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NCT02964039

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

Completed NA Results posted Last updated 3 June 2024
What this trial tests

NA trial testing Error reduction in Stroke in 54 participants. Completed in 31 March 2020.

Timeline
1 April 2017
Primary endpoint
31 March 2020
31 March 2020

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment54
Start date1 April 2017
Primary completion31 March 2020
Estimated completion31 March 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

21 and older, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline) Primary · baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks

A custom measure that quantifies the strength of the relationship between body mechanics and foot placement. This measure falls within a relatively narrow range among neurologically intact controls, but is substantially reduced in some individuals who have experienced a stroke, indicating a reduced ability to stabilize their gait pattern. This measure relates the mechanical state of the body at the start of each step (mediolateral pelvis displacement and velocity of the pelvis relative to the stance foot) to the step width at the end of the step. Specifically, the partial linear correlation be

4-week assessment
GroupValue95% CI
Error Reduction-0.02± 0.22
Error Augmentation0.12± 0.20
Activity Matched Control-0.04± 0.14
8-week assessment
GroupValue95% CI
Error Reduction0.05± 0.15
Error Augmentation0.11± 0.20
Activity Matched Control-0.02± 0.16
12-week assessment
GroupValue95% CI
Error Reduction0± 0.08
Error Augmentation0.08± 0.18
Activity Matched Control0.01± 0.12
Follow-up assessment (after 12 weeks)
GroupValue95% CI
Error Reduction-0.01± 0.16
Error Augmentation0.11± 0.18
Activity Matched Control0± 0.14
Functional Gait Assessment (Change From Baseline) Secondary · baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks

A commonly-used clinical test to quantify balance and stability during various walking tasks. The minimum value is 0, the maximum value is 30, and higher scores indicate better outcomes. The total maximum value of 30 is calculated as the sum of 10 subscores, each of which has a scoring range of 0-3 and represents a distinct walking task. The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks).

4-week assessment
GroupValue95% CI
Error Reduction0.1± 1.8
Error Augmentation1.5± 2.3
Activity Matched Control1.6± 2.1
8-week assessment
GroupValue95% CI
Error Reduction0.8± 2.3
Error Augmentation1.9± 2.7
Activity Matched Control2.5± 2.8
12-week assessment
GroupValue95% CI
Error Reduction1.5± 2.5
Error Augmentation2.9± 1.9
Activity Matched Control2.1± 1.8
Follow-up assessment (after 12 weeks)
GroupValue95% CI
Error Reduction1.0± 2.5
Error Augmentation2.2± 2.5
Activity Matched Control1.9± 3.5
Activities-specific Balance Confidence Scale (Change From Baseline) Secondary · baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks

A commonly-used clinical scale that quantifies an individual's confidence in performing various tasks requiring balance. The minimum value is 0, the maximum value is 100, and higher scores indicate a better outcome. The overall score is calculated as the mean of 16 subscores, each of which can range of 0 to 100 and represents self-efficacy at a distinct movement task. The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks).

4-week assessment
GroupValue95% CI
Error Reduction2.2± 11.2
Error Augmentation-0.6± 6.9
Activity Matched Control3.7± 10.3
8-week assessment
GroupValue95% CI
Error Reduction2.5± 12.9
Error Augmentation-1.2± 4.9
Activity Matched Control4.1± 16.2
12-week assessment
GroupValue95% CI
Error Reduction6.1± 16.4
Error Augmentation2.8± 6.8
Activity Matched Control5.4± 12.5
Follow-up assessment (after 12 weeks)
GroupValue95% CI
Error Reduction8.1± 14.7
Error Augmentation4.6± 7.9
Activity Matched Control3.7± 22.8
10-meter Walk Test (Change From Baseline) Secondary · baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks

A commonly-used clinical test to quantify general gait function. Walking speed is measured during the middle 6-meter portion of a 10-meter straight line path. The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks).

4-week assessment
GroupValue95% CI
Error Reduction0.01± 0.08
Error Augmentation0.03± 0.08
Activity Matched Control0.03± 0.08
8-week assessment
GroupValue95% CI
Error Reduction0.02± 0.10
Error Augmentation0.04± 0.07
Activity Matched Control0.04± 0.10
12-week assessment
GroupValue95% CI
Error Reduction0.05± 0.14
Error Augmentation0.02± 0.08
Activity Matched Control0.06± 0.10
Follow-up assessment (after 12 weeks
GroupValue95% CI
Error Reduction0.01± 0.15
Error Augmentation0.01± 0.11
Activity Matched Control0.01± 0.11
Fall Incidence Secondary · 6 months (during 12 week follow-up period)

Self-report history of fall occurrence, quantified by the average number of falls per participant in each group during the 12-week period that followed completion of the study's intervention component

GroupValue95% CI
Error Reduction0.50± 0.20
Error Augmentation0.29± 0.14
Activity Matched Control0.62± 0.23
Fear of Falling Secondary · 6 months (at completion of 12-week Follow-up period)

Self-report statement of whether a participant has a fear of falling

GroupValue95% CI
Error Reduction4
Error Augmentation5
Activity Matched Control4

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected over a three-year period, corresponding from the time when the first participant was enrolled into the intervention to the time when the overall intervention ended.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Error Reduction
Serious: 0/18 (0%)
Deaths: 0/18
Error Augmentation
Serious: 0/18 (0%)
Deaths: 0/18
Activity Matched Control
Serious: 1/18 (6%)
Deaths: 0/18

Serious adverse events (1 terms)

ReactionSystemError ReductionError AugmentationActivity Matched Control
StrokeVascular disorders

Most-reported serious reactions: Stroke.

Data from ClinicalTrials.gov NCT02964039 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Effect of mediolateral leg perturbations on walking balance in people with chronic stroke: A randomized controlled trial.
    Krause AA, Reimold NK, Embry AE, Knight HL, et al · · 2024 · cited 3× · PMID 39378234 · DOI 10.1371/journal.pone.0311727

Verify or expand the search:

Other recruiting trials for Stroke

Currently open trials in the same condition.

Other VA Office of Research and Development trials

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02964039.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing