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Stroke, AcutePhase 1/2NCT00565045

Treatments for Recovery of Hand Function in Acute Stroke Survivors

A Phase 1/2 study testing Neuromuscular electrical stimulator in people with Stroke, Acute and Stroke, run by MetroHealth Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Impaired hand function is one of the most frequently persisting consequences of stroke. The purpose of this study is to investigate whether two different types of treatment improve recovery of hand function after stroke. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke, Acute, Stroke, Hemiparesis
What is being tested?
Neuromuscular electrical stimulator
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
Jul 2007to Apr 2010
Phase
Phase 1/2
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 80
  • Within 6 months of first clinical hemorrhagic or nonhemorrhagic stroke
  • Cortical or subcortical stroke
  • Unilateral upper extremity hemiparesis with severe finger extensor and flexor paresis (<= grade 4 on Medical Research Council (MRC) scale)
  • Adequate movement of the shoulder and elbow to allow volitional positioning of the affected hand in the workspace.
  • Surface NMES of finger and thumb extensors produces functional hand opening without pain
Show all 13Show fewer
  • Full volitional opening of the contralateral hand of the unimpaired side.
  • Able to follow 3 stage commands
  • Able to remember at least 2 of 3 items after 30 minutes
  • Able to hear and respond (by opening the less affected hand) to auditory cues issued from the stimulator?
  • Caregiver available and willing to help assist with the device and home regimen and ensure compliance
  • Skin intact on hemiparetic arm
  • Medically stable

Who cannot join

  • Insensate forearm and/or hand
  • Edema of the affected forearm and/or hand
  • History of potentially fatal cardiac arrhythmias.
  • Cardiac pacemakers or any other implanted electronic systems
  • Pregnant women
  • Uncontrolled seizure disorder
Show all 17Show fewer
  • Severely impaired cognition or comprehension
  • Uncompensated hemineglect
  • Severe depression (>= 13 on Beck Depression Inventory Fast Screen)
  • Ipsilateral lower motor neuron lesion
  • Parkinson's Disease
  • Spinal cord injury
  • Traumatic brain injury
  • Multiple sclerosis
  • Lack of functional passive range of motion of the wrist or fingers of affected side
  • Severe shoulder or hand pain (unable to volitionally position hand in the workspace without pain)
  • Intramuscular botulinum toxin injections in upper extremity muscle in the last 3 months

Trial locations and contacts

1 site in 1 country.

United States1 site

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

Other trials in United States

About this study

Official title: Contralaterally Controlled Functional Electrical Stimulation for Hemiparetic Hand

Impaired hand function is one of the most frequently persisting consequences of stroke. The purpose of this study is to investigate whether two different types of treatment improve recovery of hand function after stroke.

Read the detailed description

Loss of hand function is common after stroke. Previous research suggests that treatments that focus on movement of both hands at the same time or treatments that electrically stimulate the paretic (weak) hand muscles may help the recovery of hand function after stroke. In this study, two electrical stimulation treatments will be compared in their effectiveness in restoring hand movement and hand function. One of the treatments is stimulation only, and the other is stimulation linked to movement of the contralateral hand.

Study participants will be stroke survivors who are enrolled while they are still within their first 6 months after their stroke. After enrolling, their hand movement and function will be tested. Then they will be randomly assigned to one of the two treatments. Each treatment will last 6 weeks. The treatment will require the participant to perform specific exercises at home for a total of 2 hours every day and to come to the laboratory twice a week for study-related occupational therapy. At the end of the 6-week treatment, tests of hand movement and hand function will be repeated. The same tests will be repeated again at 1 and 3 months after the end of treatment to see if the effects of the treatment persist as time goes on. Changes in upper extremity impairment and activity limitation will be compared across treatment groups.

Being tested
Neuromuscular electrical stimulator
Keywords
hand, stroke, hemiplegia, electrical stimulation, recovery
Medical subject headings
Stroke, Paresis, Hemiplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuromuscular electrical stimulatorDevice

    Intervention Characteristics Common to Both Groups

    • 6-week intervention
    1. Home "exercise", daily
    2. Exercise (at home) 2 sessions/day
    3. A "session" consists of 3 (for CCFES) or 4 (for cNMES) 15-min sets separated by 5 min rest
    4. A "set" entails hand opening, closing, and relaxing in response or synchrony to light and sound cues and according to group-specific instructions
    5. Lab "therapy", 2x/week
    6. Two 1.5-hr sessions/week, working on functional hand tasks and tracking task (if possible).
Study groups in NCT00565045
Study groupRoleWhat they receive
CCFESExperimentalCCFES - Contralaterally Controlled Functional Electrical Stimulation * Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand * A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity * Therapy sessions are done with the subject being assisted by the CCFES system.
Receives: Device: Neuromuscular electrical stimulator
cNMESActive comparatorcNMES - Cyclic NeuroMuscular Electrical Stimulation. * Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject. * Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation * Therapy sessions are done without the stimulation system
Receives: Device: Neuromuscular electrical stimulator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Voluntary Finger Extension Angle (a Measure of Hand Impairment)

    A custom-built electrogoniometer recorded the angles of the metacarpophalangeal (MP) and proximal interphalangeal (PIP) joints of the index finger simultaneously. Participants were seated with the forearm and wrist supported and stabilized in a neutral posture. From this resting postion, they were instructed to extend their fingers as fully as possible in response to a 4-sec audio cue. The MP and PIP angles were added together, providing a composite measure of degree of finger extension, where 0 degrees corresponds to full extension of the MP and PIP joints. The more negative the angle, the more flexed the finger.

