Comparing Mirror Therapy Rehabilitation Device to Conventional Mirror Therapy

NCT ID: NCT06842888

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2025-08-19

Brief Summary

This is a randomized controlled trial which will compare conventional mirror therapy with mirror therapy using the Miraπ device which physically moves a patient's affected limb.

This study will use two parallel groups: (1) receiving conventional mirror therapy as a part of the standard of care as conducted by the participant's clinical care team and (2) receiving mirror therapy with the Miraπ device as conducted by study personnel with the oversight of the participant's clinical care team.

Conditions

Stroke; Pain; Impaired Motor Function

Study Design

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

Study Groups

Conventional Therapy Group

Participants in this group with train using Mirror Therapy (MT), the current standard of care, performing it on the affected arm for 15 minutes daily, 3 days per week until their discharge from clinic (approximately 2-3 weeks).

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, performing it on the affected arm for 15 minutes daily, 3 days per week until their discharge from clinic (approximately 2-3 weeks).

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 need mirror therapy because of their health condition.
• Participants' rehabilitation physician determined that mirror therapy would be appropriate for standard of care.
• 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)
• Minors
• Vulnerable populations

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

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Necolle Morgado-Vega

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Rehabilitation and Wellness Center at the Milford Campus of Bridgeport Hospital

Milford, Connecticut, United States

Countries

United States

Other Identifiers

2000039425

Identifier Type: -

Identifier Source: org_study_id