Cerebrovascular AccidentPhase 2NCT00369668
Post Stroke Hand Functions: Bilateral Movements and Electrical Stimulation Treatments
A Phase 2 study testing Bilateral movements and neuromuscular electrical stimulation in people with Cerebrovascular Accident and Hemiplegia, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study was to determine the effect of two amounts of treatment therapy on post stroke motor recovery in the arms. The therapy is bilateral movement training combined with electrical stimulation on the impaired limb. Read more about this study
- Who is it for?
- Ages 44 to 86 years
- Conditions the study is for
- Cerebrovascular Accident, Hemiplegia
- What is being tested?
- Bilateral movements and neuromuscular electrical stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Jun 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 44 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- an ability to complete 10º of wrist or finger extension from a 60 - 65 º flexed position
- score less than a 56 on the UE subscale of the Fugl-Meyer Assessment
- an ability to voluntarily activate slight movements in the wrist and fingers so that the EMG activity reaches a minimal level on the microprocessor for electrical stimulation to be activated
- unilateral, first stroke of ischemic or hemorrhagic origin in the carotid artery distribution
- free of major post stroke complications
- able to attend therapy 2 days/week or 4 days/week for 2 weeks
- score at least a 16 on the Mini Mental Status Examination
- able to discriminate sharp from dull and light touch using traditional sensation tests.
Who cannot join
- hemiparetic arm is insensate
- motor impairments from stroke on opposite side of body
- pre-existing neurological disorders such as Parkinson's disease, Multiple Sclerosis, or dementia
- Legal blindness or severe visual impairment; 5) Life expectancy less than one year
- Severe arthritis or orthopedic problems that limit passive ranges of motion of upper extremity (passive finger extension < 40º; passive wrist extension < 40º; passive elbow extension <40º; shoulder flexion/abduction < 80º)
- History of sustained alcoholism or drug abuse in the last six months
- Has pacemaker or other implanted device
- pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Motor Behavior Laboratory, University of Florida
Gainesville, Florida, 32611
About this study
Official title: Subacute Stroke Recovery (Upper Extremity Motor Function): Bimanual Coordination Training
The purpose of this study was to determine the effect of two amounts of treatment therapy on post stroke motor recovery in the arms. The therapy is bilateral movement training combined with electrical stimulation on the impaired limb.
Read the detailed description
Intense movement training (practice) with the affected arm after stroke has the potential to improve upper extremity (UE) function resulting from neuroplasticity changes in the motor cortex. However, the necessary and sufficient parameters of this therapy in humans have not been fully investigated. Delineation of the most efficacious and efficient therapy for promoting UE recovery post-stroke is necessary before effective clinical implementation of this therapy. The current compared the effects on motor function impairments for three bilateral movement groups involving two doses of treatment (i.e., bilateral training coupled with neuromuscular electrical stimulation) and a sham control. During the subacute recovery phase (3 - 6 months), patients who meet motor capabilities criteria will be randomly assigned to one of three groups: (a) low intensity: 90 minutes/session, 2 sessions/week 2 weeks; bilateral movement training coupled with active neuromuscular stimulation on the impaired wrist/fingers; (b) high intensity: 90 minutes/session, 4 sessions/week for 2 weeks; bilateral movement training coupled with active stimulation on the impaired wrist/finger extensors; and (c) control group (sham active stimulation). Patients' UE motor capabilities were assessed before treatment therapy began (pretest) and within the first week after the treatment therapy ended (posttest).
- Conditions
- Cerebrovascular Accident, Hemiplegia
- Being tested
- Bilateral movements and neuromuscular electrical stimulation, Bilateral movements and sham electrical stimulation
- Keywords
- Rehabilitation, Physical Therapy Techniques, Occupational Therapy, Upper Extremity; Motor skills
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral movements and neuromuscular electrical stimulationBehavioural
Also called functional electrical stimulation
Participants practice moving their paretic arm at the same time as they move their non-paretic arm in the same movement patterns. Neuromuscular electrical stimulation triggered by the participants' own contracting muscles is provided to the paretic arm during the movements. Training period was 4 times per week for 2 weeks.
Bilateral movements and neuromuscular electrical stimulationBehavioural
Also called functional electrical stimulation
Participants practice moving both their paretic and non-paretic arms at the same time in the same movement patterns. Neuromuscular electrical stimulation triggered by the participants' own contracting muscles is provided to the paretic arm during the movements. Training period was 2 times per week for 2 weeks.
