Mobility Training Using Exoskeletons for Functional Recovery After Stroke
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 2/17/2019 |
| Start Date: | February 2014 |
| End Date: | December 2019 |
Effect of Mobility Training Using Robotic Exoskeletons on Functional Recovery in Individuals With Severe Stroke
The purpose of this study is to assess the safety and effectiveness of the Ekso robotic
exoskeleton in persons affected by a severe stroke.
- Primary Objectives:
- To determine if a structured high-dosage exoskeleton training program (EXTP)
results in clinically significant gains in walking recovery in individuals affected
by severe stroke.
- To determine whether timing of EXTP delivery (i.e., sub-acute vs. chronic) and
severity (non-ambulators vs. limited house-hold ambulators) affects the improvement
in gait speed and overall function following the EXTP training protocol.
- To determine whether maintenance or further improvement in gait speed can be
achieved by an intensive follow-up program of either a traditional rehabilitation
program (TRP) or extended EXTP.
- Secondary Objectives:
- To determine the effect on functional walking endurance as assessed by the 6 minute
walk test and 10 meter walk test, in high-dosage exoskeleton training program
(EXTP) vs. traditional rehabilitation program (TRP) carried in an outpatient
setting for post stroke individuals.
- To determine the effect on functional balance, as assessed by the Berg Balance
Scale, Functional Gait Assessment and Five times sit to stand measure as assessed
by the 6 minute walk test, in high-dosage exoskeleton training program (EXTP) vs.
traditional rehabilitation program (TRP) carried in an outpatient setting for post
stroke individuals.
- To determine the effect on stroke recovery, as assessed by the step counter of task
specific training in high-dosage exoskeleton training program (EXTP) vs.
traditional rehabilitation program (TRP) carried in an outpatient setting
exoskeleton in persons affected by a severe stroke.
- Primary Objectives:
- To determine if a structured high-dosage exoskeleton training program (EXTP)
results in clinically significant gains in walking recovery in individuals affected
by severe stroke.
- To determine whether timing of EXTP delivery (i.e., sub-acute vs. chronic) and
severity (non-ambulators vs. limited house-hold ambulators) affects the improvement
in gait speed and overall function following the EXTP training protocol.
- To determine whether maintenance or further improvement in gait speed can be
achieved by an intensive follow-up program of either a traditional rehabilitation
program (TRP) or extended EXTP.
- Secondary Objectives:
- To determine the effect on functional walking endurance as assessed by the 6 minute
walk test and 10 meter walk test, in high-dosage exoskeleton training program
(EXTP) vs. traditional rehabilitation program (TRP) carried in an outpatient
setting for post stroke individuals.
- To determine the effect on functional balance, as assessed by the Berg Balance
Scale, Functional Gait Assessment and Five times sit to stand measure as assessed
by the 6 minute walk test, in high-dosage exoskeleton training program (EXTP) vs.
traditional rehabilitation program (TRP) carried in an outpatient setting for post
stroke individuals.
- To determine the effect on stroke recovery, as assessed by the step counter of task
specific training in high-dosage exoskeleton training program (EXTP) vs.
traditional rehabilitation program (TRP) carried in an outpatient setting
*Procedures During Screening Process:
This study will involve recruitment of individuals who have experienced a severe stroke as
well as patients with similar neurological weakness from the inpatient setting, outpatient
clinics, as well as day rehabilitation sites through The Rehabilitation Institute of Chicago
and Northwestern Memorial Hospital.
Members of the research team will perform the initial screening of potential subjects. These
clinicians will determine study eligibility based on the inclusion and exclusion criteria
provided by Ekso Bionics in accordance with the medical recommendations of Dr. Todd Kuiken.
Potential subjects will be asked questions regarding their medical history and current level
of function. If the subject meets the criteria, researchers will then provide the subject
with a consent form. The researchers will discuss the objectives, study protocol, and the
risks and benefits of the study with each subject. The subjects will be given time to review
the form and ask any questions about the study.
