Ankle Exosuit Training in the Clinic to Community Community

NCT04251091 | Active Not Recruiting DMC

• 1 other identifier: STU00209869
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

exoskeleton; ambulation; robotics; Stroke; walking

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in 6 Minute Walk Test in distance from baseline

  Baseline Day 1-3, Midpoint at week 6, Post-intervention at week 12

• Functional Gait Assessment (FGA)

  Baseline Day 1-3, Midpoint at week 6, Post-intervention at week 12

Study Arms (1)

ReWalk Soft Exosuit

EXPERIMENTAL

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; Other: Overground Walking

Interventions

Treadmill walking OTHER

Up to 5 bouts of 6 minutes walking on the treadmill with rest breaks allowed between sets

ReWalk Soft Exosuit

Overground Walking OTHER

Up to 5 bouts of 6 minutes walking overground with rest breaks allowed between sets

ReWalk Soft Exosuit

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arun Jayaraman, PT, PhD: lead
• U.S. Department of Education: collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  PMID: 35655180 DERIVED

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: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: January 31, 2020
• Study Start: January 10, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

US (1)