Mobility Training Using Exoskeletons for Functional Recovery After Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Rehabilitation Institute of Chicago
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Arun Jayaraman, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier:
NCT02128152
First received: February 26, 2014
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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

Condition Intervention Phase
Severe Stroke or Similar Neurological Weakness
Device: Ekso exoskeleton
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Mobility Training Using Robotic Exoskeletons on Functional Recovery in Individuals With Severe Stroke

Resource links provided by NLM:


Further study details as provided by Rehabilitation Institute of Chicago:

Primary Outcome Measures:
  • Change in 6 Minute Walk Test With VO2 Analysis [ Time Frame: 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) ] [ Designated as safety issue: Yes ]
    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.

  • Change in 10 Meter Walk Test [ Time Frame: 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) ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Change in Fugl-Meyer Assessment of Motor Recovery After Stroke [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The purpose of the FMA is to evaluate and measure recovery in post-stroke hemiplegic patients. There are five domains assessed on a 3 point ordinal scale from 0-2. "0" is equal to "cannot perform", "1" is equal to "performs partially", and "2" is equal to "performs fully. The domain for lower extremity motor function will be used.

  • Change in Mini Mental Status Examination [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The MMSE is a brief screening tool used to provide a quantitative evaluation of cognitive impairment. MMSE briefly measures orientation to time and place, immediate recall, short-term verbal memory, calculation, language, and construct ability.

  • Change in Modified Falls Efficacy Scale [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The mFES is a 14 item self-report survey that assesses an individual's perception of balance and stability during indoor and outdoor activities of daily living. The mFES is a 10 point numerical rating scale with higher scores indicating higher confidence in the performance of the activity.

  • Change in Activities Specific Balance Confidence Scale [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The ABC is a 16-item self-report questionnaire that measures confidence in performing various ambulatory activities without falling. Items are rated on a scale ranging from 0-100, with zero representing no confidence and 100 representing complete confidence. It has good to excellent reliability and adequate construct validity, correlating with the BBS and 10mWT.

  • Change in Community Participation Indicators [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The CPI is an eighty-item self-report questionnaire that assesses the individual's satisfaction with their community participation.

  • Change in Visual Analog Scale [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The 0-10 rating scale for pain is used to gain a subjective report of the intensity of a person's pain. Zero represents "no pain" and ten represents "the most intense pain imaginable". A meaningful change would be plus or minus 3 points.

  • Change in The Psychosocial Impact Of Assistive Devices Scale [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The PIADS is 26 item questionnaires used to assess the impact assistive devices have on the quality of life of an individual who utilizes them. The questionnaire is composed of three subscales: competence, self-esteem, and adaptability. Each item is scored on a 7 point scale with a negative number indicating negative impact and a positive number indicating a positive impact.

  • Change in Patient Health Questionnaire-9 [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The PHQ-9 is a 9-item self-report screening assessment for depression. It is the depression module of the Diagnostic and Statistical Manual (4th edition). Each item is scored from 0-3; total scores may be 0-27, with higher scores representing increased severity of depression.

  • Change in Stroke Specific Quality of Life [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The SSQoL is a self-report questionnaire that is accepted as a reliable and valid way to assess health-related quality of life specific to stroke survivors. Subjects respond to 49 questions in 12 domains: mobility, energy, upper extremity function, work/productivity, mood, self-care, social roles, family roles, vision, language, thinking, and personality. Each item is rated on a 5-point Likert scale, with higher scores indicating better functioning. Domains scores (un-weighted average of item scores) and a summary score (un-weighted average of all 12 domain scores) are computed.

  • Change in Range of Motion [ Time Frame: Session 1 (pre test, initial visit) and Session 32 (post test, 10 weeks) ] [ Designated as safety issue: No ]
    Range of motion of the joints of the upper and lower extremities will be measured using a goniometer.

