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StrokeNCT03574623

Therapies for Recovery of Hand Function After Stroke

A study testing Electrical Stimulator and Occupational Therapy in people with Stroke and Upper Extremity Paresis, run by MetroHealth Medical Center at 4 sites 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

After a stroke, it is very common to lose the ability to open the affected hand. The purpose of this study is to compare the effects of three different therapies on recovery of hand function after stroke and determine if any one is better than the other. Read more about this study

Who is it for?
Ages 21 to 90 years
Conditions the study is for
Stroke, Upper Extremity Paresis, Hemiplegia
What is being tested?
Electrical Stimulator and Occupational Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
4 sitesUnited States
Study dates
15 Feb 2019to 16 Oct 2024
Phase
Interventional
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 21 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 6 to 24 months since a first clinical cortical or subcortical, hemorrhagic or nonhemorrhagic stroke
  • unilateral upper limb hemiparesis with finger extensor strength of grade no more than 4 out of 5 on the Medical Research Council (MRC) scale
  • score of at least 1 and no more than 11 out of 14 on the hand section of the upper extremity Fugl-Meyer Assessment
  • adequate active movement of the shoulder and elbow to position the hand in the workspace for table-top task practice (necessary for the lab task practice sessions)
  • able to follow 3-stage commands
  • able to recall at least 2 of a list of 3 items after 30 minutes
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  • skin intact on the hemiparetic arm
  • surface stimulation of the paretic finger and thumb extensors produces functional hand opening without pain (this will exclude those who have too much flexor spasticity)
  • able to hear and respond to cues from stimulator
  • not receiving occupational therapy (no concomitant OT)
  • full voluntary opening/closing of the contralateral (less affected) hand
  • demonstrates ability to follow instructions for operating the stimulator or have a caregiver who will assist them

Who cannot join

  • co-existing neurologic diagnosis of peripheral nerve injury, Parkinson's disease, spinal cord injury, traumatic brain injury, or multiple sclerosis
  • uncontrolled seizure disorder
  • brainstem stroke
  • uncompensated hemineglect
  • severe shoulder or hand pain
  • insensate forearm or hand
Show all 15Show fewer
  • history of potentially fatal cardiac arrhythmias with hemodynamic instability
  • implanted electronic systems (e.g. pacemaker)
  • botulinum toxin injections to any upper extremity muscle within 3 months of enrolling
  • pregnant women due to unknown risks of surface NMES during pregnancy
  • lack of functional passive range of motion of the wrist or fingers of affected side
  • diagnosis (apart from stroke) that substantially affects paretic arm and hand function
  • deficits in communication that interfere with reasonable study participation
  • lacking sufficient visual acuity to see the stimulator's display
  • concurrent enrollment in another investigational study

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Emory University and Atlanta VA

    Atlanta, Georgia, 30322

  • Johns Hopkins University

    Baltimore, Maryland, 21205

  • MetroHealth Rehabilitation Institute

    Cleveland, Ohio, 44109

  • Kessler Foundation

    West Orange, New Jersey, 07052

Other trials in United States

About this study

Official title: Contralaterally Controlled FES Versus Cyclic NMES for Hand Function After Stroke

After a stroke, it is very common to lose the ability to open the affected hand. The purpose of this study is to compare the effects of three different therapies on recovery of hand function after stroke and determine if any one is better than the other.

Read the detailed description

A single-blinded randomized controlled trial will be carried out to assess and compare the effects of 12 weeks of Contralaterally Controlled Functional Electrical Stimulation (CCFES), Cyclic Neuromuscular Electrical Stimulation (cNMES), and Task Oriented Training. Dexterity, upper limb impairment, and activity limitation will be assessed at 0 (baseline), 12 (end of treatment), and 36 weeks. The treatment dose will be the same for all three groups: 10 sessions per week of self-administered treatment at home plus 2 sessions per week of group-specific occupational therapy in the lab.

Being tested
Electrical Stimulator, Occupational Therapy
Keywords
stroke, rehabilitation, therapy, electrical stimulation, hand
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.

  • Electrical StimulatorDevice

    An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to turn on and off in a repetitive cyclic fashion (i.e., cNMES) or be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES).

  • Occupational TherapyBehavioural

    Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.

