StrokeAcute EffectsNCT01558232
A Prospective Study to Evaluate Use of the Tibion Bionic Leg in Sub-Acute Post-stroke Patients
A study testing Tibion Bionic Leg in people with Stroke, run by Tibion Bionics, Inc. at 1 site in United States.
Trial summary
The objective of this clinical study is to examine acute changes in stability, force allocation, work, and mobility from using a wearable, portable, battery-operated robotic orthosis (the Tibion Bionic Leg) in subacute post-stroke persons undergoing lower extremity physical therapy. 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
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Single stroke with residual unilateral lower-extremity weakness
- Subacute post-stroke period (>3 and <12 months)
- Eligible to participate to lower extremity physical therapy
- Age 40 years or greater
- Able to ambulate at least 10 meters
- Able to ambulate without a leg brace
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- Ambulation speed less than 0.8 meters/second
- Minimum to moderate assist for transfer or ambulation by physical therapist evaluation
- Subject must understand the nature of the study and provide written informed consent prior to enrollment.
- Subject must be willing and able to attend all study sessions
Who cannot join
- Medically unstable
- Age younger than 40 years
- Acute post-stroke (< 3 months)
- Chronic post-stroke (> 12 months)
- Status-post multiple strokes
- Status-post traumatic brain injury
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- Ambulation speed greater than 0.8 meters/second
- Currently using a Knee-Ankle-Foot Orthosis (KAFO)
- Not eligible for lower extremity physical therapy
- Concomitant degenerative neurological conditions
- Not able to ambulate at least 10 meters without assistance
- Greater than moderate assist during transfer or ambulation by physical therapist evaluation
- Unable to ambulate without a leg brace
- Unable to follow instructions, complete follow-up, or provide informed consent.
- Currently enrolled in another investigational device or drug trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee Rehabilitation Hospital
Philadelphia, Pennsylvania, 19102
About this study
Official title: A Prospective, Experimental ABA Study to Evaluate Use of the Tibion Bionic Leg in Subacute Post-stroke Patients Undergoing Physical Therapy
The objective of this clinical study is to examine acute changes in stability, force allocation, work, and mobility from using a wearable, portable, battery-operated robotic orthosis (the Tibion Bionic Leg) in subacute post-stroke persons undergoing lower extremity physical therapy.
Read the detailed description
Samples text.
- 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
The Tibion Bionic Leg is used as an adjunct in post-stroke and post-operative rehabilitative physical therapy. The leg is a lightweight, wearable, portable, battery-powered, motorized leg orthosis that provides active assistance and resistance to lower limb movement during walking, stair ascent and descent, and transfers from sitting to standing (and standing to sitting).
| Study group | Role | What they receive |
|---|---|---|
| Tibion Arm | Experimental | Arm of the study in which enrolled subacute post-stroke subjects undergo lower extremity physical therapy using 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
Walking speed (comfortable and fastest possible), in meters per second, as measured by the 10 Meter Walk Test (10 MWT).
Measured: Baseline (prior to training); at conclusion of training regimen, an average of 2 weeks.
Secondary outcomes (3)
Measurements of Gait
The secondary endpoints are obtained from the GAITRite analysis system:
- Measurements of gait, such as the length and time of step, cycle, and stride, Heel to Heel base support, single/double limb support time, and stance and swing phase timing.
Measured: Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks.
Measurements of Stride
Other secondary endpoints are obtained from the GAITRite analysis system:
- Measurements of Stride such as distance, ambulation time, velocity, normalized velocity, cadence, step time, step length, cycle time.
Measured: Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks.
Measurements of Force, Stance, and Stability
Other secondary endpoints are obtained from Balance Master system:
- Limb parameters, including force in transfers from sitting to standing, standing to sitting, weight-bearing squats, and limits of stability.
Measured: Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Why it stopped: Study was terminated base on Sponsor's decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tibion Bionics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara Browne, MD, Principal investigator, Magee Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558232
- Sponsor's protocol ID
- CP001
- Acronym
- Acute Effects
- Status last verified
- Jul 2012
- First submitted
- 6 Mar 2012
- Last updated
- 9 Jul 2012
- Results posted
- No
- 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 22082495Horst RW. A bio-robotic leg orthosis for rehabilitation and mobility enhancement. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:5030-3. doi: 10.1109/IEMBS.2009.5333581.
PubMed 19964374Horst RW, Marcus RR. FlexCVA: a continuously variable actuator for active orthotics. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:2425-8. doi: 10.1109/IEMBS.2006.259950.
PubMed 17946511
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Experimental ABA Study to Evaluate Use of the Tibion Bionic Leg in Subacute Post-stroke Patients Undergoing Physical Therapy
- ClinicalTrials.gov ID
- NCT01558232
- Acronym / sponsor ID
- Acute Effects / CP001
- Conditions
- Stroke
- Keywords
- Stroke, Tibion, Bionics, Rehab, Therapy, Robotics, Intention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated base on Sponsor's decision.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tibion Bionics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 20 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical study is to examine acute changes in stability, force allocation, work, and mobility from using a wearable, portable, battery-operated robotic orthosis (the Tibion Bionic Leg) in subacute post-stroke persons undergoing lower extremity physical therapy.
Detailed description
Samples text.
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 subacute post-stroke subjects undergo lower extremity physical therapy using the Tibion Bionic Leg. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Single stroke with residual unilateral lower-extremity weakness
- Subacute post-stroke period (>3 and <12 months)
- Eligible to participate to lower extremity physical therapy
- Age 40 years or greater
- Able to ambulate at least 10 meters
Key exclusion criteria (15 listed)
- Medically unstable
- Age younger than 40 years
- Acute post-stroke (< 3 months)
- Chronic post-stroke (> 12 months)
- Status-post multiple strokes
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 LegThe Tibion Bionic Leg is used as an adjunct in post-stroke and post-operative rehabilitative physical therapy. The leg is a lightweight, wearable, portable, battery-powered, motorized leg orthosis that provides active assistance and resistance to lower limb movement during walking, stair ascent and descent, and transfers from sitting to standing (and standing to sitting). | Device | Tibion Arm |
Primary outcome
Ambulation Speed
Time frame: Baseline (prior to training); at conclusion of training regimen, an average of 2 weeks.
Walking speed (comfortable and fastest possible), in meters per second, as measured by the 10 Meter Walk Test (10 MWT).
3 secondary outcomes
Measurements of Gait
Time frame: Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks.
Measurements of Stride
Time frame: Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks.
Measurements of Force, Stance, and Stability
Time frame: Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks.
Results and safety
The study was stopped early (reason given: Study was terminated base on Sponsor's decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2012.
- 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.
- Background: PubMed 19964374Horst RW. A bio-robotic leg orthosis for rehabilitation and mobility enhancement. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:5030-3. doi: 10.1109/IEMBS.2009.5333581.
- Background: PubMed 17946511Horst RW, Marcus RR. FlexCVA: a continuously variable actuator for active orthotics. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:2425-8. doi: 10.1109/IEMBS.2006.259950.
- Tibion Bionic LegLink provided by the sponsor.
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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.
Barbara Browne, MD principal investigator
Magee Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A 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 10 inclusion and 15 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: stopped early, as of the sponsor's last update on 9 Jul 2012. 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.
Are results available for this study?
The study was stopped early (reason given: Study was terminated base on Sponsor's decision.). Results are not available in the source record.
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 training regimen, an average of 2 weeks.). 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 NCT01558232, which also lists 3 linked publications.
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 9 Jul 2012.