Clinical trial NCT03104127: Effect of Using a Lower Limb Robotic Device for Patients With Chronic Stroke
Official title: Effect of a Community-based, Bionic Leg Rehabilitation Program on Biomechanical, Cardiovascular and Performance Outcomes in Patients With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gait, Hemiplegic
Quality of Life
Vascular Stiffness
Stroke
Keywords: Lower-limb robotic device
Gait
Balance
Pressure
Chronic stroke
Blood pressure
Blood velocity
Aerobic fitness
Strength
Lead sponsor: University of Winchester
Sponsor class: OTHER
Collaborators: name: Hobbs Rehabilitation
name: AlterG
name: University of Gloucestershire
name: University of Chester
name: University of Southampton
name: University of North Carolina, Chapel Hill
First posted: 2017-04-07
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline Gait analysis at 10-weeks post-intervention
timeFrame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each gait analysis assessment will take 30 minutes
measure: Change from baseline Gait analysis at 10-weeks post-intervention
timeFrame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each gait analysis assessment will take 30 minutes
measure: Change from baseline Gait analysis at 10-weeks post-intervention
timeFrame: aseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each gait analysis assessment will take 30 minutes
Secondary outcomes:
measure: Timed-up-and-go
timeFrame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. The timed-up-and-go assessment will take 10 minutes
measure: Ashworth scale
timeFrame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 10 minutes
measure: Body mass
timeFrame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 5 minutes
measure: Central and peripheral blood pressures
timeFrame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 5 minutes following 20 minutes supine rest.
measure: Arterial stiffness and blood velocity of the carotid artery
timeFrame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 5 minutes following 20 minutes supine rest.
measure: Physical fitness
timeFrame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 6 minutes.
measure: Strength
timeFrame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 15 minutes.
measure: 7-day physical activity
timeFrame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up.
measure: Postural Sway
timeFrame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each postural sway analysis assessment will take 20 minutes
measure: Manual Muscle Test
timeFrame: Baseline, 10-week post-intervention, 3 month follow-up, 12 month follow-up. Each assessment will take 5 minutes
Other outcomes:
measure: Dynamic gait index
timeFrame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up
measure: Berg Balance
timeFrame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up
measure: Balance Confidence Scale
timeFrame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up
measure: Walking Ability Questionnaire
timeFrame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up
measure: Functional Ambulation Classification
timeFrame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up
measure: International Physical Activity Questionnaire
timeFrame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up
measure: Older Peoples Quality of Life Questionnaire
timeFrame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up
measure: Trail Making
timeFrame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up
Locations:
city: Winchester
country: United Kingdom
facility: University of Winchester
state: Hampshire
Study officials:
affiliation: University of Winchester
name: James Faulkner, PhD
role: PRINCIPAL_INVESTIGATOR
References: