Mobility Training Using Exoskeletons for Functional Recovery After Stroke

NCT02128152 | Active Not Recruiting DMC

• 1 other identifier: STU00089523
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Severe Stroke or Similar Neurological Muscle Weakness

Keywords

stroke; exoskeleton; Ekso; ambulation; robotics

Outcome Measures

Primary Outcomes (2)

• Change in 6 Minute Walk Test With VO2 Analysis

  The 6MWT measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The minimal detectable change distance for people with sub-acute stroke is 60.98 meters15. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. This test will be administered while wearing a mask to measure oxygen consumption.

  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)

• Change in 10 Meter Walk Test

  This test will examine the patient's gait speed. Patients will be directed to walk at their preferred maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 sec). The test will be recorded 2 times, with adequate rest in between. The average of the 2 times should be recorded.

  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 (18)

• Change in Fugl-Meyer Assessment of Motor Recovery After Stroke

  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)

• Change in Mini Mental Status Examination

  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)

• Change in Modified Falls Efficacy Scale

  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)

• Change in Activities Specific Balance Confidence Scale

  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)

• Change in Community Participation Indicators

  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)

Study Arms (1)

Ekso Training Safety and Efficacy

EXPERIMENTAL

Device: Ekso exoskeleton

Interventions

Ekso exoskeleton DEVICE

Also known as: Ekso by Ekso Bionics Inc.

Ekso Training Safety and Efficacy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• U.S. Department of Education: collaborator

Study Sites (1)

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Arun Jayaraman, PT, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: May 1, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

US (1)