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StrokeNCT05621980

Finger Movement Training After Stroke

A study testing Actuated Virtual Keyboard (AVK) system and Occupational Therapy (OT) in people with Stroke, run by North Carolina State University 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

Human development as a species has been strongly associated with the ability to dexterously manipulate objects and tools. Unfortunately, current therapy efforts typically fail to restore fine manual control after stroke. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Stroke
What is being tested?
Actuated Virtual Keyboard (AVK) system and Occupational Therapy (OT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
5 Sep 2023to 31 Jul 2025
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A single, unilateral stroke 2-18 months prior to enrollment
  • Moderate to mild hand impairment, as determined by a rating of Stage 4-6 on the Stage of Hand section of the Chedoke-McMaster Stroke Assessment
  • Visual capacity to discern specific shapes on the computer screen
  • Capacity to provide informed consent

Who cannot join

  • Rigid contractures in the joints of the upper limbs, or orthopedic issues precluding joint movement
  • Hemispatial neglect (as assessed by the Behavioral Inattention Test)
  • Excessive pain in the paretic upper limb (visual analog scale of shoulder pain < 70)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hand Rehabilitation Lab

    Raleigh, North Carolina, 27695

Other trials in United States

About this study

Official title: A Multimodal Intervention to Improve Manual Dexterity in Subacute Stroke Survivors

Human development as a species has been strongly associated with the ability to dexterously manipulate objects and tools. Unfortunately, current therapy efforts typically fail to restore fine manual control after stroke. The goal of this study is to evaluate a new intervention that would combine targeted electrical stimulation of selected nerves with use a soft, pneumatically actuated hand exoskeleton to enhance repetitive practice of independent movements of the fingers and thumb in order to improve rehabilitation of hand function after stroke.

The investigators will recruit stroke survivors in the subacute phase of recovery (2-18 months post-stroke). These participants will be involved in a 5-week intervention involving 15 training sessions. During these sessions, participants will train independent movement of the digits of the paretic hand. Evaluation of motor control of the paretic hand will occur prior to initiation of training, at the midpoint of the training period, after completion of training, and one month later.

Conditions
Stroke
Being tested
Actuated Virtual Keyboard (AVK) system, Occupational Therapy (OT)
Keywords
stroke, FES, virtual reality, rehabilitation
Medical subject headings
Stroke

What participants receive

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

  • Actuated Virtual Keyboard (AVK) systemBehavioural

    The participant controls an avatar hand by the movement of their own digits. Each avatar digit corresponds to a given virtual key. "Sufficient" digit flexion results in "playing" of that key, with visual and auditory feedback of key strike. Participants will wear a soft exoskeleton, the PneuGlove, with embedded bend sensors to provide real-time measurement of digit flexion. Pneumatic resistance to flexion can be applied to each digit independently, along with extension assistance, through air chambers running through the glove. The FES is intended to assist finger flexion by activating extrinsic finger flexor muscles. A high-density 2×8 stimulation electrode grid will be placed over the median and ulnar nerves at the medial side of the upper arm. The stimulator can deliver electrical stimulation to any pair of electrodes. At the beginning of each session, the investigators will identify the electrode pairs which best produce flexion of each digit with minimal discomfort.

  • Occupational Therapy (OT)Behavioural

    Traditional occupational therapy training sessions.

