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Assistive ExoSkeletons to Enable Wearable Rehabilitation Robotics

Primary Purpose

Diabetic Foot Ulcer, Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exoskeleton
Sponsored by
Results Group LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetic Foot Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Self-reported history of diabetic foot ulcer

Exclusion Criteria:

  • Unable to continuously ambulate/walk ≥ 40 feet without an assistive device, such as a cane or walker
  • Signs/symptoms of an infected foot lesion/ulcer as determined by a basic foot exam
  • Trans-metatarsal foot amputation or more significant amputation.
  • Symptomatic for signs/symptoms of cardiovascular disease as determined from interpretation of the 2017 PAR-Q+ (predicated on participant responses of "yes" indicating symptomatic/unstable medical conditions to page 2 and page 3 of the 2017 PAR-Q)
  • Participants will be excluded from this study if they demonstrate pre-participation, or chronic, signs/symptoms of hypoglycemia: Confusion, unusual headache, unusual visual disturbances, self-reported mental dullness, shakiness, self-reported weakness, abnormal sweating, undue nervousness/anxiety, and/or tingling of the mouth, toes, and/or fingers or if they answer yes to question 5b and 5c of the 2017 PAR-Q+ .
  • Participants will be temporarily excluded from this study if they are symptomatic for acute illness such as cold or fever. If the participant is symptomatic for acute illness such as cold or fever, participation will be reconsidered upon illness resolution.
  • If participants answer yes to question 4a of the 2017 PAR-Q+ and if they demonstrate pre-study participation resting blood pressure < 90/60 mmHg and >140/90 mmHg .

Sites / Locations

  • Rancho Los Amigos
  • Southern CT State University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Primary Arm

Arm Description

Participants will be used as their own controls. Participants will be evaluated using exo-skeletons with non-motorized spring elements in parallel to the Achilles tendon. Up to 5 different levels of spring force will be evaluated to evaluate the impact upon plantar pressure and measures of fall risk.

Outcomes

Primary Outcome Measures

Forefoot plantar pressure
Measurements of the force and pressure on the bottom of the front of the foot

Secondary Outcome Measures

Measures of fall risk
Measurements of postural sway, balance and gait speed to provide an indication of participant's risk of falling while wearing different shoes.

Full Information

First Posted
October 22, 2018
Last Updated
February 27, 2020
Sponsor
Results Group LLC
Collaborators
Southern Connecticut State University
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1. Study Identification

Unique Protocol Identification Number
NCT03717233
Brief Title
Assistive ExoSkeletons to Enable Wearable Rehabilitation Robotics
Official Title
Assistive ExoSkeleton & ExoTendon Platform to Enable Wearable Rehabilitation Robotics
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 18, 2018 (Actual)
Primary Completion Date
October 17, 2019 (Actual)
Study Completion Date
October 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Results Group LLC
Collaborators
Southern Connecticut State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Study will evaluate the use of lower-limb assistive exo-skeletons worn on the ankle and foot. Participants will wear the exo-skeletons and walk in a safe environment. Measurements will be taken to determine how the exo-skeletons affect the pressure on the feet of people with diabetic foot ulcer and how they walk.
Detailed Description
Study will evaluate the use of lower-limb assistive exo-skeletons worn on the ankle and foot. Participants will include those with self-described history of Diabetic Foot Ulcer and age-matched healthy volunteers. Participants will wear the exo-skeletons and will be asked to walk 32 feet, and to stand quietly for 30 seconds. Measurements will be taken to evaluate how the exoskeletons affect how people walk, and will also evaluate the pressure on the bottom of their feet. These measurements will be repeated multiple times to evaluate four different exo-tendon spring rates, and two sets of control shoes. Exo-skeletons have been shown to reduce the pressure on the bottoms of people's feet and to reduce the effort to walk. This study is necessary to understand the contribution of different levels of exo-skeleton spring force to these effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer, Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants will be evaluated as their own controls.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Primary Arm
Arm Type
Experimental
Arm Description
Participants will be used as their own controls. Participants will be evaluated using exo-skeletons with non-motorized spring elements in parallel to the Achilles tendon. Up to 5 different levels of spring force will be evaluated to evaluate the impact upon plantar pressure and measures of fall risk.
Intervention Type
Device
Intervention Name(s)
Exoskeleton
Intervention Description
Ankle-foot exoskeleton - device to help reduce load on the bottom of the front of the foot
Primary Outcome Measure Information:
Title
Forefoot plantar pressure
Description
Measurements of the force and pressure on the bottom of the front of the foot
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Measures of fall risk
Description
Measurements of postural sway, balance and gait speed to provide an indication of participant's risk of falling while wearing different shoes.
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Self-reported history of diabetic foot ulcer Exclusion Criteria: Unable to continuously ambulate/walk ≥ 40 feet without an assistive device, such as a cane or walker Signs/symptoms of an infected foot lesion/ulcer as determined by a basic foot exam Trans-metatarsal foot amputation or more significant amputation. Symptomatic for signs/symptoms of cardiovascular disease as determined from interpretation of the 2017 PAR-Q+ (predicated on participant responses of "yes" indicating symptomatic/unstable medical conditions to page 2 and page 3 of the 2017 PAR-Q) Participants will be excluded from this study if they demonstrate pre-participation, or chronic, signs/symptoms of hypoglycemia: Confusion, unusual headache, unusual visual disturbances, self-reported mental dullness, shakiness, self-reported weakness, abnormal sweating, undue nervousness/anxiety, and/or tingling of the mouth, toes, and/or fingers or if they answer yes to question 5b and 5c of the 2017 PAR-Q+ . Participants will be temporarily excluded from this study if they are symptomatic for acute illness such as cold or fever. If the participant is symptomatic for acute illness such as cold or fever, participation will be reconsidered upon illness resolution. If participants answer yes to question 4a of the 2017 PAR-Q+ and if they demonstrate pre-study participation resting blood pressure < 90/60 mmHg and >140/90 mmHg .
Facility Information:
Facility Name
Rancho Los Amigos
City
Los Angeles
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Name
Southern CT State University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06515
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28859516
Citation
Roser MC, Canavan PK, Najafi B, Cooper Watchman M, Vaishnav K, Armstrong DG. Novel In-Shoe Exoskeleton for Offloading of Forefoot Pressure for Individuals With Diabetic Foot Pathology. J Diabetes Sci Technol. 2017 Sep;11(5):874-882. doi: 10.1177/1932296817726349.
Results Reference
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Assistive ExoSkeletons to Enable Wearable Rehabilitation Robotics

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