Pilot Trial of Robotic Hand Therapy After Stroke

Robotic-Assisted Hand Therapy for Neurorehabilitation in Adults With Hand Sensorimotor Impairments Following a Stroke: A Pilot Randomized Controlled Trial

This pilot study will test whether the GRIP program-a soft robotic glove with virtual-reality training-can improve hand and arm function in adults undergoing inpatient rehabilitation after a recent stroke. About 20 participants will be randomly assigned to either the GRIP program or action-observation therapy with education, in addition to usual care. The study will assess motor improvement, safety, and acceptability over approximately six weeks.

The goal of this pilot clinical trial is to determine whether the Glove for Rehabilitation and Interactive Practice (GRIP) program can help improve hand and arm movement in adults who have difficulty using their hand after a recent stroke. The GRIP program uses a soft robotic glove and a virtual reality training platform. It is added to the usual rehabilitation care that participants already receive.

The main questions this study aims to answer are:

• Does the GRIP program help improve hand and arm movement?
• Is the GRIP program safe?
• Do participants find the GRIP program acceptable, comfortable, and engaging? (qualitatively).

Researchers will compare the Glove for Rehabilitation and Interactive Practice (GRIP) program with action-observation therapy and education. Action-observation therapy means watching videos of hand movements and then practicing the same movements. Both groups will also receive their usual rehabilitation care. This study will include about 20 adults who are in an inpatient rehabilitation program after a stroke and who have difficulty using their hand.

Inclusion Criteria:

• First unilateral stroke (<6-month post-stroke at enrollment)
• ≥18 years old
• Hand sensorimotor impairments
• Able to understand and follow a two-step instruction
• Admitted to the rehabilitation center and participating in the stroke program

Exclusion Criteria:

• Severe spasticity (score ≥3 on the Modified Ashworth Scale)
• Unilateral spatial neglect
• Moderate to severe hand pain
• Significant motor impairment of the fingers (active finger flexion/extension less than 10°)
• Any medical condition that may interfere with participation