CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 3 enrolled
Drug / intervention
Tibion Bionic Legdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01499862
NCT01499862Phase 4Completed

Discriminatory Neurosensory Stimulation Neurological H5394-11417-15

Tibion Bionics, Inc.·interventional·Posted Dec 26, 2011·Updated Aug 2, 2013

In Brief

A Phase 4 clinical trial evaluating Tibion Bionic Leg for Stroke. Completed, enrolled 3 participants across 1 site.

Detailed Summary

This pilot study examined the effect of task-oriented mobility training in three persons chronic post-stroke using a novel, wearable, mobile intention-based robotic orthosis (Tibion Bionic Leg).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke
CountriesUnited States

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 26, 2011
Enrollment StartJun 1, 2009
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 14.5 years ago

Interventions

Tibion Bionic Legdevice

A programmable, carbon-fiber robotic leg orthosis (Tibion Bionic Leg, Tibion Corporation, Sunnyvale, CA) was used during therapy to actively supplement concentric and eccentric quadriceps function on the participant's impaired side. The device uses internal sensors at the foot and knee joint to detect intention of movement and, once a variable force threshold is passed, the devices provides appropriate assistive and resistive adjustments.