Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05621980

Finger Movement Training After Stroke

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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)

Treatment and study plan

Actuated Virtual Keyboard (AVK) system

Behavioral

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)

Behavioral

Traditional occupational therapy training sessions.

Primary outcomes

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

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

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

Secondary outcomes

  1. Change of Lateral pinch strength

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

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

  2. Change of 3-point pinch strength

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

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

  3. Change of Touch sensitivity

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

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

  4. Change of Box and Blocks Test (BBT)

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

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

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

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

    A standardized, quantitative assessment used to measure finger dexterity.

Study contacts

Contact information is provided by the study sponsor or research team.

Derek G Kamper, PhD

CONTACT

[email protected]

7735201233

Mohammad Ghassemi, PhD

CONTACT

[email protected]

3125365014

Sponsors and collaborators

Lead sponsor

North Carolina State University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

A Multimodal Intervention to Improve Manual Dexterity in Subacute Stroke Survivors

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Nov 18, 2022
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.