Trial Outcomes & Findings for Powered Orthotic Exoskeleton Training in Stroke (NCT NCT04241848)
NCT ID: NCT04241848
Last Updated: 2025-06-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
Change from Baseline after completing 36 training sessions (approximately three months time)
Results posted on
2025-06-10
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
4
|
|
Overall Study
COMPLETED
|
7
|
3
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Powered Orthotic Exoskeleton Training in Stroke
Baseline characteristics by cohort
| Measure |
Powered Orthotic Exoskeleton Training Group
n=7 Participants
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.
|
Control Group
n=3 Participants
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.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 10 • n=5 Participants
|
54.7 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
62 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Time Since Stroke
|
6.6 years
STANDARD_DEVIATION 4.1 • n=5 Participants
|
6.7 years
STANDARD_DEVIATION 2.1 • n=7 Participants
|
6.7 years
STANDARD_DEVIATION 3.49 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline after completing 36 training sessions (approximately three months time)Population: 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.
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.
Outcome measures
| Measure |
Powered Orthotic Exoskeleton Training Group
n=7 Participants
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.
|
Control Group
n=3 Participants
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.
|
|---|---|---|
|
Five Times Sit to Stand Test (5xSTS)
Change from Baseline after completing training, assessed while not wearing the Powered Exoskeleton
|
-20.3 seconds
Standard Deviation 14.2
|
-10.9 seconds
Standard Deviation 16.9
|
|
Five Times Sit to Stand Test (5xSTS)
Change from Baseline after completing training, assessed while wearing the Powered Exoskeleton
|
-9.3 seconds
Standard Deviation 5.3
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline after completing 36 training sessions (approximately 3 months time)Population: 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.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline after completing 36 training sessions (approximately three months time)Population: 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
Stepping parameters will be assessed using an instrumented carpet to determine if the paretic limb has more equitable and symmetrical load.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline after completing 36 training sessions (approximately three months time)Population: 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.
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.
Outcome measures
| Measure |
Powered Orthotic Exoskeleton Training Group
n=7 Participants
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.
|
Control Group
n=3 Participants
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.
|
|---|---|---|
|
Six Minute Walk Test (6MWT)
Change from Baseline after completing training, assessed while not wearing the Powered Exoskeleton
|
59.8 meters
Standard Deviation 102.4
|
67 meters
Standard Deviation 59.4
|
|
Six Minute Walk Test (6MWT)
Change from Baseline after completing training, assessed while wearing the Powered Exoskeleton
|
57.8 meters
Standard Deviation 70.4
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline after completing 36 training sessions (approximately three months time)Population: 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.
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.
Outcome measures
| Measure |
Powered Orthotic Exoskeleton Training Group
n=7 Participants
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.
|
Control Group
n=3 Participants
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.
|
|---|---|---|
|
Ten Meter Walk Test (10MWT)
Change from Baseline after completing training, assessed while not wearing the Powered Exoskeleton
|
0.24 meters/second
Standard Deviation 0.34
|
0.19 meters/second
Standard Deviation 0.16
|
|
Ten Meter Walk Test (10MWT)
Change from Baseline after completing training, assessed while wearing the Powered Exoskeleton
|
0.17 meters/second
Standard Deviation 0.18
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline after completing 36 training sessions (approximately three months time)Population: 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.
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.
Outcome measures
| Measure |
Powered Orthotic Exoskeleton Training Group
n=7 Participants
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.
|
Control Group
n=3 Participants
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.
|
|---|---|---|
|
Timed Up and Go (TUG) Test
Change from Baseline after completing training, assessed while not wearing the Powered Exoskeleton
|
-5.9 seconds
Standard Deviation 7.9
|
-3.3 seconds
Standard Deviation 4.9
|
|
Timed Up and Go (TUG) Test
Change from Baseline after completing training, assessed while wearing the Powered Exoskeleton
|
-6.7 seconds
Standard Deviation 9
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline after completing 36 training sessions (approximately three months time)Population: 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.
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.
Outcome measures
| Measure |
Powered Orthotic Exoskeleton Training Group
n=7 Participants
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.
|
Control Group
n=3 Participants
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.
|
|---|---|---|
|
Step Length of Paretic (Pa) Lower Extremities (LE)
Change from Baseline after completing training, assessed while not wearing the Powered Exoskeleton
|
8.4 centimeter
Standard Deviation 15.5
|
2.2 centimeter
Standard Deviation 7.2
|
|
Step Length of Paretic (Pa) Lower Extremities (LE)
Change from Baseline after completing training, assessed while wearing the Powered Exoskeleton
|
9.3 centimeter
Standard Deviation 8
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline after completing 36 training sessions (approximately three months time)Population: 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.
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.
Outcome measures
| Measure |
Powered Orthotic Exoskeleton Training Group
n=7 Participants
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.
|
Control Group
n=3 Participants
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.
|
|---|---|---|
|
Step Length of Non-paretic (NP) Lower Extremities (LE)
Change from Baseline after completing training, assessed while not wearing the Powered Exoskeleton
|
6.4 centimeter
Standard Deviation 10.3
|
2.3 centimeter
Standard Deviation 2.4
|
|
Step Length of Non-paretic (NP) Lower Extremities (LE)
Change from Baseline after completing training, assessed while wearing the Powered Exoskeleton
|
8.7 centimeter
Standard Deviation 5.8
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline after completing 36 training sessions (approximately three months time)Population: 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.
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.
Outcome measures
| Measure |
Powered Orthotic Exoskeleton Training Group
n=7 Participants
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.
|
Control Group
n=3 Participants
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.
|
|---|---|---|
|
Stair Climb Power Test (SCPT)
Change from Baseline after completing training, assessed while not wearing the Powered Exoskeleton
|
-7.3 seconds
Standard Deviation 3.3
|
-8.1 seconds
Standard Deviation 5.7
|
|
Stair Climb Power Test (SCPT)
Change from Baseline after completing training, assessed while wearing the Powered Exoskeleton
|
-9.3 seconds
Standard Deviation 7.7
|
—
|
Adverse Events
Powered Orthotic Exoskeleton Training Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Powered Orthotic Exoskeleton Training Group
n=12 participants at risk
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.
|
Control Group
n=4 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Increased pain on the right side after using the Powered Orthotic Exoskeleton
|
8.3%
1/12 • Number of events 1 • 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).
|
0.00%
0/4 • 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).
|
|
Surgical and medical procedures
Cataract Procedure
|
0.00%
0/12 • 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).
|
25.0%
1/4 • Number of events 1 • 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).
|
|
Musculoskeletal and connective tissue disorders
Fall, Taken Place Outside of the Subject's Participation in Research
|
0.00%
0/12 • 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).
|
25.0%
1/4 • Number of events 1 • 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).
|
|
Ear and labyrinth disorders
Epigastric Pain and Dizziness, Taken Place Outside of the Subject's Participation in Research
|
8.3%
1/12 • Number of events 1 • 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).
|
0.00%
0/4 • 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).
|
|
Musculoskeletal and connective tissue disorders
Fall, Taken Place During the Subject's Participation in Research
|
0.00%
0/12 • 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).
|
25.0%
1/4 • Number of events 1 • 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).
|
|
Renal and urinary disorders
Loss of Consciousness due to Urinary Tract Infections
|
8.3%
1/12 • Number of events 1 • 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).
|
0.00%
0/4 • 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).
|
Additional Information
Dr. Ann Spungen
James J. Peters VA Medical Center, Spinal Cord Damage Research Center
Phone: (718) 584-9000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place