NCT03499210

Safety Evaluation of the ReWalk ReStore Device in Subjects With Mobility Impairments Due to Stroke

A Multi-site, Interventional, Non-comparative, Single-arm Trial to Evaluate the Safety of the ReWalk ReStore Device in Subjects With Mobility Impairments Due to Ischemic or Hemorrhagic Stroke

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: ReWalk Robotics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multi-site, interventional, non-comparative, single-arm trial to evaluate the safety of the ReWalk ReStore device in subjects with hemiplegia/hemiparesis due to ischemic or hemorrhagic stroke.

Conditions

• Stroke
• Stroke, Acute
• Stroke Hemorrhagic
• Hemiparesis
• Hemiplegia
• Cerebrovascular Accident

Interventions

Type	Name	Description
DEVICE	ReWalk ReStore device	The ReWalk ReStore device is intended to be used to perform ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia/hemiparesis due to stroke.

Timeline

• Start date: 2018-03-29
• Primary completion: 2018-11-30
• Completion: 2018-11-30
• First posted: 2018-04-17
• Last updated: 2018-11-07

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study