Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06296628
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-28
Brief Title:
Rehabilitation Device for Hand Mirror Therapy
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Comparative Study on Mirror Therapy With a Rehabilitation Device for Training of Affected Fingers
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 000 | OTHER | CTGTY | None |