  • Change in Manual Muscle Test [ Time Frame: Session 1 (pre test, initial visit) and Session 10 (post test, 10 weeks) ] [ Designated as safety issue: No ]
    Manual muscle testing is a procedure for the evaluation of the function and strength of individual muscles and muscle groups based on the effective performance of a movement in relation to the forces of gravity and manual resistance.

  • Change in Modified Ashworth Test [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The Modified Ashworth Scale is a 6 point ordinal scale used to grade the amount of hypertonicity in individuals with neurological diagnoses. A score of 0 on the scale indicates no increase in tone while a score of 4 indicates rigidity. Tone is scored by passively moving the individual's limb and assessing the amount of resistance to movement felt by the examiner.

  • Change in Stops While Walking Test [ Time Frame: 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) ] [ Designated as safety issue: Yes ]
    The SWWT can be used to determine the effects of attentional demands during walking by introducing a secondary task, talking, while walking. The subject walks at a pre-selected comfortable speed. Yes or no questions are asked while the subject is walking. The test is positive if the subject stops or demonstrates deviations at a result of talking while walking.

  • Change in Berg Balance Scale [ Time Frame: 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) ] [ Designated as safety issue: Yes ]
    The BBS is a 14-item objective measure designed to assess static balance and fall risk in adult populations and is a well-accepted measure in the stroke literature. The functional activities that are assessed include sitting and standing balance during transfers, altered base of support, reaching, turning, eyes open and closed. Each item is scored from 0 to 4 points. The maximum score is 56 points. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance.

  • Change in 5 Times Sit to Stand Test [ Time Frame: 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) ] [ Designated as safety issue: Yes ]
    The 5xSST is used to measure functional lower extremity strength during the transitional movement of sit to stand. The individual is timed in moving from the start position of sitting, arms across chest, in a standard chair without armrests to fully standing five times.

  • Change in Timed Up And Go [ Time Frame: 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) ] [ Designated as safety issue: Yes ]
    The TUG is a timed test used to assess mobility, balance, and walking in people with balance impairments. The subject must stand up from a chair (which should not be leaned up against a wall), walk a distance of 3 meters, turn around, walk back to the chair and sit down - all performed as quickly and as safely as possible.

  • Change in Functional Reach Test [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The Functional Reach test is used to objectively measure a person's stability by measuring the distance an individual can reach forward while standing without taking a step. This is performed three times. The results of the last two trials are averaged to determine the result of the exam.

  • Change in Modified Functional Reach [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The Modified Functional Reach test is used to assess the stability of individuals who cannot stand by measuring the distance they can reach forward while sitting without rotating. This is performed in three different standard positions three times each with a 15 second rest break between each trial. The results of the last two trials in each direction are averaged to determine the result of the exam.


Estimated Enrollment: 60
Study Start Date: February 2014
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ekso Training Safety and Efficacy Device: Ekso exoskeleton
Other Name: Ekso by Ekso Bionics Inc.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02128152

Contacts
Contact: Matthew Knowlton, DPT (312)238-2640 mknowlton@ricres.org
Contact: Lori McGee-Koch, BS (312)238-2091 lmkoch@ricres.org

Locations
United States, Illinois
Rehabilitation Institute of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Matthew Knowlton, DPT    312-238-2640    mknowlton@ricres.org   
Contact: Lori McGee-Koch, BS    (312)238-2091    lmkoch@ricres.org   
Sponsors and Collaborators
Rehabilitation Institute of Chicago
U.S. Department of Education
Investigators
Principal Investigator: Arun Jayaraman, PT, PhD Rehabilitation Institute of Chicago
  More Information

No publications provided

Responsible Party: Arun Jayaraman, Research Scientist, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier: NCT02128152     History of Changes
Other Study ID Numbers: STU00089523
Study First Received: February 26, 2014
Last Updated: April 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rehabilitation Institute of Chicago:
stroke
exoskeleton
Ekso
ambulation
robotics

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 24, 2014