NCT06296628

Rehabilitation Device for Hand Mirror Therapy

Comparative Study on Mirror Therapy With a Rehabilitation Device for Training of Affected Fingers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized and open comparative study that uses two parallel groups: a control group training with conventional therapy and another group that trains with the device "Miraπ". The participants are patients with stroke with motor weakness in one hand. Two measurement visits are required. During those visits, different hand function assessments will be carried out to analyze the motor function of the subjects hand. The measurements will be done during their inpatient rehabilitation stay, one at time of admission and the second at discharge, each taking 20 minutes. In the time between the measurement visits, the hand therapy takes place fivemtimes a week.

Detailed description

The investigators hypothesize that the physical MT with Miraπ with physical movement of the affected hand will be generating a better patient outcome than conventional MT. Until now MT is performed in front of a mirror with the help of an occupational therapist, which can prove to be difficult. The affected hand of the patient is not moved during training. For the reasons mentioned, the mirror therapy device MIRAπ was developed. With MIRAπ, no mirror is needed and the affected hand is also physically moved by the device. Therefore, this clinical trial will focus on evaluating the device to see if it works better than conventional MT and therefore creates greater benefits to the patients.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Miraπ	This device has tiny sensors that measure the movement of the healthy fingers and tiny motors that move the affected fingers of the patient. The device is connected to a specially designed finger mechanism that moves the affected fingers of the patient. This opening mechanism is designed in a way that it prevents the fingers from being forced into any hurting position. If the patient moves the healthy fingers during training, also the fingers of the affected hand are moved by the device at the same time. This creates the effect of mirror therapy for the brain as the patient can see both hands moving.
BEHAVIORAL	Mirror Therapy	Current standard of care using MT.

Timeline

• Start date: 2024-04-04
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2024-03-06
• Last updated: 2025-06-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study