StrokeNCT02887872
Electrical Stimulation and a Dynamic Orthosis for Stroke Recovery
A study testing Electrical stimulation-dynamic hand orthosis in people with Stroke, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Electrical stimulation-dynamic hand orthosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- having one or more contraindicated conditions to receive electrical stimulation (implanted pacemaker/electronics, surgical hardware, tumors, cellulitis, open wounds, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: Combining Electrical Stimulation and a Dynamic Hand Orthosis for Functional Recovery in Chronic Stroke
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Electrical stimulation-dynamic hand orthosis
- Keywords
- stroke, upper extremity function, rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical stimulation-dynamic hand orthosisOther
Also called Empi 300PV neuromuscular electrical stimulation unit, SaeboFlex dynamic hand orthosis
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Electrical stimulation-dynamic hand orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Strength of grip in affected hand measured through dynamometry
Measured: 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
Range of motion (flexion/extension)of affected wrist and 3rd metacarpal joint measured through goniometry performed by blinded evaluator
Measured: 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
Root mean square and time course of electromyographical (EMG) signal of extensor muscles persisting after auditory cue to release grasp
Measured: Before and after 6-week (30 visits) electrical stimulation-dynamic hand orthosis intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startMay 2011
- Primary completionDec 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara M. Doucet, PhD, Principal investigator, Louisiana State University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887872
- Sponsor's protocol ID
- 11-020
- Status last verified
- Aug 2016
- First submitted
- 16 Aug 2016
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual data are confidential.
Publications
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.
PubMed 15480949Barry 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.
PubMed 22354108de 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.
PubMed 18678569Doucet BM, Griffin L. Variable stimulation patterns for poststroke hemiplegia. Muscle Nerve. 2009 Jan;39(1):54-62. doi: 10.1002/mus.21114.
PubMed 19086075Doucet 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.
PubMed 22737049Hoffman HB, Blakey GL. New design of dynamic orthoses for neurological conditions. NeuroRehabilitation. 2011;28(1):55-61. doi: 10.3233/NRE-2011-0632.
PubMed 21335678Lee 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.
PubMed 26520398Page 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.
PubMed 22289227Persch 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.
PubMed 22728015Quandt 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.
PubMed 25276333Singer 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.
PubMed 23963340Sullivan 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.
PubMed 26084321Sun 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.
PubMed 26244605Woo 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.
PubMed 23112278
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Electrical Stimulation and a Dynamic Hand Orthosis for Functional Recovery in Chronic Stroke
- ClinicalTrials.gov ID
- NCT02887872
- Acronym / sponsor ID
- 11-020
- Conditions
- Stroke
- Keywords
- stroke, upper extremity function, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 2 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot data | Experimental | Other: Electrical stimulation-dynamic hand orthosisFour 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. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- having one or more contraindicated conditions to receive electrical stimulation (implanted pacemaker/electronics, surgical hardware, tumors, cellulitis, open wounds, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical stimulation-dynamic hand orthosisAlso: Empi 300PV neuromuscular electrical stimulation unit, SaeboFlex dynamic hand orthosisEach 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. | Other | Pilot data |
Primary outcome
Change from baseline performance of functional tasks to post-intervention performance of functional tasks
Time frame: Before and after 6-week (30 visits) electrical stimulation-dynamic hand orthosis intervention
Motor and process scores of the Assessment of Motor and Process Skills (AMPS) test
3 secondary outcomes
Change from baseline grip strength to post-intervention grip strength
Time frame: 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
Time frame: 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
Time frame: Before and after 6-week (30 visits) electrical stimulation-dynamic hand orthosis intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Results publication: PubMed 15480949Aoyagi 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.
- Results publication: PubMed 22354108Barry 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.
- Results publication: PubMed 18678569de 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 publication: PubMed 19086075Doucet BM, Griffin L. Variable stimulation patterns for poststroke hemiplegia. Muscle Nerve. 2009 Jan;39(1):54-62. doi: 10.1002/mus.21114.
- Results publication: PubMed 22737049Doucet 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.
- Results publication: PubMed 21335678Hoffman HB, Blakey GL. New design of dynamic orthoses for neurological conditions. NeuroRehabilitation. 2011;28(1):55-61. doi: 10.3233/NRE-2011-0632.
- Results publication: PubMed 26520398Lee 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 publication: PubMed 22289227Page 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 publication: PubMed 22728015Persch 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 publication: PubMed 25276333Quandt 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.
- Results publication: PubMed 23963340Singer 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.
- Results publication: PubMed 26084321Sullivan 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.
- Individual participant dataSharing planned: No. Individual data are confidential.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara M. Doucet, PhD principal investigator
Louisiana State University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical stimulation-dynamic hand orthosis in people with Stroke, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline performance of functional tasks to post-intervention performance of functional tasks (time frame: Before and after 6-week (30 visits) electrical stimulation-dynamic hand orthosis intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02887872, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2019.