StrokePhase 4NCT01499862

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

A Phase 4 study testing Tibion Bionic Leg in people with Stroke, run by Tibion Bionics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages 40 to 60 years
Conditions the study is for: Stroke
What is being tested?: Tibion Bionic Leg
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteUnited States
Study dates: Jun 2009to Dec 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Male or female
Aged 40 to 60 years
One year status post-stroke
Able to walk at least 10 meters
Independence in self-care

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Bakar Community Center at the University of California San Francisco
San Francisco, California, 94158-2332

Other trials in United States

About this study

Official title: Discriminatory Neurosensory Stimulation Neurological H5394-11417-15

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).

Conditions: Stroke
Being tested: Tibion Bionic Leg
Keywords: Stroke, Tibion, Bionics, Rehab, Therapy, Robotics, Intention
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT01499862
Study group	Role	What they receive
Tibion Arm	Experimental	Arm of the study in which enrolled post-stroke subjects undergo rehabilitative therapy with the Tibion Bionic Leg. Receives: Device: Tibion Bionic Leg

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.

Secondary outcomes (4)

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.
Measured: 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.
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.
Measured: 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.
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)
Measured: 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.
Step Length
The length of the patient's average step, in meters, as measured during comfortable walking.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Dec 2011

First posted26 Dec 2011 (estimated)
Study startJun 2009
Primary completionDec 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01499862
Sponsor's protocol ID: CP 0003
Status last verified: Jun 2013
First submitted: 20 Dec 2011
Last updated: 2 Aug 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 22082495

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
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Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
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Metformin in Acute Ischemic Stroke
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Music Therapy in Post-Stroke Patients: A Clinical Trial
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Not yet recruitingObservational study
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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Discriminatory Neurosensory Stimulation Neurological H5394-11417-15
ClinicalTrials.gov ID: NCT01499862
Acronym / sponsor ID: CP 0003
Conditions: Stroke
Keywords: Stroke, Tibion, Bionics, Rehab, Therapy, Robotics, Intention
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 3 participants (actual)
Lead sponsor: Tibion Bionics, Inc.Industry (pharma, biotech, devices)
Collaborators: University of California, San Francisco
Study start: Jun 2009
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 26 Dec 2011 (estimated)
Results: Posted 2 Aug 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Tibion Arm	Experimental	Device: Tibion Bionic LegArm of the study in which enrolled post-stroke subjects undergo rehabilitative therapy with the Tibion Bionic Leg.

Who may qualify

Ages: 40 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Male or female
Aged 40 to 60 years
One year status post-stroke
Able to walk at least 10 meters
Independence in self-care

Key exclusion criteria (8 listed)

Medically unstable
Major cardiopulmonary deficiency
Major depression
Significant cognitive deficit
Currently receiving gait training

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tibion Bionic LegA 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.	Device	Tibion Arm

Primary outcome

Ambulation Speed
Time frame: 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.
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.

4 secondary outcomes

6 Minute Walk Test (6 MWT)
Time frame: 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.
Timed Up and Go (TUG) Test
Time frame: 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.
Five Times Sit to Stand Test (5 x STS)
Time frame: 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.
Step Length
Time frame: 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.

Results and safety

Results posted to the registry on 2 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tibion Arm Baseline Assessments	3	3

Primary outcome: Ambulation Speed

Time frame: 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.. Number. Unit: meters per second (m/s)

Measure	Patient 1 n = 1	Patient 2 n = 1	Patient 3 n = 1
Baseline	0.60	0.29	0.83
End of Training	0.81	0.43	1.03
1 Month Post-Training	0.95	0.45	1.14

Population analysed: Three (3) Subjects all of whom had a plateaued with conventional Bodyweight-Supported Treadmill Training (BWSTT) participated in task-oriented mobility therapy (1.5 hours, 2-4 times per week for 4 weeks) with the Tibion Bionic Leg under the supervision of a physical therapist.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tibion Arm Baseline Assessments	0 of 3 (0%)	0 of 3 (0%)	Not reported

Limitations and caveats (from the sponsor): These results are from a small group (n of 3) of patients and should not be assumed to be consistent across all populations. Furthermore, the inherent subjective variability of patient response in physical therapy interventions should be considered.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22082495Wong 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.
Tibion Bionic TechnologiesLink provided by the sponsor.

Related trials for Stroke

Not yet recruiting
Cardiac CT Angiography in Acute Stroke Imaging (SCOPE-CT)
Acute Ischemic Stroke and Transient Ischemic Attacks
Recruiting
OPTION-EMEA Clinical Trial
Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
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Metformin in Acute Ischemic Stroke
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Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nancy N Byl, PhD, PT principal investigator

University of California, San Francisco

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tibion Bionic Leg in people with Stroke, run by Tibion Bionics, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ambulation Speed (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01499862, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2013.