Mirror Therapy Device for Stroke

Overseen By Daniel Wiznia, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Not cleared for rehab, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new mirror therapy device called Miraπ, designed to help stroke patients with hand weakness regain better motor function. It compares the effects of conventional mirror therapy with training using the Miraπ device to determine which is more effective. Participants will have their hand function assessed twice during their stay in an inpatient rehabilitation unit. The trial seeks stroke patients with one weak hand who need mirror therapy and can follow simple instructions. As an unphased trial, it offers patients the opportunity to contribute to innovative research that could enhance rehabilitation techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Miraπ device is safe for stroke patients?

Research shows that mirror therapy is generally safe. This therapy uses a mirror to create a visual trick that aids recovery. Studies indicate that this method is well-tolerated, with no serious side effects reported. Many participants find it effective for improving movement after a stroke. Prospective participants in a trial with the Miraπ device can feel confident in the therapy's strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Miraπ device for stroke rehabilitation because it represents a novel approach to mirror therapy. Unlike conventional mirror therapy, which typically involves simple reflective exercises, the Miraπ device offers an enhanced, potentially more engaging and immersive experience for patients. This innovative technology could lead to improved motor recovery by providing more precise and personalized therapy, making it a promising advancement in stroke rehabilitation.

What evidence suggests that the Miraπ device is effective for stroke rehabilitation?

Research has shown that mirror therapy can greatly help stroke patients improve movement and control. Studies have found that people using mirror therapy perform better in movement tasks. This method is particularly effective for enhancing motor skills and daily activities. Some research also suggests it might help reduce pain for stroke survivors. In this trial, participants will be divided into two groups: one will use the traditional mirror therapy method, while the other will train with the Miraπ device. The Miraπ device aims to enhance the improvements seen with traditional mirror therapy. ^{3 5 6 7 8}

Who Is on the Research Team?

Rummana Aslam, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for stroke patients with motor weakness in one hand. They must be able to participate in therapy five times a week during their inpatient rehabilitation stay and attend two measurement visits.

Inclusion Criteria

I am approved for inpatient rehabilitation by the medical director.

I can remember simple tasks and follow instructions.

My hand is stiff or has muscle spasms, as confirmed by an occupational therapist.

Exclusion Criteria

Vulnerable populations

I struggle to remember simple tasks.

I am not medically cleared for standard inpatient rehab therapies.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive hand therapy five times a week using either conventional Mirror Therapy or the Miraπ device

4 weeks

5 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Miraπ
• Mirror Therapy

Trial Overview

The study compares conventional therapy (control group) with the 'Miraπ' device used for mirror therapy (test group). Patients are randomly assigned to either group, and their hand function is assessed at admission and discharge.

How Is the Trial Designed?

Group I: Miraπ Group Experimental Treatment 1 Intervention

Participants in this group will train with the Miraπ device.

Group II: Conventional Therapy Group Active Control 1 Intervention

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

Mirror Therapy is already approved in European Union, United States for the following indications:

Approved in European Union as Mirror Therapy for:

• Stroke rehabilitation
• Motor weakness in one hand

Approved in United States as Mirror Therapy for:

• Stroke rehabilitation
• Motor weakness in one hand

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Management Center Innsbruck (MCI), Austria

Collaborator

Trials

1

Recruited

10+

Yale School of Engineering Center for Engineering 26 Innovation and Design

Collaborator

Trials

1

Recruited

10+

Yale School of Engineering Center for Engineering Innovation and Design

Collaborator

Trials

1

Recruited

10+

Published Research Related to This Trial

Mirror therapy, when combined with conventional rehabilitation, significantly improves motor function in stroke patients, as shown in seven randomized controlled trials with medium-high methodological quality.

While there are positive results regarding the effect of mirror therapy on hemineglect, the evidence is limited and inconclusive due to the small sample sizes in the studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mirror therapy in hemiplegic patient]. Lisalde-Rodríguez, ME., Garcia-Fernández, JA.[2016]

Mirror therapy (MT) significantly improves lower-limb motor recovery, balance, and gait in subacute and chronic stroke patients, with a notable effect size for motor recovery (SMD 0.59) and gait (SMD 1.13) based on a review of 10 studies.

MT can be effectively implemented as a standalone treatment for 30 minutes a day, 5 days a week for 4 weeks, and may also be combined with electrical stimulation to enhance gait recovery, particularly in patients without severe cognitive disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of mirror therapy on lower limb motor recovery, balance and gait in subacute and chronic stroke: A systematic review. Kundi, MK., Spence, NJ.[2023]

Mirror therapy (MT) significantly improved movement performance and motor control in chronic stroke patients, as evidenced by better scores on the Fugl-Meyer Assessment and faster reaction times compared to control treatment (CT).

