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

University of Winchester

Status

Completed

Conditions

Stroke

Quality of Life

Vascular Stiffness

Gait, Hemiplegic

Treatments

Device: Alter G Bionic Leg

Other: Normal therapy (physiotherapy)

Study type

Interventional

Funder types

Other

Identifiers

NCT03104127

RKE_2017_001

Details and patient eligibility

About

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.

Full 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

Enrollment

40 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with diagnosis of stroke within 3-60 months
Community patients that are medically stable and currently receiving therapeutic input from Hobbs Rehabilitation
Individuals who are able to stand and step with an aid or assistance
Cognitively aware of task demands
Height: 5ft 2-6ft 3 (158-192 cm)
Weight: <25 stone (< 159kg)

Exclusion criteria

Unresolved deep vein thrombosis
Unstable cardiovascular conditions
Open wounds
Active drug resistant infection
Recent fractures of involved limb
Peripheral arterial disease
Incontinence
Severe osteoporosis
Non weight bearing

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 3 patient groups

Alter G Bionic Leg

Experimental group

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.

Treatment:

Other: Normal therapy (physiotherapy)

Device: Alter G Bionic Leg

Normal therapy

Active Comparator group

Description:

Participants randomised to a group including normal therapy (physiotherapy) only. All participants have previously completed normal NHS therapy.

Treatment:

Other: Normal therapy (physiotherapy)

Usual care

No Intervention group

Description: