Comparing Mirror Therapy Rehabilitation Device to Conventional Mirror Therapy

NCT06842888 | Completed

• 1 other identifier: 2000039425
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Change in Jebsen-Taylor Hand Function Test score

  Percentage score, which determines how well a participant can do motor tasks for range of motion, strength, and tasks of activities of daily life. Participants have up to 120 seconds to complete tasks. Lower scores indicate less impairment.

  At baseline and at discharge (approximately 2-3 weeks after baseline)

• McGill Pain Questionnaire (MPQ)

  The MPQ is scored by summing the values of words that best describe a person's pain. The score ranges from 0 (no pain) to 78 (severe pain)

  At baseline and at discharge (approximately 2-3 weeks after baseline)

• Change in Visual Analog Scale (VAS) to assess Pain

  The VAS pain scale is a tool for assessing pain intensity. Participants will be asked to mark a point on a 100 mm horizontal line that represents the intensity of their pain. This line has two endpoints: 0: No pain and 100: Worst possible pain imaginable. The distance from the "0" to the mark is measured in millimeters with the resulting number (0-100) being the VAS pain score

  At baseline and at discharge (approximately 2-3 weeks after baseline)

Study Arms (2)

Conventional Therapy Group

ACTIVE COMPARATOR

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).

Behavioral: Mirror Therapy

Miraπ Group

EXPERIMENTAL

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).

Device: Miraπ

Interventions

Miraπ 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.

Miraπ Group

Mirror Therapy BEHAVIORAL

Current standard of care using MT.

Conventional Therapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Rehabilitation and Wellness Center at the Milford Campus of Bridgeport Hospital

Milford, Connecticut, 06460, United States

Location

MeSH Terms

Conditions

Stroke; Pain

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Officials

• Necolle Morgado-Vega

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Inpatients undergoing inpatient rehabilitation in the IRU (inpatient rehabilitation unit) at the Yale New Haven Hospital Rehabilitation and Wellness Center

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 24, 2025
• Study Start: March 31, 2025
• Primary Completion: August 19, 2025
• Study Completion: August 19, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)