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| ID | Type | Description | Link |
|---|---|---|---|
| I21RX003299 | U.S. NIH Grant/Contract | View source |
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Veterans who suffer strokes often have disturbances in the ability to walk that reduces independence and quality of life. Alterations in gait combined with general decreased activity are associated with reduced muscle strength of the paretic leg. This leads to cardiovascular deconditioning and reduced quality of life. There is a new and novel battery powered device (Keeogo powered orthotic exoskeleton) that uses motors that assist knee movement while walking, sitting down, and standing up. The Keeogo monitors hip movement to assist the knee, making it simple to learn how to use. If successful, this project will show how this device will help improve the ability to walk and provide evidence to support larger clinical trials in a home and community setting to improve mobility, increase muscle mass and strength in the legs, as well as improve general health and quality of life. Lastly, this device could be used to increase motivation and confidence in a person to walk for longer periods of time and distance, providing the ability to walk in places that were previously inaccessible.
Ninety percent of stroke survivors have clinically significant gait impairments that lead to secondary medical complications, including cardiovascular deconditioning and reduced quality of life (QOL). Several rehabilitative interventions that increase the level of activity and mobility have been shown to be beneficial. Challenges posed by most of these locomotor gait training interventions require recurring visits to a rehabilitation center. The recent development of novel powered exoskeletons offers a potential mechanism for stroke survivors to improve mobility in the home and community. Although the predominant research using these devices have been in persons with spinal cord injury, there are currently two devices are commercially available for use in patients with stroke and additional devices are being developed. The Keeogo powered orthotic exoskeleton is a novel device intended for persons with stroke who can ambulate but have gait impairment. This device consists of a ridged orthotic structure placed over clothing on the legs and batteries to the power motors that assist both knees in gait movement. The system monitors hip movement driven by the user and interprets this movement to apply the appropriate assistance at the knee joint. This unique approach makes learning intuitive, enabling the user only to acclimate to the system rather than learning how to control the device to initiate the desired movement.
This proposal is a randomized controlled pilot study. Fifteen veterans with chronic stroke (>6months) and who retain some ability to take steps but have impaired gait will be recruited. Ten participants will be randomized into the exoskeleton group and 5 into the control group. Both groups will be asked to complete 36 one-hour sessions of ambulation training. The exoskeleton group will train using the Keeogo powered orthotic exoskeleton and the control group will train without using their own conventional aide.
The primary aim is to determine the efficacy of training with this exoskeleton and its ability to improve transfers to standing and sitting as assessed by the five times sit-to-stand test. A secondary aim will be to assess effects of the device during overground ambulation. Outcome measurements to investigate changes of knee range of motion and loading of the paretic limb. An exploratory outcome of changes in energy expenditure during ambulation with and without the powered exoskeleton. Additional exploratory outcome measures of QOL will be determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Powered Orthotic Exoskeleton Training Group | Experimental | Participant in 36 session ambulation training using a powered orthotic exoskeleton. |
|
| Control Group | Active Comparator | Participant in 36 session ambulation training without using a powered orthotic exoskeleton. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Keeogo | Device | A new and novel type of robotic-device (Keeogo, B-temia, Inc.) was developed to provide powered assistance at the knee for persons with stroke. This device provides assistance for both knee extension and knee flexion during ambulation, transfers to standing and sitting, in addition to ascending and descending stairs. As this device isn't able to fully control the movement, it requires the ability of the patient to stand and initiate stepping. The approach the Keeogo uses to monitor the desired movement in order to appropriately provide assistance. This promotes intuitive learning for the user, minimizing the amount of instruction and practice needed to effectively ambulate allowing users to independently ambulate within one session. This device does not restrict leg movement, so the user can side-step and walk backwards. However, it does not provide assistance during these movements. |
| Measure | Description | Time Frame |
|---|---|---|
| Five Times Sit to Stand Test (5xSTS) | The 5xSTS is used to determine leg power and an aspect of transfer skill. This test will be used to assess a level of improved function while wearing the device. The test will also be used to assess a level of improved function not while wearing the device. | Change from Baseline after completing 36 training sessions (approximately three months time) |
| Measure | Description | Time Frame |
|---|---|---|
| Energy Expenditure | A portable metabolic cart will assess oxygen consumption during the two ambulation conditions (i.e., with and without the device) over a 6-minute period | Change from Baseline after completing 36 training sessions (approximately 3 months time) |
| The Ratio of Stance Time of Each Limb During Ambulation |
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Inclusion Criteria:
Exclusion Criteria:
Neurological paralysis causing an inability to stand, weight bear or take stepping movements;
Fixed contractures resulting in limited range of motion in the hip, knees, or ankles that prevent sitting, standing, walking, and/or squatting activities;
Modified Ashworth Scale for spasticity greater than 3 in the lower limbs
Able to walk at a normal walking speed (1.4 m/s, 3.2 mph) or better during the Six Minute Walk Test (6MWT)
Anthropometric incompatibility with the device
Any medical complication or co-morbidity as judged by the study physician to be contraindicated for wearing the device or walking (e.g., cardiovascular disorders, pressure ulcers, open wounds, lower limb vascular disorders, or other medical conditions); and
Pregnant or planning to become pregnant (Females only).
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| Name | Affiliation | Role |
|---|---|---|
| Ann M Spungen, EdD | James J. Peters Veterans Affairs Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James J. Peters VA Medical Center, Bronx, NY | The Bronx | New York | 10468-3904 | United States |
Where practicable, sharing should take place under a written agreement prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. However, it is permissible for final datasets in machine-readable format to be submitted to and accessed from PubMed Central (and similar sites) provided that care is taken to ensure that the individuals cannot be re-identified using other publicly available information.
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The protocol module indicates that 22 participants were enrolled in the study because 22 participants signed Informed Consent Documents (ICD) and screened for the study. Of the 22 participants who signed ICDs, six were excluded because they met at least one study exclusion criteria. In the Participant Flow module, we report that 16 participants Started this study because only 16 participants screened eligible and underwent training and data collection in either the control or intervention arms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Powered Orthotic Exoskeleton Training Group | Participant in 36 session ambulation training using a powered orthotic exoskeleton. Keeogo: A new and novel type of robotic-device (Keeogo, B-temia, Inc.) was developed to provide powered assistance at the knee for persons with stroke. This device provides assistance for both knee extension and knee flexion during ambulation, transfers to standing and sitting, in addition to ascending and descending stairs. As this device isn't able to fully control the movement, it requires the ability of the patient to stand and initiate stepping. The approach the Keeogo uses to monitor the desired movement in order to appropriately provide assistance. This promotes intuitive learning for the user, minimizing the amount of instruction and practice needed to effectively ambulate allowing users to independently ambulate within one session. This device does not restrict leg movement, so the user can side-step and walk backwards. However, it does not provide assistance during these movements. Ambulation training: Ambulation training will consist of mobility activities affecting daily life including: walking; squatting (or getting in and out of a chair); bending, kneeling or stooping (for picking an item up off of the floor); and ascending and descending stairs. Sessions will be monitored and tailored to the individual, based on their functional ability and to ensure their safety. |
| FG001 | Control Group | Participant in 36 session ambulation training without using a powered orthotic exoskeleton. Ambulation training: Ambulation training will consist of mobility activities affecting daily life including: walking; squatting (or getting in and out of a chair); bending, kneeling or stooping (for picking an item up off of the floor); and ascending and descending stairs. Sessions will be monitored and tailored to the individual, based on their functional ability and to ensure their safety. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
To ensure consistency between the Baseline Characteristics and Outcome Measures modules in the Results Section, only the Baseline Characteristics for the 10 participants who completed the study (3 Control, 7 Powered Orthotic Exoskeleton Training Group) and whose data was analyzed (and reported in the Outcome Measures) were included in the Baseline Characteristics module of the Results Section.
