MyoMo for Spinal Cord Injury

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Must be taking: Baclofen

Disqualifiers: Excessive pain, Spasticity, Pregnancy, 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: Unknown

Duration: 12 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

To evaluate the usefulness of an upper extremity assistive device, called (MyoPro) in improving upper extremity activities in people with incomplete spinal cord injury. The Department of Defense is supporting this study.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. The trial requires that you continue taking all prescribed medication without any dosing changes.

What data supports the effectiveness of the treatment MyoPro for spinal cord injury?

Research shows that using the MyoPro device, a myoelectric-powered wearable orthosis, can improve hand and elbow movement and muscle activation in people with spinal cord injuries. Studies found that after training with the device, participants experienced better handgrip strength and range of motion, which helped them perform daily activities more independently. ^{1 2 3 4 5}

Is the MyoMo device safe for use in humans?

The MyoMo device, including its variations like MyoPro, has been generally considered safe for use in humans, but there are some risks. For example, in one study, symptomatic hypotension (low blood pressure causing symptoms) was the most common adverse event during exoskeleton-assisted walking. Additionally, there have been reports of bone fractures during exoskeleton use, suggesting the need for extra safety training and precautions. ^{1 2 6 7 8}

How does the MyoPro treatment differ from other treatments for spinal cord injury?

The MyoPro treatment is unique because it is a wearable device that uses weak muscle signals to assist arm and hand movement, helping people with spinal cord injuries improve their ability to perform daily activities. Unlike other treatments, it focuses on enhancing the user's existing muscle activity to restore function, rather than relying solely on external support or stimulation. ^{1 2 5 9 10}

Eligibility Criteria

This trial is for individuals with incomplete spinal cord injuries who have difficulty using their arms. Participants should be able to follow the study procedures and attend all sessions. Specific criteria may apply, but are not listed here.

Inclusion Criteria

My spinal cord injury is between C1-C8 and is moderate to severe.

Be able to activate certain muscles in the arm and forearm on their own as measured by EMG amplitude, determined by study OT/PT

It has been over a year since my injury.

Exclusion Criteria

Difficulty following multiple step directions

Pregnancy

Excessive spasticity in the elbow or wrist, as determined by study staff

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MyoMo training in-clinic for 6 weeks, followed by continued training in-clinic and at home for another 6 weeks

12 weeks

Multiple visits (in-person and at home)

Control

Participants receive conventional therapy in-clinic and use their prescribed static brace for 6 weeks, followed by continued therapy in-clinic and at home for another 6 weeks

12 weeks

Multiple visits (in-person and at home)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measurements of brain signals, CUE-Q, GRASSP, range of motion, muscle strength, and spasticity

36 weeks

Treatment Details

Interventions

• MyoPro

Trial Overview The study is testing a powered wearable orthotic device called MyoPro, comparing its effectiveness in improving arm function and daily activities against conventional therapy methods supported by the Department of Defense.

Participant Groups

Group I: MyoPro Experimental Treatment 1 Intervention

Receiving MyoMo training in-clinic for 6 weeks, and continuing MyoMo training in-clinic and at home for another 6 weeks.

Group II: Control Active Control 1 Intervention

Receiving conventional therapy in-clinic and using their prescribed static brace (or others) for 6 weeks, and continuing the conventional therapy in-clinic and home using their prescribed static brace (or others) at home for 6 weeks.

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

Approved in United States as MyoPro for:

• Severe chronic arm motor deficits due to stroke
• Neuromuscular conditions such as spinal cord injury, brachial plexus injury, traumatic brain injury

Approved in European Union as MyoPro for:

• Severe chronic arm motor deficits due to stroke
• Neuromuscular conditions such as spinal cord injury, brachial plexus injury, traumatic brain injury

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Findings from Research

The MyoPro™ orthosis significantly improved motor function in individuals with chronic upper limb weakness due to stroke or traumatic brain injury, with a notable increase of 7.5 points on the Fugl-Meyer assessment after 18 therapy sessions.

Participants reported high satisfaction with the MyoPro device, and improvements were observed in multiple measures of arm function, indicating its potential as an effective tool for motor learning-based therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myoelectric Arm Orthosis in Motor Learning-Based Therapy for Chronic Deficits After Stroke and Traumatic Brain Injury. Pundik, S., McCabe, J., Skelly, M., et al.[2022]

A 43-year-old man with subacute incomplete spinal cord injury showed improved upper extremity motor function after 18 sessions of therapy using a myoelectric-powered wearable orthosis (MPWO), enhancing his ability to perform daily activities.

The use of the MPWO led to increased active range of motion in the hand and elbow, suggesting that this device-assisted rehabilitation could significantly benefit individuals with upper extremity weakness following spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor Control Changes after Utilizing Upper Extremity Myoelectric Powered Wearable Orthotics in Persons with Acute SCI. Androwis, GJ., Engler, A., AlRabadi, S., et al.[2023]

A study on individuals with incomplete spinal cord injury (iSCI) showed that using a myoelectric powered wearable orthosis (UE-MPWO) for 6 weeks significantly improved handgrip active range of motion (AROM) and handgrip force.

