Ankle Exosuit Training in the Clinic to Community Community

Ankle Exosuit Training in the Clinic to Community

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Treadmill walking; Other: Overground Walking

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Shirley Ryan AbilityLab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 10 Meter Walk Test from baseline gait speed	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).	Baseline Day 1-3, Midpoint at week 6, Post-intervention at week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 6 Minute Walk Test in distance from baseline	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.	Baseline Day 1-3, Midpoint at week 6, Post-intervention at week 12
Functional Gait Assessment (FGA)	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.	Baseline Day 1-3, Midpoint at week 6, Post-intervention at week 12

Collaborators and Investigators

• Sponsor: Arun Jayaraman, PT, PhD
• Collaborators: U.S. Department of Education
• Investigators: Principal Investigator: Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab

Publications and helpful links

General Publications

• Shin SY, Hohl K, Giffhorn M, Awad LN, Walsh CJ, Jayaraman A. Soft robotic exosuit augmented high intensity gait training on stroke survivors: a pilot study. J Neuroeng Rehabil. 2022 Jun 3;19(1):51. doi: 10.1186/s12984-022-01034-2. Erratum In: J Neuroeng Rehabil. 2022 Sep 19;19(1):100.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): January 31, 2020

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; walking; exoskeleton; ambulation; robotics
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: STU00209869

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No