Electrical Stimulation and a Dynamic Orthosis for Stroke Recovery

NCT02887872 | Completed

• 1 other identifier: 11-020
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To explore the effectiveness of a combined neuromuscular electrical stimulation (ES) and dynamic hand orthosis (DHO) regimen used with a small group of persons with chronic stroke in improving ability to perform daily tasks. Method: Four participants with chronic stroke participated in the combined ES-DHO regimen using the affected upper extremity (UE) five times (5X) per week for 6 weeks. Outcome measures included grip strength, range of motion (ROM), and analysis of muscle activation/deactivation during release of grasp through electromyography (EMG). Ability to perform daily functional tasks was assessed using the Assessment of Motor and Process Skills (AMPS). Results: Preliminary results suggest that improvements in strength, ROM and grasp deactivation are possible with the combined ES-DHO regimen. Ability to perform daily functional tasks improved in all participants. Conclusion: Results should be interpreted cautiously due to the pilot nature of the study and small participant number. Further research in this area is warranted.

Conditions

Stroke

Keywords

stroke; upper extremity function; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change from baseline performance of functional tasks to post-intervention performance of functional tasks

  Motor and process scores of the Assessment of Motor and Process Skills (AMPS) test

  Before and after 6-week (30 visits) electrical stimulation-dynamic hand orthosis intervention

Secondary Outcomes (3)

• Change from baseline grip strength to post-intervention grip strength

  Before and after 6-week (30 visits) electrical stimulation-dynamic hand orthosis intervention

• Change from baseline range of motion in wrist and metacarpal joint to post-intervention range of motion in wrist and metacarpal joint

  Before and after 6-week (30 visits) electrical stimulation-dynamic hand orthosis intervention

• Change from baseline forearm muscle activation/deactivation to post-intervention forearm muscle activation/deactivation

  Before and after 6-week (30 visits) electrical stimulation-dynamic hand orthosis intervention

Study Arms (1)

Pilot data

EXPERIMENTAL

Four participants with chronic stroke participated in a 45-minute combined electrical stimulation-dynamic hand orthosis regimen using the affected upper extremity (UE) 5X/week for 6 weeks.

Other: Electrical stimulation-dynamic hand orthosis

Interventions

Electrical stimulation-dynamic hand orthosis OTHER

Each participant participated in the electrical stimulation-dynamic hand orthosis regimen. Repetitive grasp/release motions were performed for 30 minutes while wearing the dynamic hand orthosis. This was followed by 15 minutes of electrical stimulation applied to forearm extensor muscles. This regimen was performed daily, 5X/week for 6 weeks.

Also known as: Empi 300PV neuromuscular electrical stimulation unit, SaeboFlex dynamic hand orthosis

Pilot data

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have a diagnosis of ischemic or hemorrhagic stroke that occurred at least six months prior to date of participation;
• be between 20 and 85 years of age;
• exhibit a minimal amount of upper extremity movement (approximately 10° active wrist or digit movement);
• be able to communicate orally and provide informed consent; and
• be able to comprehend the responsibilities and procedures related to the study.

You may not qualify if:

• (1) having one or more contraindicated conditions to receive electrical stimulation (implanted pacemaker/electronics, surgical hardware, tumors, cellulitis, open wounds, etc.)

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Publications (14)

• Aoyagi Y, Tsubahara A. Therapeutic orthosis and electrical stimulation for upper extremity hemiplegia after stroke: a review of effectiveness based on evidence. Top Stroke Rehabil. 2004 Summer;11(3):9-15. doi: 10.1310/6Q5Q-69PU-NLQ9-AVMR.

  PMID: 15480949 RESULT

• Barry JG, Ross SA, Woehrle J. Therapy incorporating a dynamic wrist-hand orthosis versus manual assistance in chronic stroke: a pilot study. J Neurol Phys Ther. 2012 Mar;36(1):17-24. doi: 10.1097/NPT.0b013e318246203e.

