Finger Movement Training After Stroke

Stroke Clinical Trial

Official title:

A Multimodal Intervention to Improve Manual Dexterity in Subacute Stroke Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05621980
• Other study ID #: 23989
• Secondary ID: 22-24591R21HD105
• Status: Recruiting
• Phase: N/A
• Start date: September 5, 2023
• Est. completion date: August 2026

Study information

• Verified date: November 2023
• Source: North Carolina State University
• Contact: Derek G Kamper, PhD
• Phone: 7735201233
• Email: dgkamper[@]ncsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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 (2-9 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: August 2026
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• A single, unilateral stroke 2-9 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Actuated Virtual Keyboard (AVK) system
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)
Traditional occupational therapy training sessions.

Locations

Country	Name	City	State
United States	Hand Rehabilitation Lab	Raleigh	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
North Carolina State University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change of value from before the intervention to immediately after the intervention.
Secondary	Change of Lateral pinch strength	Force produced when the thumb pinches against the radial side of the index finger as if holding a key.	Change of value from before the intervention to immediately after the intervention.
Secondary	Change of 3-point pinch strength	Force produced when thumb pinches against the tips of the index and middle fingers.	Change of value from before the intervention to immediately after the intervention.
Secondary	Change of Touch sensitivity	Touch sensitivity will be measured with von Frey hairs (Aesthesio®).	Change of value from before the intervention to immediately after the intervention.
Secondary	Change of Box and Blocks Test (BBT)	A quick, simple and inexpensive test to measures unilateral gross manual dexterity.	Change of value from before the intervention to immediately after the intervention.
Secondary	Change of 9-Hole Peg Test (9PHT)	A standardized, quantitative assessment used to measure finger dexterity.	Change of value from before the intervention to immediately after the intervention.