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| ID | Title | Description |
|---|---|---|
| BG000 | Powered Orthotic Exoskeleton Training Group | Participant in 36 session ambulation training using a powered orthotic exoskeleton. Keeogo: A new and novel type of robotic-device (Keeogo, B-temia, Inc.) was developed to provide powered assistance at the knee for persons with stroke. This device provides assistance for both knee extension and knee flexion during ambulation, transfers to standing and sitting, in addition to ascending and descending stairs. As this device isn't able to fully control the movement, it requires the ability of the patient to stand and initiate stepping. The approach the Keeogo uses to monitor the desired movement in order to appropriately provide assistance. This promotes intuitive learning for the user, minimizing the amount of instruction and practice needed to effectively ambulate allowing users to independently ambulate within one session. This device does not restrict leg movement, so the user can side-step and walk backwards. However, it does not provide assistance during these movements. Ambulation training: Ambulation training will consist of mobility activities affecting daily life including: walking; squatting (or getting in and out of a chair); bending, kneeling or stooping (for picking an item up off of the floor); and ascending and descending stairs. Sessions will be monitored and tailored to the individual, based on their functional ability and to ensure their safety. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Five Times Sit to Stand Test (5xSTS) | The 5xSTS is used to determine leg power and an aspect of transfer skill. This test will be used to assess a level of improved function while wearing the device. The test will also be used to assess a level of improved function not while wearing the device. | The control group was not assessed while wearing the Powered Exoskeleton. Only the Powered Orthotic Exoskeleton Training Group was assessed while wearing the Powered Exoskeleton. | Posted | Mean | Standard Deviation | seconds | Change from Baseline after completing 36 training sessions (approximately three months time) |
|
Adverse events were reported within five business days to the VA's Institutional Review Board (IRB) via an Adverse Event form and were also included on the Adverse Events log on the annual continuing review application in accordance with VA IRB policy. Adverse event data were collected through study completion, up to four months (three months of training sessions plus one month post cessation of training).
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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 | Powered Orthotic Exoskeleton Training Group | Participant in 36 session ambulation training using a powered orthotic exoskeleton. Keeogo: A new and novel type of robotic-device (Keeogo, B-temia, Inc.) was developed to provide powered assistance at the knee for persons with stroke. This device provides assistance for both knee extension and knee flexion during ambulation, transfers to standing and sitting, in addition to ascending and descending stairs. As this device isn't able to fully control the movement, it requires the ability of the patient to stand and initiate stepping. The approach the Keeogo uses to monitor the desired movement in order to appropriately provide assistance. This promotes intuitive learning for the user, minimizing the amount of instruction and practice needed to effectively ambulate allowing users to independently ambulate within one session. This device does not restrict leg movement, so the user can side-step and walk backwards. However, it does not provide assistance during these movements. Ambulation training: Ambulation training will consist of mobility activities affecting daily life including: walking; squatting (or getting in and out of a chair); bending, kneeling or stooping (for picking an item up off of the floor); and ascending and descending stairs. Sessions will be monitored and tailored to the individual, based on their functional ability and to ensure their safety. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased pain on the right side after using the Powered Orthotic Exoskeleton | Musculoskeletal and connective tissue disorders | Systematic Assessment | After using the Keeogo device, participant stated that they had increased pain on the right side. Study physician examined the participant. Participant stated that they have this pain chronically and is associated with activity. |
We were approved to begin this study during the summer of 2020, which was during the first wave of the COVID-19 pandemic. Due to the lockdown status of our VAMC at that time, no participants were permitted to be enrolled. In late April 2021, most restrictions were lifted at our VAMC, and we were able to begin the process of enrolling the targeted number of participants. The delayed start to study procedures, however, led to a smaller than anticipated number of subjects available for analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ann Spungen | James J. Peters VA Medical Center, Spinal Cord Damage Research Center | (718) 584-9000 | 5814 | Ann.Spungen@va.gov |
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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 | Dec 2, 2021 | Mar 26, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 2, 2021 | Oct 2, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Ambulation training while using the powered orthotic exoskeleton for 36 sessions
