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

10 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the Mirror Therapy Device for stroke treatment?

Research shows that mirror therapy can help improve movement and function in people who have had a stroke. It involves using a mirror to reflect the movement of the unaffected limb, which can trick the brain into thinking the affected limb is moving, aiding recovery. ^{1 2 3 4 5}

Is mirror therapy safe for humans?

Mirror therapy is generally considered safe for humans, as it involves using a mirror to create a visual illusion that can help with rehabilitation, particularly in stroke patients. There are no reports of harmful effects, but some studies suggest it may cause a shift in weight and leaning towards the unaffected side during therapy. ^{2 3 4 6 7}

How is the Mirror Therapy treatment for stroke different from other treatments?

Mirror Therapy is unique because it uses a mirror to create the illusion that the affected limb is moving, which helps the brain rewire itself to improve movement in the affected limb. This approach is different from other treatments as it focuses on visual feedback and mental imagery to enhance motor recovery. ^{3 4 6 8 9}

Research Team

Rummana Aslam, MD

Principal Investigator

Yale University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Using mirror therapy in the home environment: a case report. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of mirror therapy on motor and sensory recovery in chronic stroke: a randomized controlled trial. [2016]

3. Spain pubmed.ncbi.nlm.nih.gov

[Mirror therapy in hemiplegic patient]. [2016]

4. United States 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. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Mirror therapy for improving motor function after stroke. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Functional plasticity induced by mirror training: the mirror as the element connecting both hands to one hemisphere. [2019]

7. Japan pubmed.ncbi.nlm.nih.gov

Kinematic analysis of head, trunk, and pelvic motion during mirror therapy for stroke patients. [2020]

8. England pubmed.ncbi.nlm.nih.gov

User perspectives on the design and setup of lower limb mirror therapy equipment after stroke: a technical report. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A Mirror Therapy-Based Action Observation Protocol to Improve Motor Learning After Stroke. [2016]