Mobility Training Using a Bionic Knee Orthosis in Patients Chronic Post-Stroke: A Case Series
This study has been completed.
Sponsor:
Tibion Bionics, Inc.
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Tibion Bionics, Inc.
ClinicalTrials.gov Identifier:
NCT01499862
First received: December 20, 2011
Last updated: December 22, 2011
Last verified: December 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 leg orthosis (Tibion Bionic Leg).
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke |
Device: Tibion Bionic Leg |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Discriminatory Neurosensory Stimulation Neurological H5394-11417-15 |
Further study details as provided by Tibion Bionics, Inc.:
Primary Outcome Measures:
- Change in time from Baseline to walk ten (10) meters (10 Meter Walk Test) [ Time Frame: Baseline (prior to training); at conclusion of training regimen, an average of 18 weeks; 1 Month post-training ] [ Designated as safety issue: Yes ]10 Meter Walk Test: time to ambulate (walk) 10 meters, in seconds
Secondary Outcome Measures:
- Change in distance from baseline walked over six (6) minutes (6 Minute Walk Test) [ Time Frame: Baseline (prior to training); at conclusion of training regimen, an average of 18 weeks; 1 Month post-training ] [ Designated as safety issue: Yes ]Six (6) Minute Walk Test: Distance ambulated (walked) during six (6) minutes, in meters
- Change from baseline in time to rise from seated chair position, walk three (3) meters, turn, walk back to chair, and sit down (Timed Up and Go Test) [ Time Frame: Baseline (prior to training); at conclusion of training regimen, an average of 18 weeks; 1 Month post-training ] [ Designated as safety issue: Yes ]Timed Up and Go Test: Measurement of the time (in seconds) for the patient to rise from sitting from a standard arm chair, walk 3 meters, turn, walk back to the chair, and sit down. Patient wears regular footwear and customary walking aid.
- Change in time from baseline to complete the Five Times Sit to Stand Test (explained below) [ Time Frame: Baseline (prior to training); at conclusion of training regimen, an average of 18 weeks; 1 Month post-training ] [ Designated as safety issue: Yes ]Five Times Sit to Stand Test: the time, in seconds, to go from a seated to position to a standing position five times in rapid succession.
- Change in length from baseline of average step length (Step Length Test) [ Time Frame: Baseline (prior to training); at conclusion of training regimen, an average of 18 weeks; 1 Month post-training ] [ Designated as safety issue: Yes ]Step Length Test: the length of the average step, in meters.
| Enrollment: | 3 |
| Study Start Date: | June 2009 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Tibion Arm
Arm of the study in which enrolled post-stroke subjects undergo rehabilitative therapy with the Tibion Bionic Leg.
|
Device: Tibion Bionic Leg
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.
|
Eligibility| Ages Eligible for Study: | 40 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499862
Locations
| United States, California | |
| Bakar Community Center at the University of California San Francisco | |
| San Francisco, California, United States, 94158-2332 | |
Sponsors and Collaborators
Tibion Bionics, Inc.
University of California, San Francisco
Investigators
| Principal Investigator: | Nancy N Byl, PhD, PT | University of California, San Francisco |
More Information
Additional Information:
Publications:
| Responsible Party: | Tibion Bionics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01499862 History of Changes |
| Other Study ID Numbers: | CP 0003 |
| Study First Received: | December 20, 2011 |
| Last Updated: | December 22, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Tibion Bionics, Inc.:
|
Stroke Tibion Bionics Rehab |
Therapy Robotics Intention |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 19, 2013