Study groups in NCT05621980
Study groupRoleWhat they receive
Functional electrical stimulation (FES) + AVK groupExperimentalThis group will use the AVK system in combination with targeted FES to provide training of independent movement of each digit of the paretic hand. This training has two modes: Key Combination and Song. In the Key Combination mode, the subject will attempt to play the discrete key or key combinations specified on the computer screen to practice difficult movements and combinations. In the Song mode, sequential, rhythmic movements will be practiced as the participant is guided to play a series of keys, specified as falling keys, constituting five-note songs. Key Combination will be employed at the beginning and end of each training session to practice discrete movements that proved troubling during the current or previous session. Most of the session will be spent in the Song mode to emphasize the transitions from one movement to the next. In both modes the AVK system will trigger FES for the finger matching the desired key and signal the PneuGlove to resist movement of other digits.
Receives: Behavioral: Actuated Virtual Keyboard (AVK) system
OT GroupActive comparatorAn occupational therapist will provide therapy of matching duration to the OT subject group. This will consist of 10 minutes of stretching of the finger muscles, particularly of the extrinsic finger flexors. This stretching will be followed by two 20-minute sessions of therapy focused on active task practice, object manipulation, and individuated movement of the digits. The Canadian Occupational Performance Measure (COPM) will be administered to identify goals that incorporate dexterous use of the paretic hand. Part of each training session will be used to practice these tasks, while the remainder will be used to practice component skills. Active practice will be followed by a final 10 minutes of stretching of muscles of the digits.
Receives: Behavioral: Occupational Therapy (OT)

What is being measured

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

  1. Change of Jebsen-Taylor Hand Function Test (JTHFT)

    A standardized and objective measure of fine and gross motor hand function using simulated activities of daily living.

    Measured: Change of value from before the intervention to immediately after the intervention.

Secondary outcomes (5)

  1. Change of Lateral pinch strength

    Force produced when the thumb pinches against the radial side of the index finger as if holding a key.

    Measured: Change of value from before the intervention to immediately after the intervention.

  2. Change of 3-point pinch strength

    Force produced when thumb pinches against the tips of the index and middle fingers.

    Measured: Change of value from before the intervention to immediately after the intervention.

  3. Change of Touch sensitivity

    Touch sensitivity will be measured with von Frey hairs (Aesthesio®).

    Measured: Change of value from before the intervention to immediately after the intervention.

  4. Change of Box and Blocks Test (BBT)

    A quick, simple and inexpensive test to measures unilateral gross manual dexterity.

    Measured: Change of value from before the intervention to immediately after the intervention.

  5. Change of 9-Hole Peg Test (9PHT)

    A standardized, quantitative assessment used to measure finger dexterity.

    Measured: Change of value from before the intervention to immediately after the intervention.

Timeline

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

  1. First posted18 Nov 2022
  2. Study start5 Sep 2023
  3. Primary completion1 Jul 2025
  4. Study completion31 Jul 2025

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05621980
Sponsor's protocol ID
23989
Other IDs
22-2459, 1R21HD105874-01
Status last verified
Aug 2026
First submitted
11 Oct 2022
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: In accordance with the specifications and limitations outlined by the Institutional Review Boards at North Carolina State University and the University of North Carolina at Chapel Hill, behavioral and performance data will be made available to other investigators upon request.

Publications

  • Connelly L, Jia Y, Toro ML, Stoykov ME, Kenyon RV, Kamper DG. A pneumatic glove and immersive virtual reality environment for hand rehabilitative training after stroke. IEEE Trans Neural Syst Rehabil Eng. 2010 Oct;18(5):551-9. doi: 10.1109/TNSRE.2010.2047588. Epub 2010 Apr 8.

    PubMed 20378482

  • Thielbar KO, Lord TJ, Fischer HC, Lazzaro EC, Barth KC, Stoykov ME, Triandafilou KM, Kamper DG. Training finger individuation with a mechatronic-virtual reality system leads to improved fine motor control post-stroke. J Neuroeng Rehabil. 2014 Dec 26;11:171. doi: 10.1186/1743-0003-11-171.

    PubMed 25542201

  • Shin H, Hu X. Flexibility of Finger Activation Patterns Elicited through Non-invasive Multi-Electrode Nerve Stimulation. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:1428-1431. doi: 10.1109/EMBC.2018.8512479.

    PubMed 30440660

Questions about this trial

What is this clinical trial studying?

A study testing Actuated Virtual Keyboard (AVK) system and Occupational Therapy (OT) in people with Stroke, run by North Carolina State University 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 4 inclusion and 3 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 Aug 2026. 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 of Jebsen-Taylor Hand Function Test (JTHFT) (time frame: Change of value from before the intervention to immediately after the 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 NCT05621980, which also lists 3 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 Aug 2026.

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