While MT enhanced sensory recovery, particularly in temperature sense, it did not lead to significant improvements in daily functioning as measured by the Motor Activity Log and ABILHAND questionnaire.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mirror therapy on motor and sensory recovery in chronic stroke: a randomized controlled trial. Wu, CY., Huang, PC., Chen, YT., et al.[2016]

A co-design approach involving 26 participants, including 16 stroke survivors and 10 physiotherapists, led to the development of a lower limb mirror therapy device tailored to the specific needs of stroke survivors.

Key features identified for the device included the ability to facilitate ankle exercises from an upright sitting position, an adjustable angle for optimal reflection, and a lightweight design for ease of use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User perspectives on the design and setup of lower limb mirror therapy equipment after stroke: a technical report. Bajuaifer, S., Grey, MJ., Hancock, N., et al.[2022]

Mirror therapy (MT) significantly enhances the performance of the untrained hand in stroke patients by promoting neural plasticity, as shown in a study with 26 healthy participants performing fine motor tasks.

fMRI results indicate that MT leads to specific activation changes in brain regions associated with motor control, enhancing functional connectivity between the premotor cortex and the sensorimotor cortex, which may aid in recovery from hand paresis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional plasticity induced by mirror training: the mirror as the element connecting both hands to one hemisphere. Hamzei, F., Läppchen, CH., Glauche, V., et al.[2019]

In a study involving 3 hemiparesis stroke patients and 5 healthy adults, mirror therapy (MT) showed that larger mirror sizes and smaller angles improved kinematic parameters, indicating better movement control during therapy.

Using virtual reality reflection equipment (VRRE) during MT helped patients move closer to the midline and showed a tendency to shift weight towards the affected side, suggesting that VRRE could enhance the effectiveness of MT for stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kinematic analysis of head, trunk, and pelvic motion during mirror therapy for stroke patients. Kim, J., Yi, J., Song, CH.[2020]

Mirror therapy significantly improves motor function and motor impairment in stroke patients, with moderate-quality evidence from 62 studies involving 1982 participants, suggesting it can be an effective adjunct to conventional rehabilitation.

The therapy also shows potential benefits for enhancing activities of daily living and reducing pain, with no reported adverse effects, although the evidence quality is uncertain due to small sample sizes and methodological limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mirror therapy for improving motor function after stroke. Thieme, H., Morkisch, N., Mehrholz, J., et al.[2022]

In a study involving 37 stroke survivors, those who practiced mirror therapy with action observation (AO) showed a significant 18.3% reduction in movement time for reaching tasks, compared to a 9.1% reduction in the control group observing static images.

The results indicate that mirror therapy-based AO is more effective for improving motor learning in the affected arm after a stroke, as evidenced by a statistically significant greater decrease in movement time compared to the control observation group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mirror Therapy-Based Action Observation Protocol to Improve Motor Learning After Stroke. Harmsen, WJ., Bussmann, JB., Selles, RW., et al.[2016]

A self-administered home-based mirror therapy program, practiced for 5 weeks with an average of 39.23 minutes per day, was feasible for a stroke patient and led to improvements in upper extremity function.

The participant showed significant enhancements in all assessed outcome measures, indicating that mirror therapy can effectively aid recovery after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using mirror therapy in the home environment: a case report. Nilsen, DM., DiRusso, T.[2019]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7012218/

Mirror Therapy in Stroke Rehabilitation: Current Perspectives

MT showed definitive motor and sensory improvements although the extent of improvements in sensory impairments and hemineglect is limited. MT ...

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withpower.com

withpower.com/trial/phase-stroke-2-2024-a22f9

Mirror Therapy Device for Stroke · Info for Participants

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clinicaltrials.gov

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Mirror Therapy Efficacy in Upper Limb Rehabilitation Early ...

This study evaluates the effects of mirror therapy on upper-limb motor impairment in stroke patients early after their cerebrovascular accident.

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research.aota.org

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Clinic- and Home-Based Practice of Mirror Therapy Preceding ...

The results showed that the clinic-based sessions led to more improvements in motor and balance, whereas the home-based sessions improved ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0306452218304627

Effect of Mirror Therapy on Recovery of Stroke Survivors

MT may improve motor function and ADL more, as well as significant reduction of pain perception in stroke patients. In addition, MT combined ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6513639/

Mirror therapy for improving motor function after stroke - PMC

Mirror therapy is used to improve motor function after stroke. During mirror therapy, a mirror is placed in the person's midsagittal plane.

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S2001037024000175

Robotic mirror therapy for stroke rehabilitation through ...

Mirror therapy is a standard technique of rehabilitation for recovering motor and vision abilities of stroke patients, especially in the case of asymmetric ...

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nature.com

nature.com/articles/s41598-023-49571-7

A mirror therapy system using virtual reality and an ...

We propose an innovative mirror therapy system that leverages and couples cutting-edge technologies. Virtual reality recreates an immersive and effective ...