NCT04775693

Robotic Exoskeleton Gait Training During Acute Stroke Rehabilitation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Kessler Foundation · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of this RCT is to explore the clinical, functional and neurophysiological effectiveness of RE-assisted (Robotic Exoskeleton) early intervention gait therapy in stroke patients during inpatient and outpatient stroke rehabilitation as compared to traditional gait training in three groups: 1) RE; 2) RE-Standard of Care (SOC) and 3) SOC. We will evaluate the short and long-term effects on functional mobility, clinical, neurophysiological, community participation and quality of life.

Conditions

• Stroke, Acute

Interventions

Type	Name	Description
DEVICE	RE (Robotic Exoskeleton)	Participants will continue to receive their prescribed standard of care physical therapy/gait training. They will also utilize the robotic exoskeleton twice a week during their inpatient stay and 3 times a week for 5 weeks as an outpatient (for outpatient, only if in the RE group). The Robotic Exoskeleton is a device that will be strapped to the chest and legs and worn over the shoulders like a backpack that will assist in walking. It uses sensors and participant motion to move. A licensed physical therapist will be assisting participants as they use the device.
OTHER	SOC (standard of care)	Traditional physical therapist driven gait training.

Timeline

• Start date: 2017-05-12
• Primary completion: 2021-12-01
• Completion: 2022-12-01
• First posted: 2021-03-01
• Last updated: 2021-03-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study