Phase 4
N=3
Mobility Training Using a Bionic Knee Orthosis in Patients Chronic Post-Stroke: A Case Series
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT01499862 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcome: Primary: Ambulation Speed — 0.60; 0.29; 0.83; 0.81 meters per second (m/s)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tibion Bionic Leg (Device)
- Age
- Adult · 40+ yrs
- Sex
- All
- Sponsor
- Tibion Bionics, Inc.
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ambulation Speed |
0.60; 0.29; 0.83; 0.81; 0.43; 1.03 | — |
| SECONDARY 6 Minute Walk Test (6 MWT) |
170; 93; 271; 207; 140; 300 | — |
| SECONDARY Timed Up and Go (TUG) Test |
21.4; 21.4; 9.14; 14.5; 23.3; 8.94 | — |
| SECONDARY Five Times Sit to Stand Test (5 x STS) |
12.1; 12.4; 11.4; 10.5; 13.0; 12.2 | — |
| SECONDARY Step Length |
0.49; 0.29; 0.54; 0.56; 0.40; 0.59 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Male or female
- Aged 40 to 60 years
- One year status post-stroke
- Able to walk at least 10 meters
- Independence in self-care
Exclusion Criteria
- Medically unstable
- Major cardiopulmonary deficiency
- Major depression
- Significant cognitive deficit
- Currently receiving gait training
- Younger than 40 years of age
- Older than 60 years of age
- Unable to walk at least 10 meters
Data sourced from ClinicalTrials.gov (NCT01499862). 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.