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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tibion Arm | Experimental | Arm of the study in which enrolled post-stroke subjects undergo rehabilitative therapy with the Tibion Bionic Leg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tibion Bionic Leg | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy N Byl, PhD, PT | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bakar Community Center at the University of California San Francisco | San Francisco | California | 94158-2332 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22082495 | Background | 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. |
| Label | URL |
|---|---|
| Tibion Bionic Technologies | View source |
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Patients were part of the hospitals patient population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tibion Arm Baseline Assessments | Arm of the study in which enrolled post-stroke subjects undergo rehabilitative therapy with the Tibion Bionic Leg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All subjects had reached plateau 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 Robotic Leg Orthosis (RLO) under the supervision of a physical therapist. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | Meters | 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. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tibion Arm Baseline Assessments | Arm of the study in which enrolled post-stroke subjects undergo rehabilitative therapy with the Tibion Bionic Leg. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nancy N. Byl | Department of Physical Therapy and Rehabilitation, University of California San Francisco | 415-514-4816 | byln@ptrehab.ucsf.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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. |
| 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. |
| 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. |
| Years |
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| Sex: Female, Male | The Baseline measurement is to specify the gender of each participant. | Count of Participants | Participants |
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| Lower Left Extremity Strength | The strength of the left lower extremity during active extension in pounds-force (lbf). | Median | Full Range | Pounds-Force |
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| Right Lower Extremity Strength | The strength of the right lower extremity during active extension in pounds-force (lbf). | Median | Full Range | Pounds-Force |
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| Resting Extensor Tone (Modified Ashworth Scale) | The Modified Ashworth Scale (MAS) measures muscle hypertonia, with increasing scores signifying greater resting tone of muscle groups. Scores: 0 - No tone, 1 - Slight tone, with by a catch and release or by minimal resistance at the end of the range of motion, 1+ - Slight tone, manifested by a catch, followed by minimal resistance through less than half of the ROM, 2 - Marked increase in tone through most of ROM, but affected limb(s) easily moved, 3 - Considerable tone, passive movement difficult, 4 - Affected limb(s) rigid in flexion or extension | Median | Full Range | Units on a Scale |
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| OG001 |
| Patient 2 |
Six Minute Walk Test (meters) |
| OG002 | Patient 3 | Six Minute Walk Test (meters) |
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| 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. | 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. | Posted | Number | Seconds | 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. |
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| 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) | 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. | Posted | Number | Seconds | 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. |
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| Secondary | Step Length | The length of the patient's average step, in meters, as measured during comfortable walking. | 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. | Posted | Number | Meters | 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. |
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| 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. | 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. | Posted | Number | meters per second (m/s) | 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. |
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| 3 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Title | Measurements |
|---|---|
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| 1 Month Post-Training |
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| Title | Measurements |
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| 1 Month Post-Training |
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| Title | Measurements |
|---|---|
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| 1 Month Post-Training |
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| Title | Measurements |
|---|---|
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| 1 Month Post-Training |
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