N/A N=20 Randomized Triple-blind Treatment

Discrete Versus Rhythmic Gait Training

Stroke · Cerebral Vascular Disorders

Bottom Line

View on ClinicalTrials.gov: NCT02650440 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2017

Primary outcome: Primary: Functional Ambulation Scale (FAC) — 1; 0 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Novel Protocol (Procedure); Standard Protocol (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Thais Amanda Rodrigues
Primary completion: Mar 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Functional Ambulation Scale (FAC)	1; 0	—
SECONDARY Six-minute Walking Test (6MWT)	25.4; 7.6	—
SECONDARY Time Up and Go (TUG)	-42.1; -11.3	—
SECONDARY Ten-meters Walking Test (10MWT)	-52.8; -20.3	—
SECONDARY Lower Limbs Fugl-Meyer	2.3; -1.1	—
SECONDARY Berg Scale	11.1; 6.0	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02650440). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.