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|
| Ambulation training | Other | Ambulation training will consist of mobility activities affecting daily life including: walking; squatting (or getting in and out of a chair); bending, kneeling or stooping (for picking an item up off of the floor); and ascending and descending stairs. Sessions will be monitored and tailored to the individual, based on their functional ability and to ensure their safety. |
|
Stepping parameters will be assessed using an instrumented carpet to determine if the paretic limb has more equitable and symmetrical load. |
| Change from Baseline after completing 36 training sessions (approximately three months time) |
| Six Minute Walk Test (6MWT) | The 6MWT was used to assess walking endurance and was conducted on a straight 12-meter length in the hospital hallway, with a small cone marking each end of the length. Participants were instructed to walk as far as possible, at a self-selected comfortable pace, for 6 minutes while a trainer followed behind them. Participants were allowed to slow down, stop, and rest if necessary if they felt fatigued during the test. The number of completed lengths (of the 12-meter stretch of the hospital hallway) was recorded and the distance in meters was calculated. | Change from Baseline after completing 36 training sessions (approximately three months time) |
| Ten Meter Walk Test (10MWT) | The 10MWT was used to assess gait speed. Participants were instructed to walk at their own comfortable pace along a 14-meter flat course in the hospital hallway while a trainer followed behind them. The initial and final two meters were used for acceleration and deceleration, respectively, while the middle ten meters of the course were times in seconds. Participants were allowed two trails, and the fastest elapsed time was used to calculate gait speed in meters/seconds. | Change from Baseline after completing 36 training sessions (approximately three months time) |
| Timed Up and Go (TUG) Test | The Timed Up and Go (TUG) Test was used as a reliable, objective measure of functional mobility. The participant was seated, with their back against the seatback, in a free-standing straight-backed chair with arms and a seat height of 17 inches. Participants were instructed to stand, walk three meters at a comfortable pace to a marked line, turn, walk back to the chair, and sit down. Timing started at the "start" command and stopped when the participant's buttocks touched the chair. Participants were allowed one practice trial prior to the timed trial. | Change from Baseline after completing 36 training sessions (approximately three months time) |
| Step Length of Paretic (Pa) Lower Extremities (LE) | Step lengths of the paretic (Pa) Lower Extremities were objective indices of spatiotemporal gait quality and were assessed with an instrumented pressure carpet (GaitRite Carpet, CIR Systems Inc., Franklin, NJ). Participants were instructed to walk at a comfortable, self-selected pace on a sensor equipped carpet that provided step length among other parameters. At least six consecutive steps on the carpet were needed to calculate the spatiotemporal parameters of the participant's gait. | Change from Baseline after completing 36 training sessions (approximately three months time) |
| Step Length of Non-paretic (NP) Lower Extremities (LE) | Step lengths of the non-paretic (NP) Lower Extremities were objective indices of spatiotemporal gait quality and were assessed with an instrumented pressure carpet (GaitRite Carpet, CIR Systems Inc., Franklin, NJ). Participants were instructed to walk at a comfortable, self-selected pace on a sensor equipped carpet that provided step length among other parameters. At least six consecutive steps on the carpet were needed to calculate the spatiotemporal parameters of the participant's gait. | Change from Baseline after completing 36 training sessions (approximately three months time) |
| Stair Climb Power Test (SCPT) | The Stair Climb Power Test was used as a measure of lower extremity (LE) power and functional mobility. Participants were instructed to ascend a flight of 10 stairs as fast as possible, using the handrail as needed for safety. Participants stood at the base of the first step. Timing started on the assessor's "go" command and stopped when both feet of the participant reached the top of the tenth step. | Change from Baseline after completing 36 training sessions (approximately three months time) |
| BG001 | Control Group | Participant in 36 session ambulation training without using a powered orthotic exoskeleton. Ambulation training: Ambulation training will consist of mobility activities affecting daily life including: walking; squatting (or getting in and out of a chair); bending, kneeling or stooping (for picking an item up off of the floor); and ascending and descending stairs. Sessions will be monitored and tailored to the individual, based on their functional ability and to ensure their safety. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Time Since Stroke | Mean | Standard Deviation | years |
|
| OG001 | Control Group | Participant in 36 session ambulation training without using a powered orthotic exoskeleton. Ambulation training: Ambulation training will consist of mobility activities affecting daily life including: walking; squatting (or getting in and out of a chair); bending, kneeling or stooping (for picking an item up off of the floor); and ascending and descending stairs. Sessions will be monitored and tailored to the individual, based on their functional ability and to ensure their safety. |