Once each subject has provided informed consent, he or she will undergo a screening process
to assess joint range of motion, muscular strength (via manual muscle test), and any
spasticity present (via Modified Ashworth Scale). These measures will be used to determine
subject qualification based on inclusion and exclusion criteria. Vital signs (including heart
rate, blood pressure and oxygen saturation) will be assessed at baseline, after each session,
and during sessions as needed based on subject's signs and symptoms. Oxygen saturation and
heart rate will be monitored using a pulse oximeter. Blood pressure will be assessed with a
manual blood pressure cuff and stethoscope.
*Procedures During Treatment:
Sessions will begin with donning the Ekso device to ensure a proper fit. A physical therapist
will check the subject for proper alignment of joints with the device and check for areas of
increased pressure between the device and body. If necessary, additional padding will be
added to ensure safety and comfort or the device configuration will be modified. During the
initial sessions, skin checks will be more frequent as padding is customized, after which
they will occur at the end of each session.
After the pre-session measures, the participant will be attached to a suspension device
(Guldman overhead lift) and guarded by facility clinical/Ekso Bionics staff to ensure
participant safety. Each participant will undergo measurement, sizing, and donning of the
Ekso device in addition to skill training. Each participant will then be instructed in proper
use of the Ekso device and progressed through a series of weight shifting, balance, and
walking skill sets. Participants will be scheduled for an initial screening session and up to
26 follow-up training sessions and assessments after the 9th, 18th, and 26th session. A
follow-up assessment will also take place 3 months after the 26th training session. The
amount of sessions provided will be dependent upon compatibility with device, ability to
tolerate device use, and ability to safely ambulate using the device. A participant will
continue with each phase of the study as deemed appropriate by research staff:
- Phase 1 (1-9 training sessions): Each subject will be instructed in regards to optimal
postural alignment and weight shifting strategies to walk more efficiently in the
device. The subject will complete balance and weight shifting tasks to improve standing
balance and initiation of stepping in the device. Each subject will participate in 90
minute gait training sessions with an emphasis multi-directional weigh shifting,
balance, and initial walking tasks in the device.
- Phase 2 (10-18 training sessions): Each subject will continue with gait training in the
Ekso device utilizing training protocols developed to achieve progression with walking
from maximum-assist, tethered walking towards a greater level of independence including
non-tethered walking in the device. An assessment of gait speed, among other functional
measures, will take place during the 18th session. Each subject's gait speed will
determine the type of training that he or she will receive during the sessions 19-26.
- Phase 3 (19-26 training sessions): Subjects with a walking speed <.4m/sec will continue
with Ekso device gait training for 4 weeks at a rate of 2 sessions per week. Subjects
with a walking speed of >.4m/sec will continue with traditional physical therapy
treatment for 4 weeks at a rate of 2 sessions per week. Both types of training sessions
will focus on improving overall balance, walking distance, walking speed, & confidence
with over ground walking.
This study will involve recruitment of individuals who have experienced a severe stroke as
well as patients with similar neurological weakness from the inpatient setting, outpatient
clinics, as well as day rehabilitation sites through The Rehabilitation Institute of Chicago
and Northwestern Memorial Hospital.
Members of the research team will perform the initial screening of potential subjects. These
clinicians will determine study eligibility based on the inclusion and exclusion criteria
provided by Ekso Bionics in accordance with the medical recommendations of Dr. Todd Kuiken.
Potential subjects will be asked questions regarding their medical history and current level
of function. If the subject meets the criteria, researchers will then provide the subject
with a consent form. The researchers will discuss the objectives, study protocol, and the
risks and benefits of the study with each subject. The subjects will be given time to review
the form and ask any questions about the study.
Once each subject has provided informed consent, he or she will undergo a screening process
to assess joint range of motion, muscular strength (via manual muscle test), and any
spasticity present (via Modified Ashworth Scale). These measures will be used to determine
subject qualification based on inclusion and exclusion criteria. Vital signs (including heart
rate, blood pressure and oxygen saturation) will be assessed at baseline, after each session,
and during sessions as needed based on subject's signs and symptoms. Oxygen saturation and
heart rate will be monitored using a pulse oximeter. Blood pressure will be assessed with a
manual blood pressure cuff and stethoscope.
