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NCT Number: NCT04251091

Ankle Exosuit Training in the Clinic to Community 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treadmill walking

Other

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

Overground Walking

Other

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

Primary outcomes

  1. Change in 10 Meter Walk Test from baseline gait speed

    Time frame: 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 outcomes

  1. Change in 6 Minute Walk Test in distance from baseline

    Time frame: 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.

  2. Functional Gait Assessment (FGA)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Arun Jayaraman, PT, PhD

Other

Collaborators

  • U.S. Department of Education

Registry information

Official study title

Ankle Exosuit Training in the Clinic to Community

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2020
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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