The combination of in-clinic rehabilitation and at-home use of the UE-MPWO suggests it can effectively enhance upper extremity function, making it a promising rehabilitation tool for those with iSCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper Extremity Functional Improvements in Persons with SCI Resulted from Daily Utilization of Myoelectric Powered Wearable Orthotics. Androwis, GJ., Engler, A., Rana, S., et al.[2022]

A 42-year-old woman with 29.5 years post-traumatic brain injury showed significant improvements in motor function after using a myoelectric orthosis combined with motor learning therapy, indicating the potential efficacy of this novel intervention.

The participant engaged in extensive training with the orthosis, completing over 13,000 repetitions, which suggests that high repetition and long-duration practice can lead to meaningful recovery in motor control even years after injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a myoelectric upper limb orthosis for rehabilitation of the upper limb in traumatic brain injury: A case report. Pundik, S., McCabe, J., Kesner, S., et al.[2023]

The study evaluated a myoelectric-powered wearable orthosis (MPWO) for upper extremity movement assistance in two male participants with chronic incomplete spinal cord injury, showing improvements in handgrip strength and active range of motion after 18 rehabilitation sessions over 6 weeks.

Results indicated that using the MPWO reduced the response time to initiate movements, suggesting that this device could enhance upper extremity function and improve daily living activities for individuals with some residual muscle activation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Rehabilitation Effects of Myoelectric Powered Wearable Orthotics on Improving Upper Extremity Function in Persons with SCI. Androwis, GJ., Engler, A., Rana, S., et al.[2022]

Powered exoskeletons have been shown to enable 76% of patients with spinal cord injury to walk independently after training, with sessions typically lasting 60-120 minutes, three times a week for up to 24 weeks.

The training was safe, with a low incidence of falls (4.4%) and fractures (3.4%), and no serious adverse events reported, indicating that newer exoskeleton designs have improved safety features.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injury: systematic review with meta-analysis. Miller, LE., Zimmermann, AK., Herbert, WG.[2022]

Two cases of bone fractures were reported during the use of powered robotic exoskeletons in patients with spinal cord injury, highlighting the potential risks associated with unexpected technical failures.

Proper alignment of the exoskeleton with the user's body is crucial to minimize fracture risks, and additional safety training is recommended for both patients and instructors to handle emergency situations effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Report: Description of two fractures during the use of a powered exoskeleton. van Herpen, FHM., van Dijsseldonk, RB., Rijken, H., et al.[2023]

A study involving 12 participants with acute/sub-acute spinal cord injuries showed that using powered exoskeletons for locomotor training is generally safe, although symptomatic hypotension was the most common adverse event reported.

The feasibility of using exoskeletons was demonstrated, with 54% protocol compliance and 58% of participants achieving at least minimal assistance during walking sessions, indicating potential for effective rehabilitation in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and feasibility of exoskeleton-assisted walking during acute/sub-acute SCI in an inpatient rehabilitation facility: A single-group preliminary study. Delgado, AD., Escalon, MX., Bryce, TN., et al.[2021]

The OrthoJacket is a novel non-invasive neuro-orthosis designed to restore hand and arm functions in high tetraplegic spinal cord injury patients, aiming to improve their independence in daily activities.

This system combines mechanical stabilization with functional electrical stimulation and flexible fluidic actuators, allowing for both functional restoration and training, while adapting to individual anatomical and neurological needs through advanced sensor systems and user interfaces.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OrthoJacket: an active FES-hybrid orthosis for the paralysed upper extremity. Schill, O., Wiegand, R., Schmitz, B., et al.[2011]

The motor-augmented wrist-driven orthosis (MWDO) enhances grasping ability for individuals with C6-C7 spinal cord injuries by combining both body-powered and motorized actuation, allowing for more flexible and dexterous hand movements.

The MWDO features a control scheme that decouples wrist and finger movements, along with a magnetic latch at the finger joint, improving the ability to perform daily activities like pinching and grasping.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor-Augmented Wrist-Driven Orthosis: Flexible Grasp Assistance for People with Spinal Cord Injury. McPherson, AIW., Patel, VV., Downey, PR., et al.[2020]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Myoelectric Arm Orthosis in Motor Learning-Based Therapy for Chronic Deficits After Stroke and Traumatic Brain Injury. [2022]

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

Motor Control Changes after Utilizing Upper Extremity Myoelectric Powered Wearable Orthotics in Persons with Acute SCI. [2023]

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

Upper Extremity Functional Improvements in Persons with SCI Resulted from Daily Utilization of Myoelectric Powered Wearable Orthotics. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Use of a myoelectric upper limb orthosis for rehabilitation of the upper limb in traumatic brain injury: A case report. [2023]

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

The Rehabilitation Effects of Myoelectric Powered Wearable Orthotics on Improving Upper Extremity Function in Persons with SCI. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injury: systematic review with meta-analysis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Case Report: Description of two fractures during the use of a powered exoskeleton. [2023]

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

Safety and feasibility of exoskeleton-assisted walking during acute/sub-acute SCI in an inpatient rehabilitation facility: A single-group preliminary study. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

OrthoJacket: an active FES-hybrid orthosis for the paralysed upper extremity. [2011]

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

Motor-Augmented Wrist-Driven Orthosis: Flexible Grasp Assistance for People with Spinal Cord Injury. [2020]