Clinical trial NCT02650440: Discrete Versus Rhythmic Gait Training
Official title: Robot-assisted Locomotor Training After Severe Stroke: Discrete Versus Rhythmic Movement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Cerebral Vascular Disorders
Keywords: robotics
locomotion
gait
walking
rehabilitation
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-01-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;
* Unconsolidated fractures, pressure sores;
* Other neurological diseases.

Primary outcomes:
measure: Functional Ambulation Scale (FAC)
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Six-minute Walking Test (6MWT)
timeFrame: Baseline and 6 weeks
measure: Time Up and Go (TUG)
timeFrame: Baseline and 6 weeks
measure: Ten-meters Walking Test (10MWT)
timeFrame: Baseline and 6 weeks
measure: Lower Limbs Fugl-Meyer
timeFrame: Baseline and 6 weeks
measure: Berg Scale
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto de Medicina Física e Reabilitação - Lucy Montoro
Study officials:
affiliation: University of Sao Paulo
name: Daniel G Goroso, Doctor
role: STUDY_CHAIR
affiliation: University of Kentucky
name: Lumy Sawaki, PhD
role: STUDY_CHAIR
References: