NCT04900896

Outcome Measures Study on an Adult Myoelectric Elbow-Wrist-Hand Orthosis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 59 (actual)
• Sponsor: Myomo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the therapeutic and functional gains of a myoelectric elbow-wrist-hand orthosis for adult individuals with upper limb impairments using repeated measures studies that combines both gross motion and quantitative function outcome measures.

Detailed description

The objective of this study is to evaluate the therapeutic and functional gains of a myoelectric elbow-wrist-hand orthosis for adult individuals with upper limb impairments using repeated measures studies that combines both gross motion and quantitative function outcome measures. The primary outcomes of this study will collect data on the participants' therapeutic and functional outcome measures when using the MyoPro over time in their home. Baseline data without the device will be collected prior to receiving the MyoPro. Data with and without the device will then be collected at 2-weeks post fitting and then at 1-month intervals thereafter for 12 months. These outcome measures will enable an understanding of the participants' functional gains with and without the MyoPro and over time with the MyoPro.

Conditions

• Stroke
• Brachial Plexus Injury
• Spinal Cord Injuries
• Neurological Disease

Interventions

Type	Name	Description
DEVICE	Myoelectric Elbow-Wrist-Hand Orthosis	An arm orthosis that uses myoelectric signals to control the level of mechanical assistance provided to a user's elbow and hand in order to overcome upper limb weakness or paralysis and achieve functional tasks.

Timeline

• Start date: 2021-05-11
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2021-05-25
• Last updated: 2023-05-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study