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Discrete Versus Rhythmic Gait Training

T

Thais Amanda Rodrigues

Status

Completed

Conditions

Stroke
Cerebral Vascular Disorders

Treatments

Procedure: Novel Protocol
Procedure: Standard Protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT02650440
Robotics in Stroke

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

20 participants in 2 patient groups

Novel Protocol
Experimental group
Description:
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.
Treatment:
Procedure: Novel Protocol
Standard Protocol
Experimental group
Description:
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.
Treatment:
Procedure: Standard Protocol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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