An interventional study of Actuated Virtual Keyboard (AVK) system and Occupational Therapy (OT) in Stroke, sponsored by North Carolina State University. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by North Carolina State University · Not applicable, Interventional, and Treatment
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 10 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
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Exclusion Criteria:
This 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.
Behavioral: Actuated Virtual Keyboard (AVK) system
An 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.
Behavioral: Occupational Therapy (OT)
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.
Traditional occupational therapy training sessions.
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.
Time frame: Change of value from before the intervention to immediately after the intervention.
Change of Lateral pinch strength
Force produced when the thumb pinches against the radial side of the index finger as if holding a key.
Time frame: Change of value from before the intervention to immediately after the intervention.
Change of 3-point pinch strength
Force produced when thumb pinches against the tips of the index and middle fingers.
Time frame: Change of value from before the intervention to immediately after the intervention.
Change of Touch sensitivity
Touch sensitivity will be measured with von Frey hairs (Aesthesio®).
Time frame: Change of value from before the intervention to immediately after the intervention.
Change of Box and Blocks Test (BBT)
A quick, simple and inexpensive test to measures unilateral gross manual dexterity.
Time frame: Change of value from before the intervention to immediately after the intervention.
Change of 9-Hole Peg Test (9PHT)
A standardized, quantitative assessment used to measure finger dexterity.
Time frame: Change of value from before the intervention to immediately after the intervention.
Plan to share: 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.
Supporting information: Study protocol, Sap
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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