Bilateral movements and sham electrical stimulationBehavioural
Also called functional electrical stimulation - sham
Participants practice moving both their paretic and non-paretic arms at the same time in the same movement patterns. Sham electrical stimulation (low level electrical stimulation that can be felt but is insufficient to trigger a muscle contraction) is provided to the paretic arm during the movement. Training period was 2 times per week for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity | Experimental | Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks. Receives: Behavioral: Bilateral movements and neuromuscular electrical stimulation |
| Low Intensity | Active comparator | Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks. Receives: Behavioral: Bilateral movements and neuromuscular electrical stimulation |
| Control | Active comparator | Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation Receives: Behavioral: Bilateral movements and sham electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box and Block Test; Data Collected = Number of Blocks Moved
A 60 second timed hand/arm manipulation test in which participants reach, grasp, lift, and release a 1" x 1" block of wood. They must lift a block from one side of a box, carry it over a low barrier and release the block into the other side of the box.
Measured: Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)
Fugl-Meyer Upper Extremity Motor Test
FM motor test assesses functional impairments post stroke as participants attempt various movements from daily activities. Minimum score = 0; maximum score = 66; lower scores indicate more impairments and higher scores indicate less impairments.
Measured: Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)
Fractionated Reaction Time
Premotor reaction times in milliseconds were recorded for the impaired arm of each participant in the three intervention (arm) groups. Premotor reaction time represents central processes. Lower times are faster reaction times, indicating less time to initiate a movement.
Measured: Baseline/pretest; posttest given between days 17-22 (posttest days 3-8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James H. Cauraugh, Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369668
- Sponsor's protocol ID
- 00061194
- Status last verified
- Apr 2012
- First submitted
- 24 Aug 2006
- Last updated
- 15 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Cauraugh JH, Coombes SA, Lodha N, Naik SK, Summers JJ. Upper extremity improvements in chronic stroke: coupled bilateral load training. Restor Neurol Neurosci. 2009;27(1):17-25. doi: 10.3233/RNN-2009-0455.
PubMed 19164850Cauraugh JH, Kim SB. Stroke motor recovery: active neuromuscular stimulation and repetitive practice schedules. J Neurol Neurosurg Psychiatry. 2003 Nov;74(11):1562-6. doi: 10.1136/jnnp.74.11.1562.
PubMed 14617717Cauraugh JH, Kim S. Two coupled motor recovery protocols are better than one: electromyogram-triggered neuromuscular stimulation and bilateral movements. Stroke. 2002 Jun;33(6):1589-94. doi: 10.1161/01.str.0000016926.77114.a6.
PubMed 12052996Cauraugh JH, Kim SB. Chronic stroke motor recovery: duration of active neuromuscular stimulation. J Neurol Sci. 2003 Nov 15;215(1-2):13-9. doi: 10.1016/s0022-510x(03)00169-2.
PubMed 14568122Richards LG, Stewart KC, Woodbury ML, Senesac C, Cauraugh JH. Movement-dependent stroke recovery: a systematic review and meta-analysis of TMS and fMRI evidence. Neuropsychologia. 2008 Jan 15;46(1):3-11. doi: 10.1016/j.neuropsychologia.2007.08.013. Epub 2007 Aug 24.
PubMed 17904594Lodha N, Naik SK, Coombes SA, Cauraugh JH. Force control and degree of motor impairments in chronic stroke. Clin Neurophysiol. 2010 Nov;121(11):1952-61. doi: 10.1016/j.clinph.2010.04.005.
PubMed 20435515Naik SK, Patten C, Lodha N, Coombes SA, Cauraugh JH. Force control deficits in chronic stroke: grip formation and release phases. Exp Brain Res. 2011 May;211(1):1-15. doi: 10.1007/s00221-011-2637-8. Epub 2011 Mar 30.
PubMed 21448576Cauraugh JH, Lodha N, Naik SK, Summers JJ. Bilateral movement training and stroke motor recovery progress: a structured review and meta-analysis. Hum Mov Sci. 2010 Oct;29(5):853-70. doi: 10.1016/j.humov.2009.09.004. Epub 2009 Nov 18.
