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

Not yet recruiting

Phase N/A Results N/A

Trial Description

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

Interventions

  • Bionic Leg Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Bionic Leg
    Description: Participants randomised to a group including normal therapy (physiotherapy) and the use of a bionic leg. All participants have previously completed normal NHS therapy.
  • Normal therapy (physiotherapy) Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Bionic Leg
    Description: Participants randomised to a group including normal therapy (physiotherapy) and the use of a bionic leg. All participants have previously completed normal NHS therapy.
    ARM 2: Kind: Experimental
    Label: Normal therapy
    Description: Participants randomised to a group including normal therapy (physiotherapy) only. All participants have previously completed normal NHS therapy.
    ARM 3: Kind: Experimental
    Label: Alter G Bionic Leg
    Description: Participants randomised to a group including normal therapy (physiotherapy) and the use of a Alter G robotic bionic leg. All participants have previously completed normal NHS therapy.
  • Alter G Bionic Leg Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Alter G Bionic Leg
    Description: Participants randomised to a group including normal therapy (physiotherapy) and the use of a Alter G robotic bionic leg. All participants have previously completed normal NHS therapy.

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from baseline Gait analysis at 10-weeks post-intervention Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each gait analysis assessment will take 30 minutes
Secondary Timed-up-and-go Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. The timed-up-and-go assessment will take 10 minutes
Secondary Ashworth scale Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 10 minutes
Secondary Body mass Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 5 minutes
Secondary Central and peripheral blood pressures Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 5 minutes following 20 minutes supine rest.
Secondary Arterial stiffness and blood velocity of the carotid artery Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 5 minutes following 20 minutes supine rest.
Secondary Physical fitness Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 6 minutes.
Secondary Strength Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 15 minutes.
Secondary 7-day physical activity Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up.
Secondary Postural Sway Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each postural sway analysis assessment will take 20 minutes

Sponsors