Robot-assisted Locomotor Training After Severe Stroke: Discrete Versus Rhythmic Movement
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Thais Amanda Rodrigues
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Functional Ambulation Scale (FAC)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The objective of this study is to compare the effects of novel versus standard locomotor training using a robotic gait orthosis (LT-RGO) after stroke. The hypothesis is that the novel LT-RGO protocol, by establishing a progressive decrease in gait velocity and guidance force, may facilitate greater motor recovery compared to the use of a standard protocol.
Detailed Description
Standard (rhythmic) robot-assisted locomotor training on a bodyweight-supported treadmill (LT-BWST) used progressively increased speed each week. Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed. The novel approach of slowing down the treadmill reduced momentum. If speed had been increased (standard approach), momentum would have increased (momentum = mass \* velocity); and the resulting, passive propulsion of momentum would have diminished the role of cortical skills needed to plan, initiate, and overtly control gait. In sum, the novel protocol used a slower-than-standard treadmill speed in order to provide a window of time sufficient for the corticomotor system to process information, learn, and adjust its response to internal and external feedback (eg, proprioceptive input; therapist input) during robot-assisted LT-BWST.
Investigators
Thais Amanda Rodrigues
Physiotherapist
University of Sao Paulo
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of stroke and image with hemiparesis left or right;
- •No more that one ischemic or hemorrhagic stroke episode;
- •06 months post-stroke;
- •Verified clinical stability on medical evaluation;
- •Spasticity level I or II in the Ashworth scale;
- •Score 1-2 in the Functional Ambulation Scale (FAC);
- •Signed informed consent.
Exclusion Criteria
- •Dependence to perform activities of daily living before the stroke;
- •Lack of clinical indications for exercises (such as cardiopulmonary instability and uncontrolled diabetes);
- •Severe cognitive impairment;
- •Serious psychiatric change that needs psychiatric care;
- •Severe osteoporosis;
- •Severe spasticity of the lower limbs, deformities or fixed contractures that prevent the achievement of movements;
- •Lack of resistance or disabling fatigue;
- •Body weight greater than 150 kg;
- •Unstable angina or other untreated heart disease;
- •Chronic obstructive pulmonary disease;
Outcomes
Primary Outcomes
Functional Ambulation Scale (FAC)
Time Frame: Baseline and 6 weeks
The Functional Ambulation Scale (FAC) assesses an individual's independence during gait and follows a six-level scale: 0 - Patient can not walk or ask for help from two or more people; 1 - Patient requires continuous support from a person who assists with weight and balance; 2 - Patient needs continuous or intermittent support from a person to help with balance and coordination; 3 - Patient required for a person without physical contact; 4 - Patient can walk independently on the floor, but requires help on stairs and ramps; 5 - Patient can walk independently. This study compared the gait independence by the FAC between the two Arms, after intervention as compared to baseline.
Secondary Outcomes
- Time Up and Go (TUG)(Baseline and 6 weeks)
- Ten-meters Walking Test (10MWT)(Baseline and 6 weeks)
- Six-minute Walking Test (6MWT)(Baseline and 6 weeks)
- Lower Limbs Fugl-Meyer(Baseline and 6 weeks)
- Berg Scale(Baseline and 6 weeks)