Ankle Exosuit Training in the Clinic to Community Community

Stroke Clinical Trial

Official title:

Ankle Exosuit Training in the Clinic to Community

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04251091
• Other study ID #: STU00209869
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 10, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Shirley Ryan AbilityLab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Treadmill walking
Up to 5 bouts of 6 minutes walking on the treadmill with rest breaks allowed between sets
• Overground Walking
Up to 5 bouts of 6 minutes walking overground with rest breaks allowed between sets

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Arun Jayaraman, PT, PhD	U.S. Department of Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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