Effectiveness of Multichannel Functional Electrical Stimulation

Summary

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.

Conditions

• Stroke
• Hemiparesis

Interventions

DEVICE

Multichannel Functional electrical stimulation

The Xcite system is a battery-powered stimulator with up to 12 channels of cyclical stimulation. It is a task-specific modality to enhance mass practice during neurological re-education.

OTHER

Standard motor training

Standard motor training is the conventional rehabilitation treatment

Sponsors & Collaborators

• Baylor Research Institute

  lead OTHER

Principal Investigators

• Caitlin Boyd · Baylor Scott and White Institute for Rehabilitation

• Priya Karakkattil, PhD · University of St. Augustine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-17

Primary Completion

2022-12-15

Completion

2023-06-15

FDA Device

Yes

Countries

• United States

Study Locations