Rehabilitation Device for Hand Mirror Therapy

NCT ID: NCT06296628

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-04
• Study Completion Date: 2025-04-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Conventional Therapy Group

Participants in this group with train using Mirror Therapy (MT), the current standard of care.

Group Type: ACTIVE_COMPARATOR

Mirror Therapy

Intervention Type: BEHAVIORAL

Current standard of care using MT.

Miraπ Group

Participants in this group will train with the Miraπ device.

Group Type: EXPERIMENTAL

Miraπ

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Mirror Therapy

Current standard of care using MT.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Participants currently accepted and cleared for rehabilitation in the inpatient rehabilitation unit by the rehabilitation medical director.
• Participants with paralysis or motor function problems of only one hand.
• Participants spasticity of the affected hand ( as assessed by by the occupational therapist)
• Participants need mirror therapy because of their health condition.
• Participants are able to memorize easy tasks, and able to follow instructions e.g., moving the healthy fingers.

Exclusion Criteria

• Participants who are not cleared physically or medically to participate in standard acute inpatient rehabilitation therapies by the rehabilitation medical director
• Participants who are not able to memorize easy tasks, e.g., moving the healthy fingers.
• Participants with spasticity of the affected hand ( as assed by the occupational therapist)
• Vulnerable populations

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Management Center Innsbruck (MCI), Austria

UNKNOWN

Sponsor Role: collaborator

Yale School of Engineering Center for Engineering Innovation and Design

UNKNOWN

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rummana Aslam, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale New Haven Health Inpatient Rehabilitation Unit, Bridgeport Hospital

Bridgeport, Connecticut, United States

Countries

United States

Other Identifiers

000

Identifier Type: OTHER

Identifier Source: secondary_id

2000037049

Identifier Type: -

Identifier Source: org_study_id