PubMed 19926154Clark B, Whitall J, Kwakkel G, Mehrholz J, Ewings S, Burridge J. The effect of time spent in rehabilitation on activity limitation and impairment after stroke. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD012612. doi: 10.1002/14651858.CD012612.pub2.
PubMed 34695300
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subacute Stroke Recovery (Upper Extremity Motor Function): Bimanual Coordination Training
- ClinicalTrials.gov ID
- NCT00369668
- Acronym / sponsor ID
- 00061194
- Conditions
- Cerebrovascular Accident, Hemiplegia
- Keywords
- Rehabilitation, Physical Therapy Techniques, Occupational Therapy, Upper Extremity; Motor skills
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 29 Aug 2006 (estimated)
- Results
- Posted 11 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to determine the effect of two amounts of treatment therapy on post stroke motor recovery in the arms. The therapy is bilateral movement training combined with electrical stimulation on the impaired limb.
Detailed description
Intense movement training (practice) with the affected arm after stroke has the potential to improve upper extremity (UE) function resulting from neuroplasticity changes in the motor cortex. However, the necessary and sufficient parameters of this therapy in humans have not been fully investigated. Delineation of the most efficacious and efficient therapy for promoting UE recovery post-stroke is necessary before effective clinical implementation of this therapy. The current compared the effects on motor function impairments for three bilateral movement groups involving two doses of treatment (i.e., bilateral training coupled with neuromuscular electrical stimulation) and a sham control. During the subacute recovery phase (3 - 6 months), patients who meet motor capabilities criteria will be randomly assigned to one of three groups: (a) low intensity: 90 minutes/session, 2 sessions/week 2 weeks; bilateral movement training coupled with active neuromuscular stimulation on the impaired wrist/fingers; (b) high intensity: 90 minutes/session, 4 sessions/week for 2 weeks; bilateral movement training coupled with active stimulation on the impaired wrist/finger extensors; and (c) control group (sham active stimulation). Patients' UE motor capabilities were assessed before treatment therapy began (pretest) and within the first week after the treatment therapy ended (posttest).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Intensity | Experimental | Behavioral: Bilateral movements and neuromuscular electrical stimulationBilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks. |
| Low Intensity | Active comparator | Behavioral: Bilateral movements and neuromuscular electrical stimulationBilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks. |
| Control | Active comparator | Behavioral: Bilateral movements and sham electrical stimulationBilateral training moving both arms coupled with sham neuromuscular electrical stimulation |
Who may qualify
- Ages
- 44 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- an ability to complete 10º of wrist or finger extension from a 60 - 65 º flexed position
- score less than a 56 on the UE subscale of the Fugl-Meyer Assessment
- an ability to voluntarily activate slight movements in the wrist and fingers so that the EMG activity reaches a minimal level on the microprocessor for electrical stimulation to be activated
- unilateral, first stroke of ischemic or hemorrhagic origin in the carotid artery distribution
- free of major post stroke complications
Key exclusion criteria (8 listed)
- hemiparetic arm is insensate
- motor impairments from stroke on opposite side of body
- pre-existing neurological disorders such as Parkinson's disease, Multiple Sclerosis, or dementia
- Legal blindness or severe visual impairment; 5) Life expectancy less than one year
- Severe arthritis or orthopedic problems that limit passive ranges of motion of upper extremity (passive finger extension < 40º; passive wrist extension < 40º; passive elbow extension <40º; shoulder flexion/abduction < 80º)
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 |
|---|---|---|
| Bilateral movements and neuromuscular electrical stimulationAlso: functional electrical stimulationParticipants practice moving their paretic arm at the same time as they move their non-paretic arm in the same movement patterns. Neuromuscular electrical stimulation triggered by the participants' own contracting muscles is provided to the paretic arm during the movements. Training period was 4 times per week for 2 weeks. | Behavioural | High Intensity |
| Bilateral movements and neuromuscular electrical stimulationAlso: functional electrical stimulationParticipants practice moving both their paretic and non-paretic arms at the same time in the same movement patterns. Neuromuscular electrical stimulation triggered by the participants' own contracting muscles is provided to the paretic arm during the movements. Training period was 2 times per week for 2 weeks. | Behavioural | Low Intensity |
| Bilateral movements and sham electrical stimulationAlso: functional electrical stimulation - shamParticipants practice moving both their paretic and non-paretic arms at the same time in the same movement patterns. Sham electrical stimulation (low level electrical stimulation that can be felt but is insufficient to trigger a muscle contraction) is provided to the paretic arm during the movement. Training period was 2 times per week for 2 weeks. | Behavioural | Control |
Primary outcome
Box and Block Test; Data Collected = Number of Blocks Moved
Time frame: Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)
A 60 second timed hand/arm manipulation test in which participants reach, grasp, lift, and release a 1" x 1" block of wood. They must lift a block from one side of a box, carry it over a low barrier and release the block into the other side of the box.
