Stroke
Conditions
Keywords
exoskeleton, gait, kinematics, EMG, stair climbing
Brief summary
To investigate the effect of a robotic exoskeleton on kinematics, muscle activity, ground reaction forces and spatiotemporal characteristics during walking in persons post stroke.
Detailed description
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).
Interventions
DEVICERobotic exoskeleton for walking assist
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.
Sponsors
Honda Research and Development Americas
College of St. Scholastica, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Within-subject design
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* ≥12 weeks but \<1 year post stroke at time of study participation * Age: 18-85 years * Ability to walk a minimum of 10 meters with standby assistance with or without orthosis or assistive device (Functional Ambulation categories 3, 4 or 5) * Able to follow three step commands * Express the ability to understand study tasks and purpose * Able and willing to provide written informed consent * Living in the community with the ability to travel to maurices Community Clinic for testing * Willingness to wear the StepWatch pedometer for a period of 3 days in their home * (If applicable) ≥ 90 days post major orthopedic surgery (such as a joint replacement) * (If applicable) ≥ 6 months post cardiac surgery
Exclusion criteria
* Serious cardiac conditions (hospitalized for myocardial infarction or heart surgery within 3 months, congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living) * Severe arthritis or orthopedic conditions that limit lower extremity range of motion (\> 10° or \< 90° knee flexion, lacking \> 25° hip extension, \>15° from neutral plantar flexion.) * Preexisting neurologic disorders such as Dementia, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Parkinson's Disease or Ataxia. * History of lower limb amputation, non-healing ulcers, legal blindness or severe visual impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gait Kinematics | Gait kinematics were measured in each of 4 conditions during one 2-hour session for each participant. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lower Limb Electromyography (EMG) | Measured during swing phase of gait during each of 4 walking conditions during a single data collection session. | Average max EMG of affected tibialis anterior muscle measured during swing phase for walking conditions using Delsys Tringo EMG sensors. Sample rate 2000Hz. |
| Ground Reaction Force at Terminal Stance | Force data will be measured at a single time point (in one 2-hour session) for each participant in each of 4 conditions. | 2 Force platforms were used to quantify ground reaction forces at terminal stance for the affected lower limbs during gait. Sample rate 1200Hz. |
| Stair Climbing Ascend/Descend Test | Stairs will be measured at a single time point (in one 2-hour session) for each participant | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Walking | — |
|---|---|---|
| Activities Specific Balance Confidence Scale | 72.9 units on a scale STANDARD_DEVIATION 20.2 | — |
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 7 Participants | — |
| Age, Categorical Between 18 and 65 years | 4 Participants | — |
| Age, Continuous | 67.5 years STANDARD_DEVIATION 12.7 | — |
| Fugl-meyer Assessment | 30.5 units on a scale STANDARD_DEVIATION 1.5 | — |
| Height | 163 cm STANDARD_DEVIATION 9.4 | — |
| Montreal Cognitive Assessment (MoCA) | 22.4 units on a scale STANDARD_DEVIATION 4.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 11 Participants | — |
| Sex: Female, Male Female | 6 Participants | — |
| Sex: Female, Male Male | 5 Participants | — |
| Steps per day | 2783 steps STANDARD_DEVIATION 1512 | — |
| Stroke affected side was left | 9 Participants | — |
| Time post stroke | 7.3 months STANDARD_DEVIATION 4 | — |
| weight | 81 kg STANDARD_DEVIATION 22.2 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
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.
Time frame: Gait kinematics were measured in each of 4 conditions during one 2-hour session for each participant.
Population: For one participant data was not available for the C3 condition
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Walking | Gait Kinematics | C1 | 55.9 degrees | Standard Deviation 12.3 |
| Walking | Gait Kinematics | C2 | 57.8 degrees | Standard Deviation 12.4 |
| Walking | Gait Kinematics | C3 | 58.3 degrees | Standard Deviation 8.1 |
| Walking | Gait Kinematics | C4 | 56.6 degrees | Standard Deviation 12.6 |
Comparison: C2, C3, C4 were compared to C1 the comparison condition.p-value: 0.973ANOVA
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.
Time frame: Force data will be measured at a single time point (in one 2-hour session) for each participant in each of 4 conditions.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Walking | Ground Reaction Force at Terminal Stance | C1 | 103 percentage of body weight | Standard Deviation 16 |
| Walking | Ground Reaction Force at Terminal Stance | C2 | 105 percentage of body weight | Standard Deviation 9 |
| Walking | Ground Reaction Force at Terminal Stance | C3 | 104 percentage of body weight | Standard Deviation 9 |
| Walking | Ground Reaction Force at Terminal Stance | C4 | 105 percentage of body weight | Standard Deviation 10 |
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.
Time frame: Measured during swing phase of gait during each of 4 walking conditions during a single data collection session.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Walking | Lower Limb Electromyography (EMG) | C1 | 0.115 mV | Standard Deviation 0.08 |
| Walking | Lower Limb Electromyography (EMG) | C2 | 0.115 mV | Standard Deviation 0.077 |
| Walking | Lower Limb Electromyography (EMG) | C3 | 0.101 mV | Standard Deviation 0.064 |
| Walking | Lower Limb Electromyography (EMG) | C4 | 0.119 mV | Standard Deviation 0.077 |
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)
Time frame: Stairs will be measured at a single time point (in one 2-hour session) for each participant
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Walking | Stair Climbing Ascend/Descend Test | ascend (control) | 7.03 seconds |
| Walking | Stair Climbing Ascend/Descend Test | decend (control) | 7.61 seconds |
| Walking | Stair Climbing Ascend/Descend Test | ascend with HWA | 7.10 seconds |
| Walking | Stair Climbing Ascend/Descend Test | descend with HWA | 7.99 seconds |