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| Name | Class |
|---|---|
| Honda Research and Development Americas | INDUSTRY |
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To investigate the effect of a robotic exoskeleton on kinematics, muscle activity, ground reaction forces and spatiotemporal characteristics during walking in persons post stroke.
Following stroke walking dysfunction is prevalent. Traditional rehabilitation methods fall short of achieving desirable walking outcomes for most people who experience stroke. Robotic methods to assist walking, such as the Honda Walking Assist Device (HWA) Robot from Honda R & D Americas Inc., are being explored as a means of improving the recovery of walking post stroke. Prior to examining the effectiveness of exoskeletal robots for walking recovery it is important to understand their effect on kinematic and muscle responses during walking. Kinematic and muscle responses at the hip during walking with the HWA were recently described.
The purpose of this study is to quantify the effect of walking with the HWA on body segments remote from the hip. These segments include knee, ankle, trunk and arm. The non-invasive measures used will include: walking kinematics (measurement of joint angles using cameras), muscle activity (Electromyography), ground reaction forces (detected by a force plate in the floor) and spatiotemporal characteristics (such as walking speed). Measures will be collected under three conditions: 1) walking at self-selected pace (control), 2) walking at self-selected pace with the HWA (4 Newton-meter assist mode for hip flexion and extension), 3) walking immediately following HWA use (aftereffect).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic exoskeleton for walking assist | Device | Participants will have two testing sessions in this within-subject design experiment. The conditions under which walking will be evaluated are control (normal) walking, walking with the exoskeleton assistance and walking immediately following exoskeleton walking. The conditions under which stair walking (ascending and descending) will be evaluated include control (normal) stairs and exoskeleton assisted stairs. Assistance is provided by The Honda Walking Assist (HWA) System is a robotic device developed by Honda R&D Corporation ®, Japan. The devices computer-activated motors use hip angle information to guide assistance delivered through the thigh straps to the legs in time with the walking cycle. The maximum torque delivered is 4 Newton-meters. |
| Measure | Description | Time Frame |
|---|---|---|
| Gait Kinematics | Difference in affected leg maximum knee flexion angle (initial swing to midswing) between conditions Kinematic Analysis of Gait will be obtained using a Qualisys 8-camera motion capture system. Sample rate 120 Hz. A modified Istituti Ortopedici Rizzoli (IOR) gait marker set (~40 markers) applied bilaterally. | Gait kinematics were measured in each of 4 conditions during one 2-hour session for each participant. |
| Measure | Description | Time Frame |
|---|---|---|
| Lower Limb Electromyography (EMG) | Average max EMG of affected tibialis anterior muscle measured during swing phase for walking conditions using Delsys Tringo EMG sensors. Sample rate 2000Hz. | Measured during swing phase of gait during each of 4 walking conditions during a single data collection session. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandra L Borstad, PhD | College of St. Scholastica | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| College of St. Scholastica-Health Science Center | Duluth | Minnesota | 55812 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Walking | In this study a single group of participants were observed in each of 4 conditions: control walking (CI), HWA walking (C2), Aftereffect (C3), and Late aftereffect (C4) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Walking | In this study a single group of participants were studied during one session in each of 4 conditions: control walking (CI), HWA walking (C2), Aftereffect (C3), and Late aftereffect (C4) |
| 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, Categorical | Count of Participants |
| 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 | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Gait Kinematics | Difference in affected leg maximum knee flexion angle (initial swing to midswing) between conditions Kinematic Analysis of Gait will be obtained using a Qualisys 8-camera motion capture system. Sample rate 120 Hz. A modified Istituti Ortopedici Rizzoli (IOR) gait marker set (~40 markers) applied bilaterally. | For one participant data was not available for the C3 condition | Posted | Mean | Standard Deviation | degrees | Gait kinematics were measured in each of 4 conditions during one 2-hour session for each participant. |
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Adverse event data were collected during the one day period of participation in the study.
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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 | Walking | In this study a single group of participants were observed in each of 4 conditions: control walking (CI), HWA walking (C2), Aftereffect (C3), and Late aftereffect (C4) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alexandra Borstad | College of St. Scholastica | 614-395-1708 | aborstad@css.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 8, 2018 | Aug 4, 2021 | Prot_SAP_000.pdf |
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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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| ID | Term |
|---|---|
| D000067190 | Exoskeleton Device |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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Within-subject design
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| Ground Reaction Force at Terminal Stance |
2 Force platforms were used to quantify ground reaction forces at terminal stance for the affected lower limbs during gait. Sample rate 1200Hz. |
| Force data will be measured at a single time point (in one 2-hour session) for each participant in each of 4 conditions. |
| Stair Climbing Ascend/Descend Test | A timed test of the ability to ascend and descend stairs with our without a rail. For this study a flight of 7 stairs will be used. The means of two trials of ascending and descending will be recorded. (Flansbjer et al., 2005) | Stairs will be measured at a single time point (in one 2-hour session) for each participant |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Height | Mean | Standard Deviation | cm |
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| weight | Mean | Standard Deviation | kg |
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| Stroke affected side was left | Count of Participants | Participants |
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| Time post stroke | Mean | Standard Deviation | months |
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| Fugl-meyer Assessment | The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. For this study the FM Lower extremity subset was used to characterize participants. Scores on this subset could range from 0-34 points. Higher scores indicate less lower extremity impairment. | Mean | Standard Deviation | units on a scale |
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| Montreal Cognitive Assessment (MoCA) | The Montreal Cognitive Assessment (MoCA) is a cognitive screening test designed to assist Health Professionals in the detection of mild cognitive impairment and Alzheimer's disease. The total possible score is 30 points. Greater than or equal to 26 is considered normal cognitive function for an adult. | Mean | Standard Deviation | units on a scale |
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| Activities Specific Balance Confidence Scale | The ABC Scale is a 16 item self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. For each item participants rate them selves from 0 (no confidence) to 100 (complete confidence). The total score is an average across the 16 items. | Mean | Standard Deviation | units on a scale |
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| Steps per day | Average steps from a 3 day sample quantified using StepWatch. | Mean | Standard Deviation | steps |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Lower Limb Electromyography (EMG) | Average max EMG of affected tibialis anterior muscle measured during swing phase for walking conditions using Delsys Tringo EMG sensors. Sample rate 2000Hz. | There was a single group that participated in this within subject design study, here we compare the outcome parameter across the four conditions for this group. | Posted | Mean | Standard Deviation | mV | Measured during swing phase of gait during each of 4 walking conditions during a single data collection session. |
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| Secondary | Ground Reaction Force at Terminal Stance | 2 Force platforms were used to quantify ground reaction forces at terminal stance for the affected lower limbs during gait. Sample rate 1200Hz. | n=9 for grf data 1 participant No HWA condition secondary to device slipping, 1 participant no clean force plate hits due to short step length. | Posted | Mean | Standard Deviation | percentage of body weight | Force data will be measured at a single time point (in one 2-hour session) for each participant in each of 4 conditions. |
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| Secondary | Stair Climbing Ascend/Descend Test | A timed test of the ability to ascend and descend stairs with our without a rail. For this study a flight of 7 stairs will be used. The means of two trials of ascending and descending will be recorded. (Flansbjer et al., 2005) | Posted | Mean | Inter-Quartile Range | seconds | Stairs will be measured at a single time point (in one 2-hour session) for each participant |
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| 11 |
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| 11 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Title | Measurements |
|---|---|
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| C4 |
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| Title | Measurements |
|---|---|
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| C4 |
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| Title | Measurements |
|---|---|
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| descend with HWA |
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