ExoNET for Stroke

Overseen By Courtney Celian

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Must not be taking: Botox

Disqualifiers: Under 18, Bilateral paresis, Spasticity, others

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

Compensation: Varies

Number of Visits: 5

Duration: 2 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a wearable device called ExoNET that helps support the arm's weight. It is aimed at chronic post-stroke patients who have trouble moving their arms. By making it easier to lift and move the arm, the device helps patients practice movements, which can improve their strength and flexibility.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have had a Botox injection in the affected arm within the last 4 months, you cannot participate.

What data supports the effectiveness of the treatment ExoNET for stroke?

Research on similar treatments, like robotic upper-limb movement training and arm weight support devices, shows that these methods can improve motor control and movement smoothness in stroke patients. This suggests that ExoNET, which may involve similar principles, could also be effective in enhancing motor abilities after a stroke. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults who have had a stroke at least 8 months ago and now experience moderate arm weakness (hemiparesis). They should be able to move their shoulder and elbow somewhat but can't join if they have pain or stiffness in the joints, severe muscle tightness, recent Botox treatments in the arm, or problems with understanding that would affect participation.

Inclusion Criteria

I had a stroke more than 8 months ago.

You have a moderate impairment, with a Fugl-Meyer score between 15 and 50.

I have weakness on one side of my body.

Exclusion Criteria

I have moderate muscle stiffness.

I have shoulder pain or stiffness in my arm joint.

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Baseline evaluations including Fugl-Meyer, Wolf Motor Function Test, Action Research Arm Test, and Box and Blocks

1 week

1 visit (in-person)

Treatment

Participants perform reaching, arm elevation, and flexion task exercises wearing the ExoNET device

2 weeks

2 visits (in-person)

Post Evaluation

Post evaluations including Fugl-Meyer, Wolf Motor Function Test, Action Research Arm Test, and Box and Blocks

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 weeks

1 visit (in-person)

Treatment Details

Interventions

• ExoNET

Trial Overview The study is testing ExoNET, a passive robotic device designed to help support the arm during therapy exercises. It aims to see if it's safe and practical for people recovering from a stroke to use this device as part of their rehabilitation.

Participant Groups

Group I: Experimental Group: Gravity Compensation Experimental Treatment 1 Intervention

The participants will be wearing the ExoNet device tuned to gravity support.

Group II: Control Group: No Gravity Compensation Placebo Group 1 Intervention

The participants will be wearing the ExoNet device, but it will not be tuned to gravity support.

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Findings from Research

In a study of 298 patients with moderate stroke and 284 with severe stroke across 5 rehabilitation facilities, occupational therapists and assistants provided the majority of therapy hours, with therapists focusing on advanced activities and assistants handling more basic tasks.

The use of therapy extenders varies by therapy type and patient severity, suggesting that the effectiveness of stroke rehabilitation may depend on how therapy is structured and delivered, highlighting the need for further research on their impact on patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical and occupational therapy in inpatient stroke rehabilitation: the contribution of therapy extenders. Hsieh, CH., Putman, K., Nichols, D., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

A pilot study of rhythm and timing training as a supplement to occupational therapy in stroke rehabilitation. [2016]

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

Physical and occupational therapy in inpatient stroke rehabilitation: the contribution of therapy extenders. [2019]

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

Robotic unilateral and bilateral upper-limb movement training for stroke survivors afflicted by chronic hemiparesis. [2016]

4. Italy pubmed.ncbi.nlm.nih.gov

Arm weight support training improves functional motor outcome and movement smoothness after stroke. [2021]

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

Does trunk, arm, or leg control correlate best with overall function in stroke subjects? [2016]