Discrete Versus Rhythmic Gait Training

Not Applicable

Completed

Conditions: Cerebral Vascular Disorders
Stroke

Interventions: Procedure: Novel Protocol
Procedure: Standard Protocol

Registration Number: NCT02650440

Lead Sponsor: Thais Amanda Rodrigues

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Novel Protocol	Novel Protocol	Progressive decrease of speed and guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.0 km/h.
Standard Protocol	Standard Protocol	Progressive increase of speed and decrease of guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.9 km/h.

Primary Outcome Measures

Name	Time	Method
Functional Ambulation Scale (FAC)	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 Outcome Measures

Name	Time	Method
Time Up and Go (TUG)	Baseline and 6 weeks	This test assesses the level of mobility of the individual to measure the time spent to get up from a chair, walk a distance of 3 meters, turn around and return. This study compared the change in the time of the gait applied test after intervention as compared to baseline.
Ten-meters Walking Test (10MWT)	Baseline and 6 weeks	Change in the time of the gait applied test after intervention as compared to baseline
Six-minute Walking Test (6MWT)	Baseline and 6 weeks	Change in distance of the gait applied test after intervention as compared to baseline
Lower Limbs Fugl-Meyer	Baseline and 6 weeks	The Fugl Meyer Scale is a cumulative numerical scoring system that is assessed by an individual: range of motion, pain, tenderness, upper and lower extremity motor function and balance, plus coordination and speed of movement, with total 226 points. A three-point ordinal scale is applied to each item: 0 - can not be performed, 1-performed partially and 2-performed completely. For this study it was only an evaluation of motor function of the extremity of lower limbs with a total score of 0 to 34 points. The lower score indicates greater motor impairment. This study compared the change in motor function of lower limbs applied scale after intervention as compared to baseline
Berg Scale	Baseline and 6 weeks	Berg Scale is a functional scale of equilibrium performance, based on 14 common everyday items that evaluate the static and dynamic balance. The maximum scale score is 56 and each scale item has five alternatives ranging from 0 to 4 points. A score below 45 is considered a fall risk. This study comparede the change in the balance control applied scale after intervention as compared to baseline.