Fugl-Meyer Upper Extremity Motor Test
Time frame: Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)
FM motor test assesses functional impairments post stroke as participants attempt various movements from daily activities. Minimum score = 0; maximum score = 66; lower scores indicate more impairments and higher scores indicate less impairments.
Fractionated Reaction Time
Time frame: Baseline/pretest; posttest given between days 17-22 (posttest days 3-8)
Premotor reaction times in milliseconds were recorded for the impaired arm of each participant in the three intervention (arm) groups. Premotor reaction time represents central processes. Lower times are faster reaction times, indicating less time to initiate a movement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19164850Cauraugh JH, Coombes SA, Lodha N, Naik SK, Summers JJ. Upper extremity improvements in chronic stroke: coupled bilateral load training. Restor Neurol Neurosci. 2009;27(1):17-25. doi: 10.3233/RNN-2009-0455.
- Results publication: PubMed 14617717Cauraugh JH, Kim SB. Stroke motor recovery: active neuromuscular stimulation and repetitive practice schedules. J Neurol Neurosurg Psychiatry. 2003 Nov;74(11):1562-6. doi: 10.1136/jnnp.74.11.1562.
- Results publication: PubMed 12052996Cauraugh JH, Kim S. Two coupled motor recovery protocols are better than one: electromyogram-triggered neuromuscular stimulation and bilateral movements. Stroke. 2002 Jun;33(6):1589-94. doi: 10.1161/01.str.0000016926.77114.a6.
- Results publication: PubMed 14568122Cauraugh JH, Kim SB. Chronic stroke motor recovery: duration of active neuromuscular stimulation. J Neurol Sci. 2003 Nov 15;215(1-2):13-9. doi: 10.1016/s0022-510x(03)00169-2.
- Results publication: PubMed 17904594Richards LG, Stewart KC, Woodbury ML, Senesac C, Cauraugh JH. Movement-dependent stroke recovery: a systematic review and meta-analysis of TMS and fMRI evidence. Neuropsychologia. 2008 Jan 15;46(1):3-11. doi: 10.1016/j.neuropsychologia.2007.08.013. Epub 2007 Aug 24.
- Results publication: PubMed 20435515Lodha N, Naik SK, Coombes SA, Cauraugh JH. Force control and degree of motor impairments in chronic stroke. Clin Neurophysiol. 2010 Nov;121(11):1952-61. doi: 10.1016/j.clinph.2010.04.005.
- Results publication: PubMed 21448576Naik SK, Patten C, Lodha N, Coombes SA, Cauraugh JH. Force control deficits in chronic stroke: grip formation and release phases. Exp Brain Res. 2011 May;211(1):1-15. doi: 10.1007/s00221-011-2637-8. Epub 2011 Mar 30.
- Results publication: PubMed 19926154Cauraugh JH, Lodha N, Naik SK, Summers JJ. Bilateral movement training and stroke motor recovery progress: a structured review and meta-analysis. Hum Mov Sci. 2010 Oct;29(5):853-70. doi: 10.1016/j.humov.2009.09.004. Epub 2009 Nov 18.
- Derived from this study: PubMed 34695300Clark B, Whitall J, Kwakkel G, Mehrholz J, Ewings S, Burridge J. The effect of time spent in rehabilitation on activity limitation and impairment after stroke. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD012612. doi: 10.1002/14651858.CD012612.pub2.
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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.
James H. Cauraugh, Ph.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bilateral movements and neuromuscular electrical stimulation in people with Cerebrovascular Accident and Hemiplegia, run by University of Florida 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 8 inclusion and 8 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 15 Jun 2012. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Box and Block Test; Data Collected = Number of Blocks Moved (time frame: Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)). The study lists 3 primary outcomes in all. 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 NCT00369668, which also lists 9 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 15 Jun 2012.