Study groups in NCT03574623
Study groupRoleWhat they receive
CCFESExperimentalContralaterally Controlled Functional Electrical Stimulation (CCFES) uses an electrical stimulator and surface electrodes placed over the paretic finger and thumb extensors to deliver stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. Thus, volitional opening of the nonparetic hand produces stimulated opening of the paretic hand. During the lab visits, participants in the CCFES group will use CCFES to assist hand opening during occupational therapy task practice. During their home sessions, participants in the CCFES group will use CCFES to perform hand opening exercise.
Receives: Device: Electrical Stimulator; Behavioral: Occupational Therapy
cNMESActive comparatorCyclic Neuromuscular Electrical Stimulation (cNMES) uses an electrical stimulator and surface electrodes over the paretic finger and thumb extensors to deliver electrical stimulation to open the weak hand. The stimulation automatically turns on and off causing the weak hand to open repetitively for several seconds at a time. During the lab visits, participants in the cNMES group will receive occupational therapy task practice. During their home sessions, participants in the cNMES group will use cNMES to perform hand opening exercise.
Receives: Device: Electrical Stimulator; Behavioral: Occupational Therapy
Task Oriented TherapyActive comparatorTask Oriented Therapy (TOT) focuses on practicing using the weak hand to practice activities of daily living tasks. During the clinic visits, participants in the TOT group will receive occupational therapy task practice. During their home sessions, participants in the TOT group will practice using their hand to complete a list of tasks given to them by the therapist to ensure that the participant receives a high dose of task practice.
Receives: Behavioral: Occupational Therapy

What is being measured

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

  1. Change in Box and Blocks Test (BBT) at 6 Months Post-Treatment

    The BBT is a measure of hand dexterity. It is a count of how many blocks a patient can pick up, move over a barrier, and release in 60 seconds. The higher the score, the better the motor recovery.

    Measured: Baseline to 6 months post-treatment

Secondary outcomes (4)

  1. Change in Upper Extremity Fugl Meyer (UEFM) at 6 Months Post-Treatment

    The UEFM is a measure of upper limb motor impairment with a minimum score of 0 and maximum score of 66. The higher the score, the better the motor recovery.

    Measured: Baseline to 6 months post-treatment

  2. Change in Action Research Arm Test (ARAT) at 6 Months Post-Treatment

    The ARAT is a measure of arm and hand function with a minimum score of 0 and maximum score of 57. The higher the score, the better the motor recovery.

    Measured: Baseline to 6 months post-treatment

  3. Change in Stroke Upper Limb Capacity Scale (SULCS) at 6 Months Post-Treatment

    The SULCS is a measure of upper limb capacity with a minimum score of 0 and maximum score of 10. The higher the score, the better the motor recovery.

    Measured: Baseline to 6 months post-treatment

  4. Responder Rate

    Proportion of participants who had a gain of at least 6 points on the UEFM

    Measured: Baseline to 6 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 posted2 Jul 2018
  2. Study start15 Feb 2019
  3. Primary completion16 Oct 2024
  4. Study completion16 Oct 2024

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03574623
Sponsor's protocol ID
IRB17-00884
Other IDs
R01HD092351
Status last verified
Mar 2026
First submitted
20 Jun 2018
Last updated
20 Mar 2026
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Knutson JS, Friedl AS, Hansen KM, Harley MY, Hogan SD, Cunningham DA, Hisel TZ, Plow EB, Barrett AM, Raghavan P, Boukrina O, Nahab F, Gunzler DD, Chae J. Contralaterally Controlled Functional Electrical Stimulation for Upper Extremity Recovery Following Stroke: A Multisite Randomized Controlled Trial. Stroke. 2026 Feb;57(2):338-348. doi: 10.1161/STROKEAHA.125.052891. Epub 2025 Nov 13.

    PubMed 41230603

  • Knutson JS, Friedl AS, Hansen KM, Harley MY, Barrett AM, Raghavan P, Plow EB, Gunzler DD, Chae J. Efficacy of contralaterally controlled functional electrical stimulation compared to cyclic neuromuscular electrical stimulation and task-oriented training for recovery of hand function after stroke: study protocol for a multi-site randomized controlled trial. Trials. 2022 May 12;23(1):397. doi: 10.1186/s13063-022-06303-y.

    PubMed 35549747

Questions about this trial

What is this clinical trial studying?

A study testing Electrical Stimulator and Occupational Therapy in people with Stroke and Upper Extremity Paresis, run by MetroHealth Medical Center at 4 sites 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 12 inclusion and 15 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 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Yes. Results are posted in the registry (first posted 3 Mar 2026). 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?

Change in Box and Blocks Test (BBT) at 6 Months Post-Treatment (time frame: Baseline to 6 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 NCT03574623, which also lists 2 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 20 Mar 2026.

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