Rehabilitation Device for Hand Mirror Therapy

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Behavioral: Mirror Therapy; Device: Miraπ

• Registration Number: NCT06296628
• Lead Sponsor: Yale University

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.

Study Timeline

• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-02-28
• Study First Posted: 2024-03-06
• Study Start: 2024-04-04
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Therapy Group	Mirror Therapy	Participants in this group with train using Mirror Therapy (MT), the current standard of care.
Miraπ Group	Miraπ	Participants in this group will train with the Miraπ device.

Primary Outcome Measures

Name	Time	Method
Change in Jebsen-Taylor Hand Function Test score	At admission and discharge up to 4 weeks	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.

Trial Locations

Locations (1)

Yale New Haven Health Inpatient Rehabilitation Unit, Bridgeport Hospital; 🇺🇸 Bridgeport, Connecticut, United States