    Measured: 3 months post-treatment.

Secondary outcomes (4)

  1. Finger Tracking Error

    A 30-sec 0.1Hz sine wave track scrolled from right to left on a computer screen in front of the participant. The amplitude of the sine wave was scaled to match the middle 70% of the participant's voluntary finger active range of motion (AROM). A cursor on the computer screen moved up and down as the participant extended and flexed their index finger. The task was to trace the scrolling sine wave with the cursor. Tracking error was the average vertical distance between the cursor and the target trace. Since the track was scaled to the participant's finger AROM, the distance between the cursor and the target trace (and therefore the tracking error) is in units corresponding to the percentage (%) of the participant's finger active range of motion (AROM), hereafter abbreviated %AROM.

    Measured: 3 months post-treatment.

  2. Box and Blocks Score

    The number of blocks picked up and moved across a barrier in 60 seconds

    Measured: 3 months post-treatment.

  3. Arm Motor Abilities Test

    The Arm Motor Abilities Test (AMAT) score is an average across 9 different compound activities of daily living (ADL) tasks composed of 1 to 3 component tasks, each of which was scored by a therapist using a 0 to 5 ordinal scale: 0, no attempt to use affected limb; 1, attempt to use affected limb but it doesn't participate functionally; 2, affected limb is used only as a helper or stabilizer; 3, affected limb is used slowly or within synergy patterns; 4, affected limb use almost normal; 5, normal use. Each of the 9 tasks is scored and then the average score across the 9 tasks is calculated, with a range of 0 to 5.

    Measured: 3 months post-treatment.

  4. Fugl-Meyer Assessment (Upper Extremity)

    The participant was asked to perform specific coordinated and isolated shoulder, elbow, wrist, and hand movements. Each movement was rated by a therapist using a 3-point ordinal scale: 0, cannot perform; 1, perform partially; 2, perform fully) and summed to produce an overall score, with a range of 0 to 66 (the higher the score the better).

    Measured: 3 months post-treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionApr 2010
  4. Study completionApr 2010

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00565045
Sponsor's protocol ID
R21HD054749
Status last verified
Nov 2018
First submitted
27 Nov 2007
Last updated
19 Dec 2018
Data monitoring committee
No
Individual data sharing
No

Publications

  • Knutson JS, Harley MY, Hisel TZ, Chae J. Improving hand function in stroke survivors: a pilot study of contralaterally controlled functional electric stimulation in chronic hemiplegia. Arch Phys Med Rehabil. 2007 Apr;88(4):513-20. doi: 10.1016/j.apmr.2007.01.003.

    PubMed 17398254

  • Glanz M, Klawansky S, Stason W, Berkey C, Chalmers TC. Functional electrostimulation in poststroke rehabilitation: a meta-analysis of the randomized controlled trials. Arch Phys Med Rehabil. 1996 Jun;77(6):549-53. doi: 10.1016/s0003-9993(96)90293-2.

    PubMed 8831470

  • Chae J, Bethoux F, Bohine T, Dobos L, Davis T, Friedl A. Neuromuscular stimulation for upper extremity motor and functional recovery in acute hemiplegia. Stroke. 1998 May;29(5):975-9. doi: 10.1161/01.str.29.5.975.

    PubMed 9596245

  • Luft AR, McCombe-Waller S, Whitall J, Forrester LW, Macko R, Sorkin JD, Schulz JB, Goldberg AP, Hanley DF. Repetitive bilateral arm training and motor cortex activation in chronic stroke: a randomized controlled trial. JAMA. 2004 Oct 20;292(15):1853-61. doi: 10.1001/jama.292.15.1853.

    PubMed 15494583

  • Whitall J, McCombe Waller S, Silver KH, Macko RF. Repetitive bilateral arm training with rhythmic auditory cueing improves motor function in chronic hemiparetic stroke. Stroke. 2000 Oct;31(10):2390-5. doi: 10.1161/01.str.31.10.2390.

    PubMed 11022069

  • Mudie MH, Matyas TA. Can simultaneous bilateral movement involve the undamaged hemisphere in reconstruction of neural networks damaged by stroke? Disabil Rehabil. 2000 Jan 10-20;22(1-2):23-37. doi: 10.1080/096382800297097.

    PubMed 10661755

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Neuromuscular electrical stimulator in people with Stroke, Acute and Stroke, run by MetroHealth Medical Center 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 13 inclusion and 17 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 19 Dec 2018. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 10 Jul 2013). 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?

Maximum Voluntary Finger Extension Angle (a Measure of Hand Impairment) (time frame: 3 months post-treatment.). 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 NCT00565045, which also lists 6 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 19 Dec 2018.

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