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

Primary Purpose

Stroke

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Tibion Bionic Leg

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Tibion, Bionics, Rehab, Therapy, Robotics, Intention

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Bakar Community Center at the University of California San Francisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tibion Arm

Arm Description

Arm of the study in which enrolled post-stroke subjects undergo rehabilitative therapy with the Tibion Bionic Leg.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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)

Step Length

The length of the patient's average step, in meters, as measured during comfortable walking.

Full Information

NCT ID

NCT01499862

First Posted

December 20, 2011

Last Updated

June 30, 2013

Sponsor

Tibion Bionics, Inc.

Collaborators

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT01499862

Brief Title

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

Official Title

Discriminatory Neurosensory Stimulation Neurological H5394-11417-15

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tibion Bionics, Inc.

Collaborators

University of California, San Francisco

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

Stroke, Tibion, Bionics, Rehab, Therapy, Robotics, Intention

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tibion Arm

Arm Type

Experimental

Arm Description

Arm of the study in which enrolled post-stroke subjects undergo rehabilitative therapy with the Tibion Bionic Leg.

Intervention Type

Device

Intervention Name(s)

Tibion Bionic Leg

Intervention Description

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.

Primary Outcome Measure Information:

Title

Ambulation Speed

Description

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.

Time Frame