Rehabilitation Device for Hand Mirror Therapy

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06296628
• Other study ID #: 2000037049
• Secondary ID: 000
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: April 2024

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: Rummana Aslam, MD
• Phone: 203-747-5412
• Email: Rummana.aslam[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Mirap
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.

Locations

Country	Name	City	State
United States	Yale New Haven Health Inpatient Rehabilitation Unit, Bridgeport Hospital	Bridgeport	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	Management Center Innsbruck (MCI), Austria, Yale School of Engineering Center for Engineering 26 Innovation and Design

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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