|
|
|
| Secondary | Energy Expenditure | A portable metabolic cart will assess oxygen consumption during the two ambulation conditions (i.e., with and without the device) over a 6-minute period | Energy expenditure measurements were not conducted due to equipment malfunction of the portable metabolic cart and the inability to have it fixed during the COVID-19 pandemic. This data was not and will not be collected for this study, as the study period has concluded. | Posted | Change from Baseline after completing 36 training sessions (approximately 3 months time) |
|
|
| Secondary | The Ratio of Stance Time of Each Limb During Ambulation | Stepping parameters will be assessed using an instrumented carpet to determine if the paretic limb has more equitable and symmetrical load. | The ratio of stance time of each limb during ambulation were not conducted due to equipment malfunction of the portable metabolic cart and the inability to have it fixed during the COVID-19 pandemic. This data was not and will not be collected for this study, as the study period has concluded | Posted | Change from Baseline after completing 36 training sessions (approximately three months time) |
|
|
| Secondary | Six Minute Walk Test (6MWT) | The 6MWT was used to assess walking endurance and was conducted on a straight 12-meter length in the hospital hallway, with a small cone marking each end of the length. Participants were instructed to walk as far as possible, at a self-selected comfortable pace, for 6 minutes while a trainer followed behind them. Participants were allowed to slow down, stop, and rest if necessary if they felt fatigued during the test. The number of completed lengths (of the 12-meter stretch of the hospital hallway) was recorded and the distance in meters was calculated. | The control group was not assessed while wearing the Powered Exoskeleton. Only the Powered Orthotic Exoskeleton Training Group was assessed while wearing the Powered Exoskeleton. | Posted | Mean | Standard Deviation | meters | Change from Baseline after completing 36 training sessions (approximately three months time) |
|
|
|
|
| Secondary | Ten Meter Walk Test (10MWT) | The 10MWT was used to assess gait speed. Participants were instructed to walk at their own comfortable pace along a 14-meter flat course in the hospital hallway while a trainer followed behind them. The initial and final two meters were used for acceleration and deceleration, respectively, while the middle ten meters of the course were times in seconds. Participants were allowed two trails, and the fastest elapsed time was used to calculate gait speed in meters/seconds. | The control group was not assessed while wearing the Powered Exoskeleton. Only the Powered Orthotic Exoskeleton Training Group was assessed while wearing the Powered Exoskeleton. | Posted | Mean | Standard Deviation | meters/second | Change from Baseline after completing 36 training sessions (approximately three months time) |
|
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|
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| Secondary | Timed Up and Go (TUG) Test | The Timed Up and Go (TUG) Test was used as a reliable, objective measure of functional mobility. The participant was seated, with their back against the seatback, in a free-standing straight-backed chair with arms and a seat height of 17 inches. Participants were instructed to stand, walk three meters at a comfortable pace to a marked line, turn, walk back to the chair, and sit down. Timing started at the "start" command and stopped when the participant's buttocks touched the chair. Participants were allowed one practice trial prior to the timed trial. | The control group was not assessed while wearing the Powered Exoskeleton. Only the Powered Orthotic Exoskeleton Training Group was assessed while wearing the Powered Exoskeleton. | Posted | Mean | Standard Deviation | seconds | Change from Baseline after completing 36 training sessions (approximately three months time) |
|
|
|
|
| Secondary | Step Length of Paretic (Pa) Lower Extremities (LE) | Step lengths of the paretic (Pa) Lower Extremities were objective indices of spatiotemporal gait quality and were assessed with an instrumented pressure carpet (GaitRite Carpet, CIR Systems Inc., Franklin, NJ). Participants were instructed to walk at a comfortable, self-selected pace on a sensor equipped carpet that provided step length among other parameters. At least six consecutive steps on the carpet were needed to calculate the spatiotemporal parameters of the participant's gait. | The control group was not assessed while wearing the Powered Exoskeleton. Only the Powered Orthotic Exoskeleton Training Group was assessed while wearing the Powered Exoskeleton. | Posted | Mean | Standard Deviation | centimeter | Change from Baseline after completing 36 training sessions (approximately three months time) |
|
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|
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| Secondary | Step Length of Non-paretic (NP) Lower Extremities (LE) | Step lengths of the non-paretic (NP) Lower Extremities were objective indices of spatiotemporal gait quality and were assessed with an instrumented pressure carpet (GaitRite Carpet, CIR Systems Inc., Franklin, NJ). Participants were instructed to walk at a comfortable, self-selected pace on a sensor equipped carpet that provided step length among other parameters. At least six consecutive steps on the carpet were needed to calculate the spatiotemporal parameters of the participant's gait. | The control group was not assessed while wearing the Powered Exoskeleton. Only the Powered Orthotic Exoskeleton Training Group was assessed while wearing the Powered Exoskeleton. | Posted | Mean | Standard Deviation | centimeter | Change from Baseline after completing 36 training sessions (approximately three months time) |
