Effectiveness of Multichannel Functional Electrical Stimulation

NCT04876703 | Unknown DMC FDA Device

• 1 other identifier: 020-306
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 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. 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. 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

Keywords

Upper extremity function; Functional electrical stimulation

Outcome Measures

Primary Outcomes (3)

• Change in Action Research Arm Test (ARAT)

  The Action Research Arm Test is a 19-item measure with 4 sub-categories (grasp, grip, pinch, and gross arm movement) to assess upper limb functioning. The ARAT is scored on a 4-point original Scale (3-Performs test normally, 2- Completes test, but takes abnormally long or has great difficulty, 1- Performs test partially, 0- Can perform no part of test).

  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)

  The assessment measures number of blocks a patient can grasp and transfer over a partition in one minute. A score for BBT is calculated by counting the number of blocks that were transferred in one-minute trial.

  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)

  The test includes use of a stop watch to calculate the amount of time needed to place and remove 9 pegs in holes on a pegboard. A score is calculated for the NHPT by the time taken to complete the activity (in seconds).

  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.

Secondary Outcomes (3)

• Change in Grip strength

  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 Upper extremity range of motion

  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 modified Patient-Specific Functional Scale

  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.

Study Arms (2)

Excite group (Group A)

EXPERIMENTAL

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.

Device: Multichannel Functional electrical stimulation

Standard motor training group (Group B)

ACTIVE COMPARATOR

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

Other: Standard motor training

Interventions

Multichannel Functional electrical stimulation DEVICE

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.

Excite group (Group A)

Standard motor training OTHER

Standard motor training is the conventional rehabilitation treatment

Standard motor training group (Group B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Scott and White Institute for Rehabilitation

Frisco, Texas, 75034, United States

RECRUITING

Related Publications (16)

• Alon G, Levitt AF, McCarthy PA. Functional electrical stimulation enhancement of upper extremity functional recovery during stroke rehabilitation: a pilot study. Neurorehabil Neural Repair. 2007 May-Jun;21(3):207-15. doi: 10.1177/1545968306297871. Epub 2007 Mar 16.

  PMID: 17369518 BACKGROUND

• Bertrand AM, Mercier C, Bourbonnais D, Desrosiers J, Gravel D. Reliability of maximal static strength measurements of the arms in subjects with hemiparesis. Clin Rehabil. 2007 Mar;21(3):248-57. doi: 10.1177/0269215506070792.

  PMID: 17329282 BACKGROUND

• Boissy P, Bourbonnais D, Carlotti MM, Gravel D, Arsenault BA. Maximal grip force in chronic stroke subjects and its relationship to global upper extremity function. Clin Rehabil. 1999 Aug;13(4):354-62. doi: 10.1191/026921599676433080.

  PMID: 10460123 BACKGROUND

• Camicia M, Wang H, DiVita M, Mix J, Niewczyk P. Length of Stay at Inpatient Rehabilitation Facility and Stroke Patient Outcomes. Rehabil Nurs. 2016 Mar-Apr;41(2):78-90. doi: 10.1002/rnj.218. Epub 2015 May 22.

  PMID: 26009865 BACKGROUND

• Chen HM, Chen CC, Hsueh IP, Huang SL, Hsieh CL. Test-retest reproducibility and smallest real difference of 5 hand function tests in patients with stroke. Neurorehabil Neural Repair. 2009 Jun;23(5):435-40. doi: 10.1177/1545968308331146. Epub 2009 Mar 4.

  PMID: 19261767 BACKGROUND

• Gajdosik RL, Bohannon RW. Clinical measurement of range of motion. Review of goniometry emphasizing reliability and validity. Phys Ther. 1987 Dec;67(12):1867-72. doi: 10.1093/ptj/67.12.1867.

  PMID: 3685114 BACKGROUND

• Gharib NM, Aboumousa AM, Elowishy AA, Rezk-Allah SS, Yousef FS. Efficacy of electrical stimulation as an adjunct to repetitive task practice therapy on skilled hand performance in hemiparetic stroke patients: a randomized controlled trial. Clin Rehabil. 2015 Apr;29(4):355-64. doi: 10.1177/0269215514544131. Epub 2014 Aug 14.

  PMID: 25125441 BACKGROUND

• Hefford C, Abbott JH, Arnold R, Baxter GD. The patient-specific functional scale: validity, reliability, and responsiveness in patients with upper extremity musculoskeletal problems. J Orthop Sports Phys Ther. 2012 Feb;42(2):56-65. doi: 10.2519/jospt.2012.3953. Epub 2012 Feb 1.

  PMID: 22333510 BACKGROUND

• Kwakkel G, Kollen BJ, van der Grond J, Prevo AJ. Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke. Stroke. 2003 Sep;34(9):2181-6. doi: 10.1161/01.STR.0000087172.16305.CD. Epub 2003 Aug 7.

  PMID: 12907818 BACKGROUND

• Lin KC, Chuang LL, Wu CY, Hsieh YW, Chang WY. Responsiveness and validity of three dexterous function measures in stroke rehabilitation. J Rehabil Res Dev. 2010;47(6):563-71. doi: 10.1682/jrrd.2009.09.0155.

  PMID: 20848369 BACKGROUND

• Mayo NE, Wood-Dauphinee S, Ahmed S, Gordon C, Higgins J, McEwen S, Salbach N. Disablement following stroke. Disabil Rehabil. 1999 May-Jun;21(5-6):258-68. doi: 10.1080/096382899297684.

  PMID: 10381238 BACKGROUND

• Nakayama H, Jorgensen HS, Raaschou HO, Olsen TS. Recovery of upper extremity function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1994 Apr;75(4):394-8. doi: 10.1016/0003-9993(94)90161-9.

  PMID: 8172497 BACKGROUND

• Vafadar AK, Cote JN, Archambault PS. Effectiveness of functional electrical stimulation in improving clinical outcomes in the upper arm following stroke: a systematic review and meta-analysis. Biomed Res Int. 2015;2015:729768. doi: 10.1155/2015/729768. Epub 2015 Jan 22.

  PMID: 25685805 BACKGROUND

• Xcite. (n.d). Restorative Therapies. Retrieved June 18th, 2020, from https://restorative-therapies.com/ifes-systems/xcite/

  BACKGROUND

• Yang JD, Liao CD, Huang SW, Tam KW, Liou TH, Lee YH, Lin CY, Chen HC. Effectiveness of electrical stimulation therapy in improving arm function after stroke: a systematic review and a meta-analysis of randomised controlled trials. Clin Rehabil. 2019 Aug;33(8):1286-1297. doi: 10.1177/0269215519839165. Epub 2019 Apr 12.

  PMID: 30977379 BACKGROUND

• Yozbatiran N, Der-Yeghiaian L, Cramer SC. A standardized approach to performing the action research arm test. Neurorehabil Neural Repair. 2008 Jan-Feb;22(1):78-90. doi: 10.1177/1545968307305353. Epub 2007 Aug 17.

  PMID: 17704352 BACKGROUND

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Caitlin Boyd

  Baylor Scott and White Institute for Rehabilitation

  PRINCIPAL INVESTIGATOR

• Priya Karakkattil, PhD

  University of St. Augustine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caitlin Boyd

CONTACT

469-888-5170; cboyd@bswrehab.com

Sofiya Mistry

CONTACT

469-888-5170; SoMistry@bswrehab.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Occupational Therapist

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 6, 2021
• Study Start: June 17, 2021
• Primary Completion: December 15, 2022
• Study Completion: June 15, 2023
• Last Updated: March 10, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)