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Discrete Versus Rhythmic Gait Training

NCT ID: NCT02650440

Last Updated: 2017-09-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-09-30

Brief Summary

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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

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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.

Conditions

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Stroke Cerebral Vascular Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Novel Protocol

Intervention Type PROCEDURE

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.

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.

Group Type EXPERIMENTAL

Standard Protocol

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thais Amanda Rodrigues

OTHER

Sponsor Role lead

Responsible Party

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Thais Amanda Rodrigues

Physiotherapist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Daniel G Goroso, Doctor

Role: STUDY_CHAIR

University of Sao Paulo

Lumy Sawaki, PhD

Role: STUDY_CHAIR

University of Kentucky

Locations

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Instituto de Medicina Física e Reabilitação - Lucy Montoro

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Robotics in Stroke

Identifier Type: -

Identifier Source: org_study_id