Recruiting

Multichannel FES

Sponsor:

Baylor Research Institute

Code:

NCT04876703

Conditions

Stroke

Hemiparesis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Multichannel Functional electrical stimulation

Standard motor training

Study Details

Brief 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

Study ID

NCT04876703

Start date

Jun 17, 2021

Status verified date

Mar, 2022

Completion date

Jun 15, 2023

Anticipated

Primary completion date

Dec 15, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Excite group (Group A)

The experimental group (Group A) will receive standard motor retraining of the affected upper extremity in addition to functional electrical stimulation provided by means of Xcite system 4 days per week for 30 minutes for two weeks.

active comparator: Standard motor training group (Group B)

The control group (Group B) will receive standard motor retraining of the upper extremity.

Interventions

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.

Standard motor training

Standard motor training is the conventional rehabilitation treatment

Primary outcome measure

  • Change in Action Research Arm Test (ARAT) [ Time Frame: Baseline measurement will be assessed within 24 hours before starting the intervention protocol and follow up measurements will be taken within a week after completion of the intervention. ]
  • Change in The Box and Block Test (BBT) [ Time Frame: Baseline measurement will be assessed within 24 hours before starting the intervention protocol and follow up measurements will be taken within a week after completion of the intervention. ]
  • Change in The Nine-Hole Peg Test (NHPT) [ Time Frame: Baseline measurement will be assessed within 24 hours before starting the intervention protocol and follow up measurements will be taken within a week after completion of the intervention. ]

Central Contacts and Locations

Central contacts

Caitlin Boyd

469-888-5170cboyd@bswrehab.com

Sofiya Mistry

469-888-5170SoMistry@bswrehab.com

Locations

Baylor Scott and White Institute for Rehabilitation

Recruiting

Frisco, Texas, United States, 75034

Contacts

Caitlin Boyd, MOT

469-888-5170CaiBoyd@BSWRehab.com

Sofiya Mistry, DPT

469-888-5170SoMistry@BSWRehab.com

More Information

Sponsor

Baylor Research Institute

Last update posted

Mar 10, 2022

Last verified

Mar, 2022

Keywords

  • Upper extremity function
  • Functional electrical stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baylor Research Institute on 2022-03-10.