Ankle Exosuit Training in the Clinic to Community Community

Sponsor

Arun Jayaraman, PT, PhD (Other)

Overall Status

Recruiting

CT.gov ID

NCT04251091

Collaborator

U.S. Department of Education (U.S. Fed)

Enrollment

Location

Arm

29.6

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 protocolPrevious 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 :

Jan 10, 2020

Anticipated Primary Completion Date :

May 31, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in 10 Meter Walk Test from baseline gait speed [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

Change in 6 Minute Walk Test in distance from baseline [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.
Functional Gait Assessment (FGA) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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