Stroke
Conditions
Keywords
Stroke, Tibion, Bionics, Rehab, Therapy, Robotics, Intention
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).
Interventions
DEVICETibion 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.
Sponsors
University of California, San Francisco
Tibion Bionics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ambulation Speed | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6 Minute Walk Test (6 MWT) | 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. | 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 | 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. | 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) | 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. | 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 | 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. | The length of the patient's average step, in meters, as measured during comfortable walking. |
Countries
United States
Participant flow
Recruitment details
Patients were part of the hospitals patient population.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age Continuous | 50 Years |
| Lower Left Extremity Strength | 105 Pounds-Force |
| Resting Extensor Tone (Modified Ashworth Scale) Mean Ankle Score | 2 Units on a Scale |
| Resting Extensor Tone (Modified Ashworth Scale) Mean Knee Score | 3 Units on a Scale |
| Right Lower Extremity Strength | 105 Pounds-Force |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
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.
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.
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patient 1 | Ambulation Speed | End of Training | 0.81 meters per second (m/s) |
| Patient 1 | Ambulation Speed | Baseline | 0.60 meters per second (m/s) |
| Patient 1 | Ambulation Speed | 1 Month Post-Training | 0.95 meters per second (m/s) |
| Patient 2 | Ambulation Speed | End of Training | 0.43 meters per second (m/s) |
| Patient 2 | Ambulation Speed | Baseline | 0.29 meters per second (m/s) |
| Patient 2 | Ambulation Speed | 1 Month Post-Training | 0.45 meters per second (m/s) |
| Patient 3 | Ambulation Speed | Baseline | 0.83 meters per second (m/s) |
| Patient 3 | Ambulation Speed | 1 Month Post-Training | 1.14 meters per second (m/s) |
| Patient 3 | Ambulation Speed | End of Training | 1.03 meters per second (m/s) |
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.
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.
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patient 1 | 6 Minute Walk Test (6 MWT) | End of Training | 207 Meters |
| Patient 1 | 6 Minute Walk Test (6 MWT) | Baseline | 170 Meters |
| Patient 1 | 6 Minute Walk Test (6 MWT) | 1 Month Post-Training | 250 Meters |
| Patient 2 | 6 Minute Walk Test (6 MWT) | End of Training | 140 Meters |
| Patient 2 | 6 Minute Walk Test (6 MWT) | Baseline | 93 Meters |
| Patient 2 | 6 Minute Walk Test (6 MWT) | 1 Month Post-Training | 123 Meters |
| Patient 3 | 6 Minute Walk Test (6 MWT) | Baseline | 271 Meters |
| Patient 3 | 6 Minute Walk Test (6 MWT) | 1 Month Post-Training | 285 Meters |
| Patient 3 | 6 Minute Walk Test (6 MWT) | End of Training | 300 Meters |
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)
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.
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patient 1 | Five Times Sit to Stand Test (5 x STS) | 1 Month Post-Training | 11.1 Seconds |
| Patient 1 | Five Times Sit to Stand Test (5 x STS) | End of Training | 10.5 Seconds |
| Patient 1 | Five Times Sit to Stand Test (5 x STS) | Baseline | 12.1 Seconds |
| Patient 2 | Five Times Sit to Stand Test (5 x STS) | 1 Month Post-Training | 13.2 Seconds |
| Patient 2 | Five Times Sit to Stand Test (5 x STS) | Baseline | 12.4 Seconds |
| Patient 2 | Five Times Sit to Stand Test (5 x STS) | End of Training | 13.0 Seconds |
| Patient 3 | Five Times Sit to Stand Test (5 x STS) | End of Training | 12.2 Seconds |
| Patient 3 | Five Times Sit to Stand Test (5 x STS) | Baseline | 11.4 Seconds |
| Patient 3 | Five Times Sit to Stand Test (5 x STS) | 1 Month Post-Training | 10.1 Seconds |
Secondary
Step Length
The length of the patient's average step, in meters, as measured during comfortable walking.
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.
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patient 1 | Step Length | Baseline | 0.49 Meters |
| Patient 1 | Step Length | 1 Month Post-Training | 0.59 Meters |
| Patient 1 | Step Length | End of Training | 0.56 Meters |
| Patient 2 | Step Length | Baseline | 0.29 Meters |
| Patient 2 | Step Length | 1 Month Post-Training | 0.39 Meters |
| Patient 2 | Step Length | End of Training | 0.40 Meters |
| Patient 3 | Step Length | 1 Month Post-Training | 0.60 Meters |
| Patient 3 | Step Length | End of Training | 0.59 Meters |
| Patient 3 | Step Length | Baseline | 0.54 Meters |
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.
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.
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patient 1 | Timed Up and Go (TUG) Test | End of Training | 14.5 Seconds |
| Patient 1 | Timed Up and Go (TUG) Test | Baseline | 21.4 Seconds |
| Patient 1 | Timed Up and Go (TUG) Test | 1 Month Post-Training | 12.4 Seconds |
| Patient 2 | Timed Up and Go (TUG) Test | End of Training | 23.3 Seconds |
| Patient 2 | Timed Up and Go (TUG) Test | Baseline | 21.4 Seconds |
| Patient 2 | Timed Up and Go (TUG) Test | 1 Month Post-Training | 24.0 Seconds |
| Patient 3 | Timed Up and Go (TUG) Test | Baseline | 9.14 Seconds |
| Patient 3 | Timed Up and Go (TUG) Test | 1 Month Post-Training | 10.1 Seconds |
| Patient 3 | Timed Up and Go (TUG) Test | End of Training | 8.94 Seconds |