*Procedures During Treatment:
Sessions will begin with donning the Ekso device to ensure a proper fit. A physical therapist
will check the subject for proper alignment of joints with the device and check for areas of
increased pressure between the device and body. If necessary, additional padding will be
added to ensure safety and comfort or the device configuration will be modified. During the
initial sessions, skin checks will be more frequent as padding is customized, after which
they will occur at the end of each session.
After the pre-session measures, the participant will be attached to a suspension device
(Guldman overhead lift) and guarded by facility clinical/Ekso Bionics staff to ensure
participant safety. Each participant will undergo measurement, sizing, and donning of the
Ekso device in addition to skill training. Each participant will then be instructed in proper
use of the Ekso device and progressed through a series of weight shifting, balance, and
walking skill sets. Participants will be scheduled for an initial screening session and up to
26 follow-up training sessions and assessments after the 9th, 18th, and 26th session. A
follow-up assessment will also take place 3 months after the 26th training session. The
amount of sessions provided will be dependent upon compatibility with device, ability to
tolerate device use, and ability to safely ambulate using the device. A participant will
continue with each phase of the study as deemed appropriate by research staff:
- Phase 1 (1-9 training sessions): Each subject will be instructed in regards to optimal
postural alignment and weight shifting strategies to walk more efficiently in the
device. The subject will complete balance and weight shifting tasks to improve standing
balance and initiation of stepping in the device. Each subject will participate in 90
minute gait training sessions with an emphasis multi-directional weigh shifting,
balance, and initial walking tasks in the device.
- Phase 2 (10-18 training sessions): Each subject will continue with gait training in the
Ekso device utilizing training protocols developed to achieve progression with walking
from maximum-assist, tethered walking towards a greater level of independence including
non-tethered walking in the device. An assessment of gait speed, among other functional
measures, will take place during the 18th session. Each subject's gait speed will
determine the type of training that he or she will receive during the sessions 19-26.
- Phase 3 (19-26 training sessions): Subjects with a walking speed <.4m/sec will continue
with Ekso device gait training for 4 weeks at a rate of 2 sessions per week. Subjects
with a walking speed of >.4m/sec will continue with traditional physical therapy
treatment for 4 weeks at a rate of 2 sessions per week. Both types of training sessions
will focus on improving overall balance, walking distance, walking speed, & confidence
with over ground walking.
Inclusion Criteria:
- Subjects must be post stroke or have similar neurological weakness (2 weeks up to 6
months post and 6 months or more post)
- Subjects must be between 18-85 years of age
- Subjects must be able to fit into device and have joint motion to allow ambulation in
device
- Subjects must be able to tolerate upright standing for 30 minutes
- Subjects must have sufficient upper extremity strength and balance to allow ambulation
with device
- Subjects must have walking speed <0.4m/s, including non-ambulators
- Subjects must be able and willing to give written consent and comply with study
procedures, including follow-up visits
- Mini Mental Status Exam (MMSE) score >17
- Medical clearance from physician
Exclusion Criteria:
- Subjects must not be shorter than 60 inches or taller than 74 inches
- Subjects must not weight greater than 220 lbs
- Joint contractures of the hip, knee, or ankle that might limit normal ROM during
ambulation
- Medical issue that precludes full weight bearing and ambulation (e.g. orthopedic
injuries, pain, severe osteoporosis, or severe spasticity)
- History of significant problems with skin breakdown or current skin breakdown that
would prevent subject from wearing the device
- Cognitive and/or communicative disability (e.g. due to brain injury). Patients must be
able to follow directions and demonstrate learning capability
- Pregnancy
- Untreated deep vein thrombosis (DVT)
We found this trial at
1
site
345 E Superior St
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 238-1000
Phone: 312-238-2640
Rehabilitation Institute of Chicago The Rehabilitation Institute of Chicago (RIC) is an independent, 501(c)3, non-profit...
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