traditional rehabilitation or usual care in patients with first time stroke and hemiplegia during in patient stroke rehabilitation. 3. There will be no difference in self-reported upper extremity function when using multi-channel FES along with task-specific training compared to traditional rehabilitation or usual care in patients with first time stroke and hemiplegia during in patient stroke rehabilitation.The research design for this experimental study will be a randomized controlled trial. The manipulated independent variable in this study will be 1) FES using Xcite with traditional therapy and 2) traditional therapy. The dependent variables in this study are the following: Upper extremity function measured by The Action Research Arm Test, The Box and Block Test, and The Nine-Hole Peg Test; Grip strength measured using a dynamometer; Range of motion at the shoulder measured using a standard goniometer; and Participants' perception of improvement in function measured by a modified Patient-Specific Functional Scale.

Key facts

Study ID: NCT04876703
Run by: Baylor Research Institute
People needed: 40
Starts: 2021-06-17
Expected to finish: 2023-06-15
Last updated by the study team: 2022-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

first-time unilateral stroke survivors with less than 3 months since onset with upper extremity hemiplegia/hemiparesis over the age of 18

You may not qualify if…

Participants who have comorbidities impacting motor function (Parkinson's, congenital disorders) or contraindications for NMES (seizure disorders, uncontrolled cardiac conditions, cancer, pacemaker, significant sensory deficits, contractures, pregnancy, unhealed fractures, or a cerebellar stroke), and who are unable to follow two-step commands

Where it is running

Baylor Scott and White Institute for Rehabilitation — Frisco, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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