NCT03104127

Effect of Using a Lower Limb Robotic Device for Patients With Chronic Stroke

Effect of a Community-based, Bionic Leg Rehabilitation Program on Biomechanical, Cardiovascular and Performance Outcomes in Patients With Chronic Stroke

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Winchester · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study will investigate if a lower limb robotic device can be used in a community setting to increase the amount of physical activity that individuals undertake following stroke and consequently improve biomechanical, physiological and health outcomes, in patients with stroke.

Detailed description

Recent advances in technology have helped to develop robotic devices to aid gait training in order to develop more normal movement patterns, strengthen the quadriceps and improve quality of gait. Lower limb robotic devices have been shown to increase functional mobility, walking speed, step length, balance and endurance within a clinical setting. The purpose of this study is to see if a lower limb robotic device leg can be used in a community setting to improve biomechanical (gait, balance, lower-limb strength), physiological (vascular health) and performance outcomes (aerobic fitness, strength) in patients with chronic stroke

Conditions

• Gait, Hemiplegic
• Quality of Life
• Vascular Stiffness
• Stroke

Interventions

Type	Name	Description
DEVICE	Alter G Bionic Leg	Participants are randomized to a 10 week, community-based bionic leg programme. Participants must use the leg for a minimum of 1 hour per day and continue to have active physical therapy sessions.
OTHER	Normal therapy (physiotherapy)	Participants are randomized to a normal therapy (physiotherapy) only program. Participants are also advised to undertake 1 hour a day of physical activity and have active physical therapy (physiotherapy) sessions.

Timeline

• Start date: 2017-04-24
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2017-04-07
• Last updated: 2020-01-18

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study