  PMID: 22354108 RESULT

• de Kroon JR, IJzerman MJ. Electrical stimulation of the upper extremity in stroke: cyclic versus EMG-triggered stimulation. Clin Rehabil. 2008 Aug;22(8):690-7. doi: 10.1177/0269215508088984.

  PMID: 18678569 RESULT

• Doucet BM, Griffin L. Variable stimulation patterns for poststroke hemiplegia. Muscle Nerve. 2009 Jan;39(1):54-62. doi: 10.1002/mus.21114.

  PMID: 19086075 RESULT

• Doucet BM, Lam A, Griffin L. Neuromuscular electrical stimulation for skeletal muscle function. Yale J Biol Med. 2012 Jun;85(2):201-15. Epub 2012 Jun 25.

  PMID: 22737049 RESULT

• Hoffman HB, Blakey GL. New design of dynamic orthoses for neurological conditions. NeuroRehabilitation. 2011;28(1):55-61. doi: 10.3233/NRE-2011-0632.

  PMID: 21335678 RESULT

• Lee YY, Lin KC, Cheng HJ, Wu CY, Hsieh YW, Chen CK. Effects of combining robot-assisted therapy with neuromuscular electrical stimulation on motor impairment, motor and daily function, and quality of life in patients with chronic stroke: a double-blinded randomized controlled trial. J Neuroeng Rehabil. 2015 Oct 31;12:96. doi: 10.1186/s12984-015-0088-3.

  PMID: 26520398 RESULT

• Page SJ, Levin L, Hermann V, Dunning K, Levine P. Longer versus shorter daily durations of electrical stimulation during task-specific practice in moderately impaired stroke. Arch Phys Med Rehabil. 2012 Feb;93(2):200-6. doi: 10.1016/j.apmr.2011.09.016.

  PMID: 22289227 RESULT

• Persch AC, Page SJ, Murray C. Paretic upper extremity movement gains are retained 3 months after training with an electrical stimulation neuroprosthesis. Arch Phys Med Rehabil. 2012 Nov;93(11):2122-5. doi: 10.1016/j.apmr.2012.06.006. Epub 2012 Jun 20.

  PMID: 22728015 RESULT

• Quandt F, Hummel FC. The influence of functional electrical stimulation on hand motor recovery in stroke patients: a review. Exp Transl Stroke Med. 2014 Aug 21;6:9. doi: 10.1186/2040-7378-6-9. eCollection 2014.

  PMID: 25276333 RESULT

• Singer BJ, Vallence AM, Cleary S, Cooper I, Loftus AM. The effect of EMG triggered electrical stimulation plus task practice on arm function in chronic stroke patients with moderate-severe arm deficits. Restor Neurol Neurosci. 2013;31(6):681-91. doi: 10.3233/RNN-130319.

  PMID: 23963340 RESULT

• Sullivan J, Girardi M, Hensley M, Rohaus J, Schewe C, Whittey C, Hansen P, Muir K. Improving arm function in chronic stroke: a pilot study of sensory amplitude electrical stimulation via glove electrode during task-specific training. Top Stroke Rehabil. 2015 Jun;22(3):169-75. doi: 10.1179/1074935714Z.0000000007. Epub 2015 Jan 26.

  PMID: 26084321 RESULT

• Sun Y, Boots J, Zehr EP. The lingering effects of a busted myth--false time limits in stroke rehabilitation. Appl Physiol Nutr Metab. 2015 Aug;40(8):858-61. doi: 10.1139/apnm-2014-0523.

  PMID: 26244605 RESULT

• Woo Y, Jeon H, Hwang S, Choi B, Lee J. Kinematics variations after spring-assisted orthosis training in persons with stroke. Prosthet Orthot Int. 2013 Aug;37(4):311-6. doi: 10.1177/0309364612461050. Epub 2012 Oct 30.

  PMID: 23112278 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Barbara M. Doucet, PhD

  Louisiana State University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: September 2, 2016
• Study Start: May 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: October 1, 2013
• Last Updated: May 29, 2019

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)