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Electrical Stimulation and a Dynamic Orthosis for Stroke Recovery

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electrical stimulation-dynamic hand orthosis
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, upper extremity function, rehabilitation

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

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

Exclusion Criteria:

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

Sites / Locations

  • University of Texas Medical Branch

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pilot data

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline grip strength to post-intervention grip strength
Strength of grip in affected hand measured through dynamometry
Change from baseline range of motion in wrist and metacarpal joint to post-intervention range of motion in wrist and metacarpal joint
Range of motion (flexion/extension)of affected wrist and 3rd metacarpal joint measured through goniometry performed by blinded evaluator
Change from baseline forearm muscle activation/deactivation to post-intervention forearm muscle activation/deactivation
Root mean square and time course of electromyographical (EMG) signal of extensor muscles persisting after auditory cue to release grasp

Full Information

First Posted
August 16, 2016
Last Updated
May 24, 2019
Sponsor
The University of Texas Medical Branch, Galveston
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1. Study Identification

Unique Protocol Identification Number
NCT02887872
Brief Title
Electrical Stimulation and a Dynamic Orthosis for Stroke Recovery
Official Title
Combining Electrical Stimulation and a Dynamic Hand Orthosis for Functional Recovery in Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The purpose of this pilot study was to explore the outcomes on performance of functional daily living tasks following a six-week combined regimen using ES and the SaeboFlex orthosis with repetitive task training (RTT) in four persons with chronic stroke. Functional outcomes were assessed before and after (pre-post design) a six-week combined treatment regimen using the DHO during RTT followed by a regimen of ES. Feasibility and logistics for translation of these preliminary results to a larger, more comprehensive controlled trial were explored. Participants donned the orthosis on the affected upper extremity with therapist assistance and performed the RTT grasp/release practice daily for 30 minutes, 5X/week for 6 weeks (30 sessions).Following completion of the grasp/release practice, ES to the finger extensor muscles was provided for 15 minutes. Goniometry to measure range of motion (ROM) at wrist and fingers, dynamometry to measure hand strength, electromyography (EMG) collection to measure muscle activation/deactivation, and AMPS testing to measure functional activity performance were performed before starting the intervention (baseline) and one day after the final training session. Gains in grip strength, 3rd metacarpophalangeal (MP) flexion, AMPS motor score, and improved deactivation of grasp were observed in all participants. Wrist extension, 3rd MP extension, AMPS process score, EMG root mean square (RMS) and time to release grasp improved in three of the four participants.These preliminary pilot results begin to suggest that gains can be made in impairment areas of strength, ROM, and the functional movement pattern of grasp release with a combined ES-DHO program in individuals with chronic stroke. Perhaps most importantly, the results may indicate that this type of training may translate to improvement in performance of daily living tasks. Completion of this work suggests that a larger trial is feasible and logistically able to be performed. The preliminary data are limited in that only four volunteers with chronic stroke were studied, so the small numbers involved restrict generalizations of effectiveness and comprehensive analysis of outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, upper extremity function, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pilot data
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Electrical stimulation-dynamic hand orthosis
Other Intervention Name(s)
Empi 300PV neuromuscular electrical stimulation unit, SaeboFlex dynamic hand orthosis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline performance of functional tasks to post-intervention performance of functional tasks
Description
Motor and process scores of the Assessment of Motor and Process Skills (AMPS) test
Time Frame
Before and after 6-week (30 visits) electrical stimulation-dynamic hand orthosis intervention
Secondary Outcome Measure Information:
Title
Change from baseline grip strength to post-intervention grip strength
Description
Strength of grip in affected hand measured through dynamometry
Time Frame
Before and after 6-week (30 visits) electrical stimulation-dynamic hand orthosis intervention
Title
Change from baseline range of motion in wrist and metacarpal joint to post-intervention range of motion in wrist and metacarpal joint
Description
Range of motion (flexion/extension)of affected wrist and 3rd metacarpal joint measured through goniometry performed by blinded evaluator
Time Frame
Before and after 6-week (30 visits) electrical stimulation-dynamic hand orthosis intervention
Title
Change from baseline forearm muscle activation/deactivation to post-intervention forearm muscle activation/deactivation
Description
Root mean square and time course of electromyographical (EMG) signal of extensor muscles persisting after auditory cue to release grasp
Time Frame
Before and after 6-week (30 visits) electrical stimulation-dynamic hand orthosis intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria: (1) having one or more contraindicated conditions to receive electrical stimulation (implanted pacemaker/electronics, surgical hardware, tumors, cellulitis, open wounds, etc.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara M. Doucet, PhD
Organizational Affiliation
Louisiana State University Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual data are confidential.
Citations:
PubMed Identifier
15480949
Citation
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Results Reference
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22354108
Citation
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.
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18678569
Citation
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.
Results Reference
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PubMed Identifier
19086075
Citation
Doucet BM, Griffin L. Variable stimulation patterns for poststroke hemiplegia. Muscle Nerve. 2009 Jan;39(1):54-62. doi: 10.1002/mus.21114.
Results Reference
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22737049
Citation
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.
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21335678
Citation
Hoffman HB, Blakey GL. New design of dynamic orthoses for neurological conditions. NeuroRehabilitation. 2011;28(1):55-61. doi: 10.3233/NRE-2011-0632.
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PubMed Identifier
26520398
Citation
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.
Results Reference
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PubMed Identifier
22289227
Citation
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.
Results Reference
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PubMed Identifier
22728015
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
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23963340
Citation
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.
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Citation
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.
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Citation
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Electrical Stimulation and a Dynamic Orthosis for Stroke Recovery

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