Rehabilitation Device for Hand Mirror Therapy

NCT06296628 | Completed FDA Device

• 2 other identifiers: 2000037049000
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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 admission and discharge up to 4 weeks

Study Arms (2)

Conventional Therapy Group

ACTIVE COMPARATOR

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

Behavioral: Mirror Therapy

Miraπ Group

EXPERIMENTAL

Participants in this group will train with the Miraπ device.

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 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.

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)
• Vulnerable populations

Sponsors & Collaborators

• Yale University: lead
• Management Center Innsbruck (MCI), Austria: collaborator
• Yale School of Engineering Center for Engineering Innovation and Design: collaborator

Study Sites (1)

Yale New Haven Health Inpatient Rehabilitation Unit, Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Officials

• Rummana Aslam, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Participants are patients admitted to the acute inpatient rehabilitation unit for rehabilitation of the hand and fingers who have one paralyzed hand without pronounced spasticity.

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 6, 2024
• Study Start: April 4, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)