|
|
|
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| Secondary | Stair Climb Power Test (SCPT) | The Stair Climb Power Test was used as a measure of lower extremity (LE) power and functional mobility. Participants were instructed to ascend a flight of 10 stairs as fast as possible, using the handrail as needed for safety. Participants stood at the base of the first step. Timing started on the assessor's "go" command and stopped when both feet of the participant reached the top of the tenth step. | The control group was not assessed while wearing the Powered Exoskeleton. Only the Powered Orthotic Exoskeleton Training Group was assessed while wearing the Powered Exoskeleton. | Posted | Mean | Standard Deviation | seconds | Change from Baseline after completing 36 training sessions (approximately three months time) |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 3 |
| 12 |
| EG001 | Control Group | Participant in 36 session ambulation training without using a powered orthotic exoskeleton. Ambulation training: Ambulation training will consist of mobility activities affecting daily life including: walking; squatting (or getting in and out of a chair); bending, kneeling or stooping (for picking an item up off of the floor); and ascending and descending stairs. Sessions will be monitored and tailored to the individual, based on their functional ability and to ensure their safety. | 0 | 4 | 0 | 4 | 2 | 4 |
|
| Cataract Procedure | Surgical and medical procedures | Systematic Assessment | Subject underwent two separate cataract procedures, one for each eye. Prior to requiring the procedure, the subject only completed two training sessions. As a result, the subject was placed on hold until medical clearance from the study physician. |
|
| Fall, Taken Place Outside of the Subject's Participation in Research | Musculoskeletal and connective tissue disorders | Systematic Assessment | The fall took place at a restaurant when the subject was standing up from their chair. According to the participant, they had bruising on one side of the body and some minor scrapes on the other side. |
|
| Epigastric Pain and Dizziness, Taken Place Outside of the Subject's Participation in Research | Ear and labyrinth disorders | Systematic Assessment | Participant had complaints of epigastric pain and dizziness since waking up. When the participant reported to a medical appointment, their provider sent them to the Emergency Department (ED). They were evaluated and left the ED in stable condition. |
|
| Fall, Taken Place During the Subject's Participation in Research | Musculoskeletal and connective tissue disorders | Systematic Assessment | During study visit, the participant stumbled on the stairwell landing and caught themselves with arms and assistance from the trainer. No loss of consciousness. The participant was immediately able to right themselves and continue walking/stepping. |
|
| Loss of Consciousness due to Urinary Tract Infections | Renal and urinary disorders | Systematic Assessment | While at home, the subject lost consciousness for about 5 seconds. After regaining consciousness, they returned to being fully alert. They went to the emergency room and determined that the loss of consciousness was due to a urinary tract infection. |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010243 | Paralysis |
| Change from Baseline after completing training, assessed while wearing the Powered Exoskeleton |
|
|
| ANOVA |
| 0.250 |
| Superiority |
| Within-group comparison of Six Minute Walk Test (6MWT), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton. | t-test, 2 sided | =0.073 | Superiority |
| Change from Baseline after completing training, assessed while wearing the Powered Exoskeleton |
|
|
| ANOVA |
| 0.296 |
| Superiority |
| Within-group comparison of Ten Meter Walk Test (10MWT), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton. | t-test, 2 sided | 0.427 | Superiority |
| Change from Baseline after completing training, assessed while wearing the Powered Exoskeleton |
|
|
| ANOVA |
| 0.447 |
| Superiority |
| Within-group comparison of Timed Up and Go (TUG) Test, from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton. | t-test, 2 sided | 0.096 | Superiority |
| Change from Baseline after completing training, assessed while wearing the Powered Exoskeleton |
|
|
| ANOVA |
| =0.677 |
| Superiority |
| Within-group comparison of Step Length of Paretic (Pa) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton. | t-test, 2 sided | =0.022 | Superiority |
| Change from Baseline after completing training, assessed while wearing the Powered Exoskeleton |
|
|
| ANOVA |
| 0.666 |
| Superiority |
| Within-group comparison of Step lengths of the non-paretic (NP) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton. | t-test, 2 sided | =0.007 | Superiority |
| Change from Baseline after completing training, assessed while wearing the Powered Exoskeleton |
|
|
| ANOVA |
| =0.009 |
| Superiority |
| Within-group comparison of the Stair Climb Power Test (SCPT), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton. | t-test, 2 sided | 0.018 | Superiority |