Mobility Training Using Exoskeletons for Functional Recovery After Stroke

NCT ID: NCT02128152

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2025-12-31

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.

Conditions

Severe Stroke or Similar Neurological Muscle Weakness

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ekso Training Safety and Efficacy

Group Type: EXPERIMENTAL

Ekso exoskeleton

Intervention Type: DEVICE

Interventions

Ekso exoskeleton

Intervention Type: DEVICE

Other Intervention Names

Ekso by Ekso Bionics Inc.

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

U.S. Department of Education

FED

Sponsor Role: collaborator

Shirley Ryan AbilityLab

OTHER

Sponsor Role: lead

Responsible Party

Arun Jayaraman, PT, PhD

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arun Jayaraman, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Shirley Ryan AbilityLab

Locations

Rehabilitation Institute of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00089523

Identifier Type: -

Identifier Source: org_study_id