Rehabilitation Device for Hand Mirror Therapy

Yale University

Status: Completed

Conditions: Stroke

Treatments: Behavioral: Mirror Therapy; Device: Miraπ

Study type: Interventional

Funder types: Other

Identifiers

NCT06296628

2000037049

000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Conventional Therapy Group

Active Comparator group

Description:

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

Treatment:

Behavioral: Mirror Therapy

Miraπ Group

Experimental group

Description:

Participants in this group will train with the Miraπ device.

Treatment:

Device: Miraπ