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Clinical Trials/NCT06842888
NCT06842888CompletedNot Applicable

Comparing Mirror Therapy Rehabilitation Device to Conventional Mirror Therapy

Yale University2 sites in 1 country24 target enrollmentStarted: March 31, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
24
Locations
2
Primary Endpoint
Change in Jebsen-Taylor Hand Function Test score

Study Overview

Brief Summary

This is a randomized controlled trial which will compare conventional mirror therapy with mirror therapy using the Miraπ device which physically moves a patient's affected limb.

This study will use two parallel groups: (1) receiving conventional mirror therapy as a part of the standard of care as conducted by the participant's clinical care team and (2) receiving mirror therapy with the Miraπ device as conducted by study personnel with the oversight of the participant's clinical care team.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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 need mirror therapy because of their health condition.
  • •Participants' rehabilitation physician determined that mirror therapy would be appropriate for standard of care.
  • •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

Arms & Interventions

Conventional Therapy Group

Active Comparator

Participants in this group with train using Mirror Therapy (MT), the current standard of care, performing it on the affected arm for 15 minutes daily, 3 days per week until their discharge from clinic (approximately 2-3 weeks).

Intervention: Mirror Therapy (Behavioral)

Miraπ Group

Experimental

Participants in this group will train with the Miraπ device, performing it on the affected arm for 15 minutes daily, 3 days per week until their discharge from clinic (approximately 2-3 weeks).

Intervention: Miraπ (Device)

Outcomes

Primary Outcomes

Change in Jebsen-Taylor Hand Function Test score

Time Frame: At baseline and at discharge (approximately 2-3 weeks after baseline)

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.

McGill Pain Questionnaire (MPQ)

Time Frame: At baseline and at discharge (approximately 2-3 weeks after baseline)

The MPQ is scored by summing the values of words that best describe a person's pain. The score ranges from 0 (no pain) to 78 (severe pain)

Change in Visual Analog Scale (VAS) to assess Pain

Time Frame: At baseline and at discharge (approximately 2-3 weeks after baseline)

The VAS pain scale is a tool for assessing pain intensity. Participants will be asked to mark a point on a 100 mm horizontal line that represents the intensity of their pain. This line has two endpoints: 0: No pain and 100: Worst possible pain imaginable. The distance from the "0" to the mark is measured in millimeters with the resulting number (0-100) being the VAS pain score

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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