Clinical evaluation of the bionic glove.

Area of Science:

• Biomedical Engineering
• Rehabilitation Technology
• Neuroscience

Background:

• Spinal cord injury (SCI) often results in paralysis, significantly impacting hand function and independence.
• Functional electrical stimulation (FES) presents a promising avenue for restoring motor capabilities in individuals with SCI.
• The Bionic Glove is a novel FES prototype designed to address the functional deficits of the paralyzed hand.

Purpose of the Study:

• To clinically evaluate the efficacy of the Bionic Glove in improving hand function for individuals with spinal cord injury.
• To assess the impact of the Bionic Glove on grasp power, range of motion, and task performance.
• To determine the patient characteristics that predict successful outcomes with the Bionic Glove.

Main Methods:

• A multicenter clinical trial involving twelve participants with C5-C7 spinal cord injury.
• Participants had used the Bionic Glove for at least six months.
• Standardized assessments included the Upper Extremity Function Test, Functional Independence Measure (FIM), and Quadriplegia Index of Function (QIF).

Main Results:

• Daily use of the Bionic Glove led to significant increases in grasp power and range of movement.
• Active force generated by the Bionic Glove surpassed passive tenodesis forces observed in other studies.
• Most manual tasks showed significant improvement in completion time and perceived difficulty.

Conclusions:

• The Bionic Glove demonstrates significant potential to enhance independence in individuals with C5-C7 spinal cord injury.
• Optimal outcomes are associated with initial Functional Independence Measure and Quadriplegia Index of Function scores between 20% and 50% of maximum values.
• While effective for many tasks, some users with retained dexterity preferred not to use the device for manipulating small objects.