Discrete Versus Rhythmic Gait Training

Robot-assisted Locomotor Training After Severe Stroke: Discrete Versus Rhythmic Movement

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02650440

Enrollment

Registered

2016-01-08

Start date

2014-11-30

Completion date

2016-09-30

Last updated

2017-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Cerebral Vascular Disorders

Keywords

robotics, locomotion, gait, walking, rehabilitation

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.

Interventions

PROCEDURENovel Protocol

All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject.

PROCEDUREStandard Protocol

All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Standard (rhythmic) robot-assisted LT-BWST used progressively increased speed each week. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Six-minute Walking Test (6MWT)	Baseline and 6 weeks	Change in distance of the gait applied test after intervention as compared to baseline
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
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.

Countries

Brazil

Participant flow

Participants by arm

Arm	Count
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. Novel Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject.	10
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. Standard Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Standard (rhythmic) robot-assisted LT-BWST used progressively increased speed each week. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject	10
Total	20

Baseline characteristics

Characteristic	Standard Protocol	Novel Protocol	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	3 Participants	1 Participants	4 Participants
Age, Categorical Between 18 and 65 years	5 Participants	9 Participants	14 Participants
Age, Continuous	59.3 years STANDARD_DEVIATION 13.8	50.6 years STANDARD_DEVIATION 14.4	50.6 years STANDARD_DEVIATION 14.3
Region of Enrollment Brazil	8 participants	10 participants	18 participants
Sex: Female, Male Female	4 Participants	6 Participants	10 Participants
Sex: Female, Male Male	4 Participants	4 Participants	8 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 10	0 / 8
other Total, other adverse events	0 / 10	0 / 8
serious Total, serious adverse events	0 / 10	0 / 8

Outcome results

Primary

Functional Ambulation Scale (FAC)

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.