Clinical trial NCT06296628: Rehabilitation Device for Hand Mirror Therapy
Official title: Comparative Study on Mirror Therapy With a Rehabilitation Device for Training of Affected Fingers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Management Center Innsbruck (MCI), Austria
name: Yale School of Engineering Center for Engineering Innovation and Design
First posted: 2024-03-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Jebsen-Taylor Hand Function Test score
timeFrame: At admission and discharge up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bridgeport
country: United States
facility: Yale New Haven Health Inpatient Rehabilitation Unit, Bridgeport Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Rummana Aslam, MD
role: PRINCIPAL_INVESTIGATOR
References: