Clinical trial NCT04251091: Ankle Exosuit Training in the Clinic to Community Community
Official title: Ankle Exosuit Training in the Clinic to Community
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: exoskeleton
ambulation
robotics
Stroke
walking
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2020-01-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in 10 Meter Walk Test from baseline gait speed
timeFrame: Baseline Day 1-3, Midpoint at week 6, Post-intervention at week 12
Secondary outcomes:
measure: Change in 6 Minute Walk Test in distance from baseline
timeFrame: Baseline Day 1-3, Midpoint at week 6, Post-intervention at week 12
measure: Functional Gait Assessment (FGA)
timeFrame: Baseline Day 1-3, Midpoint at week 6, Post-intervention at week 12
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Arun Jayaraman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.