Mobility Training Using a Bionic Knee Orthosis in Patients Chronic Post-Stroke: A Case Series

Stroke Clinical Trial

Official title:

Discriminatory Neurosensory Stimulation Neurological H5394-11417-15

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01499862
• Other study ID #: CP 0003
• Status: Completed
• Phase: Phase 4
• First received: December 20, 2011
• Last updated: June 30, 2013
• Start date: June 2009
• Est. completion date: December 2011

Study information

• Verified date: June 2013
• Source: Tibion Bionics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 60 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	Bakar Community Center at the University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Tibion Bionics, Inc.	University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (1)

Wong CK, Bishop L, Stein J. A wearable robotic knee orthosis for gait training: a case-series of hemiparetic stroke survivors. Prosthet Orthot Int. 2012 Mar;36(1):113-20. doi: 10.1177/0309364611428235. Epub 2011 Nov 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulation Speed	Ambulation speed, in meters per second, as obtained by the Ten (10) Meter Walk Test (10 MWT). The 10 MWT measures the time required to walk 10 meters at the subject's comfortable walking pace.	Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.	Yes
Secondary	6 Minute Walk Test (6 MWT)	The total distance walked by the patient, in meters, as obtained by the Six (6) Minute Walk Test (6 MWT). The 6 MWT is performed over level ground, using any walking aids (canes, walkers, etc.) the patient requires for comfortable walking.	Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.	Yes
Secondary	Timed Up and Go (TUG) Test	The time, in seconds, for the patient to rise from sitting in a standard arm chair, walk 3 meters, turn around, walk back to the chair, and sit down. This evaluation is called the Timed Up and Go test (TUG). The patient may wear their usual footwear and use any aids (canes, walkers, etc.) they typically employ for comfortable walking.	Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.	Yes
Secondary	Five Times Sit to Stand Test (5 x STS)	The time, in seconds, for the patient to rise from a seated to full standing position and return to sitting five times in rapid succession. This evaluation is called the Five Times Sit to Stand Test (5 x STS)	Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.	Yes
Secondary	Step Length	The length of the patient's average step, in meters, as measured during comfortable walking.	Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.	Yes

External Links

•   Tibion Bionic Technologies