Clinical trial NCT02128152: Mobility Training Using Exoskeletons for Functional Recovery After Stroke
Official title: Effect of Mobility Training Using Robotic Exoskeletons on Functional Recovery in Individuals With Severe Stroke
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Severe Stroke or Similar Neurological Muscle Weakness
Keywords: stroke
exoskeleton
Ekso
ambulation
robotics
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2014-05-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: \*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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in 6 Minute Walk Test With VO2 Analysis
timeFrame: Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit)
measure: Change in 10 Meter Walk Test
timeFrame: Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit)
Secondary outcomes:
measure: Change in Fugl-Meyer Assessment of Motor Recovery After Stroke
timeFrame: Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit)
measure: Change in Mini Mental Status Examination
timeFrame: Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit)
measure: Change in Modified Falls Efficacy Scale
timeFrame: Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit)
measure: Change in Activities Specific Balance Confidence Scale
timeFrame: Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit)
measure: Change in Community Participation Indicators
timeFrame: Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit)
measure: Change in Visual Analog Scale
timeFrame: Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit)
measure: Change in The Psychosocial Impact Of Assistive Devices Scale
timeFrame: Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit)
measure: Change in Patient Health Questionnaire-9
timeFrame: Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit)
measure: Change in Stroke Specific Quality of Life
timeFrame: Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit)
measure: Change in Range of Motion
timeFrame: Session 1 (pre test, initial visit) and Session 32 (post test, 10 weeks)
measure: Change in Manual Muscle Test
timeFrame: Session 1 (pre test, initial visit) and Session 10 (post test, 10 weeks)
measure: Change in Modified Ashworth Test
timeFrame: Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit)
measure: Change in Stops While Walking Test
timeFrame: Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit)
measure: Change in Berg Balance Scale
timeFrame: Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit)
measure: Change in 5 Times Sit to Stand Test
timeFrame: Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit)
measure: Change in Timed Up And Go
timeFrame: Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit)
measure: Change in Functional Reach Test
timeFrame: Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit)
measure: Change in Modified Functional Reach
timeFrame: Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Arun Jayaraman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: