Clinical Trial: Clinical Study of the L300 Versus Ankle-foot Orthosis (AFO) on Post-Stroke Subjects With Foot Drop

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Functional Ambulation: Standard Treatment vs. Electronic Stimulation Therapy (FASTEST)Trial in Chronic Post-Stroke Subjects With Foot Drop

Brief Summary: The objective of this study is to determine the effectiveness of the NESS L300 (L300) in improving gait parameters, function, and quality of life among stroke subjects (greater than or equal to 3 months post stroke)with drop foot.

Detailed Summary: Approximately 176 subjects with stroke that have drop foot will be enrolled from approximately 10 different sites in the United States depending on the rate of enrollment. This clinical study is proposed to show that the functional electrical stimulation (FES) delivered via the Ness L300 improves gait function, stroke-specific quality of life, and safety for persons with stroke.
Sponsor: Bioness Inc

Current Primary Outcome: Ten Meter Walk Test (10mWT) [ Time Frame: Week 30 ]

Determine gait velocity during a 10 meter walk test for subjects using the L300 versus subjects using a standard "usual" ankle-foot orthosis (AFO). Long term device effect at comfortable gait speed in m/s. Walk test results at 30 weeks will be compared to baseline speed. The mean difference (improvement) between baseline and week 30 will be presented by study arm.


Original Primary Outcome: 10mWT [ Time Frame: Baseline, Week 0, 12, 30, 36, 42 ]

Determine gait velocity during a 10mWT for subjects using the L300 versus subjects using a standard "usual" ankle-foot orthosis (AFO).


Current Secondary Outcome:

  • Berg Balance Scale (BBS) Score [ Time Frame: Week 30 ]
    Clinical measurement of balance was recorded using the Berg Balance Scale which is a highly reliable and valid test used among persons with stroke. This Scale consists of 14 items/tasks of increasing difficulty graded on a five-point ordinal scale of zero to four where zero = participant is unable to perform the task and four = participant is independent in performance of task, such that overall total score may range from zero to 56 per participant. Mean Baseline and Mean Week 30 scores were calculated and used to determine change in mean score for each study group.
  • User Satisfaction [ Time Frame: Week 30 ]
    Total user satisfaction as measured on 12 item User Satisfaction survey with maximum score 24, minimum 0, where higher score indicated greater satisfaction with device,


Original Secondary Outcome:

  • 6MWT [ Time Frame: Baseline, Week 0, 12, 30, 36, 42 ]
    Motor outcomes will be assessed with ambulation distance as measured in a timed 6MWT.
  • Fall rate [ Time Frame: Pre-study, Baseline, Week 0,6,12,16,20,24,30,36,42 ]
    Changes fall rate from 6 months prior to study start to end of study.
  • Berg Balance Scale (BBS) [ Time Frame: Baseline, Week 0, 6, 12, 30, 36, 42 ]
    Clinical measurement of balance using the Berg Balance Scale
  • Stroke Impact Scales with Folstein Mini Mental State [ Time Frame: Baseline, Week 0, 6, 12, 30, 36, 42 ]
    Quality of life using the "Participation" subscale of Stroke Impact Scale (SIS) with Folstein Mini Mental State.
  • Function Reach Test, Timed Up and Go Test, SIS-ADL, iADL, and Mobility [ Time Frame: Baseline, Week 0, 6, 12, 30, 36, 42 ]
    Functionality will be evaluted during the FRT, TUG, SIS-ADL,iADL, and Mobility


Information By: Bioness Inc

Dates:
Date Received: June 4, 2010
Date Started: May 2010
Date Completion:
Last Updated: March 28, 2016
Last Verified: March 2016