N/A N=54 Randomized Double-blind Treatment

A Novel Mechanics-based Intervention to Improve Post-stroke Stability

Stroke

Bottom Line

View on ClinicalTrials.gov: NCT02964039 ↗

Enrolled (actual)

Serious AEs

1.8%

Results posted

Jul 2021

Primary outcome: Primary: Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline) — -0.02; 0.12; -0.04; 0.05 Correlation coefficient — p=0.047

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Error reduction (Behavioral); Error augmentation (Behavioral); Activity matched control (Behavioral)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline)	-0.02; 0.12; -0.04; 0.05; 0.11; -0.02	0.047 sig
SECONDARY Functional Gait Assessment (Change From Baseline)	0.1; 1.5; 1.6; 0.8; 1.9; 2.5	0.16
SECONDARY Activities-specific Balance Confidence Scale (Change From Baseline)	2.2; -0.6; 3.7; 2.5; -1.2; 4.1	0.64
SECONDARY 10-meter Walk Test (Change From Baseline)	0.01; 0.03; 0.03; 0.02; 0.04; 0.04	0.92
SECONDARY Fall Incidence	0.50; 0.29; 0.62	>=0.22
SECONDARY Fear of Falling	4; 5; 4	0.99

Summary

The purpose of this study is to determine whether a novel treadmill training intervention can improve the gait stabilization strategy used by individuals who have experienced a stroke.

Eligibility Criteria

Inclusion Criteria

At least 21 years old
Experience of a stroke 6 months prior to participation
Preferred overground gait speed of at least 0.2 m/s
Ability to walk at self-selected speed for 3 minutes without a cane or walker
Provision of informed consent.

Exclusion Criteria

Resting heart rate above 110 beats/min
Resting blood pressure higher than 200/110 mm Hg
History of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
Preexisting neurological disorders or dementia
History of major head trauma
Legal blindness or severe visual impairment
Life expectancy <1 yr; 8)
History of deep vein thrombosis or pulmonary embolism within 6 months
Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
Orthopedic injuries or conditions (e.g. joint replacements) in the lower extremities with the potential to alter the gait pattern.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02964039). 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.