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Ankle Exosuit Training in the Clinic to Community Community

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251091
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : September 17, 2020
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab

Brief Summary:
This study focuses on investigating exosuit technology by evaluating its ability to provide a gait-restorative effect delivered in both clinic and community settings. The exosuit provides dynamic dorsiflexion and plantarflexion assist during walking. We will determine the effect of training parameters of intensity, repetition, and gait quality which are all key parameters associated with experience-dependent neuroplasticity. The other objective is to determine the effect of this intervention on community walking activity, walking speed, walking distance, and locomotor mechanics and energetics.

Condition or disease Intervention/treatment Phase
Stroke Other: Treadmill walking Other: Overground Walking Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Previous work has demonstrated that the tuning of the exosuit technology is important for each patient post stroke to be able to maximally utilize the technology. These modulations include when the plantarflexion force is delivered, and how to deliver the assistance within a training session however it is still unclear how to implement this into a training protocol. During a part of this study, we will explore which timing: early timing (10-20%), mid timing (50%) and late timing (90%) may be optimal for an individual and then carry out a training protocol
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ankle Exosuit Training in the Clinic to Community
Actual Study Start Date : January 10, 2020
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : June 30, 2021

Arm Intervention/treatment
Experimental: ReWalk Soft Exosuit
During this study, we will explore which timing: early timing (10-20%), mid timing (50%) and late timing (90%) may be optimal for an individual and then carry out an 18 session training protocol.
Other: Treadmill walking
Up to 5 bouts of 6 minutes walking on the treadmill with rest breaks allowed between sets

Other: Overground Walking
Up to 5 bouts of 6 minutes walking overground with rest breaks allowed between sets




Primary Outcome Measures :
  1. Change in 10 Meter Walk Test from baseline gait speed [ Time Frame: Baseline Day 1-3, Midpoint at week 6, Post-intervention at week 12 ]
    This test will examine the patient's gait speed. Patients will be directed to walk at their preferred and 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).


Secondary Outcome Measures :
  1. Change in 6 Minute Walk Test in distance from baseline [ Time Frame: Baseline Day 1-3, Midpoint at week 6, Post-intervention at week 12 ]
    The 6 Minute Walk Test (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 test will be used to determine participant's gait efficiency at baseline and at study completion. 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.

  2. Functional Gait Assessment (FGA) [ Time Frame: Baseline Day 1-3, Midpoint at week 6, Post-intervention at week 12 ]
    The Functional Gait Assessment is a 10 item test used to assess postural stability during walking tasks. It has a maximum score of 30 with each item being scored 0-3. It may be performed with or without an assistive device; however, individuals lose a point on all items requiring a device.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 - 80 years old
  • Stroke event occurred at least 6 months ago
  • Observable gait deficits
  • Able to walk without the support of another person for at least 2 minutes (with or without an assistive device or orthotic support)
  • Passive ankle dorsiflexion range of motion to neutral with the knee extended (i.e., able to achieve an angle of 90 degrees between the shank and the foot)
  • Resting heart rate between 40 - 100 bpm, inclusive
  • Resting blood pressure between 90/60 and 170/90 mmHg, inclusive
  • Medical clearance by a physician

Exclusion Criteria:

  • Score of >1 on question 1b and >0 on question 1c on the NIH Stroke Scale
  • Inability to communicate with investigators
  • Neglect or hemianopia
  • Unexplained dizziness in the last 6 months
  • Pressure ulcers or skin wounds located at human-device interface sites
  • History of significant Peripheral Artery Disease (PAD)
  • Unresolved Deep Vein Thrombosis (DVT)
  • Uncontrolled or untreated hypertension
  • Significant paretic ankle contractures (plantarflexion > 5°)
  • Psychiatric or cognitive impairments that may interfere with proper operation of the device

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251091


Contacts
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Contact: Kristen E Hohl, PT, DPT 312-238-2640 khohl@sralab.org
Contact: Lori L McGee, OT, PhD 3122382091 lmcgee@sralab.org

Locations
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United States, Illinois
Shirley Ryan AbilityLab Recruiting
Chicago, Illinois, United States, 60611
Contact: Lori McGee Koch    312-238-2091    lmcgee@sralab.org   
Contact: Lori l McGee    7732555800    lori.mcgee@gmail.com   
Sponsors and Collaborators
Arun Jayaraman, PT, PhD
U.S. Department of Education
Investigators
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Principal Investigator: Arun Jayaraman, PT, PhD Shirley Ryan AbilityLab
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Responsible Party: Arun Jayaraman, PT, PhD, Principal Investigator, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier: NCT04251091    
Other Study ID Numbers: STU00209869
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab:
exoskeleton
ambulation
robotics
Stroke
walking
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases