Characterization and Clinical Trial of a Variable Friction Shoe

January 30, 2024 updated by: Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab

Characterization and Clinical Trial of a Variable Friction Shoe, a New Paradigm of Reduced-constraint Locomotor Therapy for People Exhibiting Foot Drop Due to Stroke

More than one million Americans present with foot drop after stroke. As the aging population grows in the United States and across the world, incidence of stroke will grow as age is a key risk factor, thus there will be a need for low-cost, easy-to-use, and scalable solutions to administer proper therapy to promote recovery. This study will evaluate a Variable Friction shoe (VF shoe), a new low-cost medical device, for foot drop in an at-home setting.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators propose an alternative strategy that addresses the hazard of tripping even while allowing full volitional control of the ankle: an inexpensive Variable Friction (VF) shoe. Its outsole is high-friction during the stance phase of gait and low friction during swing; further, it produces a "click" when a scuff occurs.

The investigator's central hypothesis is that allowing volitional motion of the ankle while mitigating the hazard of tripping coupled with gait-phased auditory biofeedback will result in improved gait for subjects with drop foot. Specifically, the investigators hypothesize that the VF shoe will show significantly greater therapeutic effects than an AFO, yet maintain the desirable orthotic effect of the AFO. The study is arranged in two Aims.

Specific Aim 1: Characterize the scuff-force reduction of the VF shoe over the lifetime of use. Critical to understanding the effects of the VF shoe is a characterization of the level of scuff-force reduction.

Specific Aim 2: Evaluate the effects of the VF shoe on gait in individuals with chronic stroke and drop foot. During each 12-week phase of an AB-BA clinical trial, participants will walk for at least 30-45 minutes per day for at least 5 days per week at home.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 3 months - 1-year poststroke (the period in which patients would typically be fitted with a device for foot drop)
  2. Age 18 or older
  3. Possess a prescribed AFO or be a potential candidate for use of an AFO
  4. Can ambulate at least 10m with or without an assistive device such as a cane or walker
  5. Medically stable as determined by physician medical clearance
  6. No expected change in medications for at least 3 months
  7. Adequate stability at the ankle during stance
  8. Ability to hear clicking noise made by the VF shoe
  9. Physician approval
  10. Ability to give informed consent
  11. Able to sit unsupported and be able to follow a three-step command
  12. No unhealed/unresolved orthopedic injury to either upper or lower extremity and no history of severe back pain
  13. English speaking
  14. Willing to follow an exercise program with both devices for at least 30 minutes per day, at least 5 days per week for the full length of the program (6 months)

Exclusion Criteria:

  1. History of falling more than once a week prior to the stroke
  2. Gait speed: self-selected velocity (SSV) greater than 1.2 m/s
  3. Inability to operate in the devices safely and no caregiver assistance available
  4. Morbid obesity (body mass index >40 kg/m2)
  5. Preexisting conditions such as serious cardiac conditions, myocardial infarction, congestive heart failure, demand pacemaker, seizures, excessive dysesthetic pain, and severe lower extremity pathology that would interfere with fit or use of the shoe.
  6. Severe deficits in cognition or communication
  7. Pregnant women (status determined by self-reporting).
  8. Co-morbidity that interferes with the study (e.g. significant arthritis or joint problems, history of back injury, neuromuscular disorders, epilepsy, etc.).
  9. Severe Osteoporosis (status determined by self-reporting).
  10. Prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm AB: Variable Friction Shoe Training, AFO Training
Baseline (T0), 12 weeks Variable Friction Shoe Training, Follow-up (T1), 2-week washout, Follow-up (T2), 12 weeks AFO Training, Follow-up (T3)
Device: Variable Friction Shoe Training
The experimental group (A) will be given a pair of VF shoes and instructed to use shoes on both feet. This group will be instructed to walk on hard surfaces to engage auditory feedback of the VF shoes. This group group will be monitored daily using actigraphy and will receive weekly check-up telephone calls by a member of the research team to record number of steps, walking time, a scale for self-identified effort and perceived safety levels.
Device: Ankle Foot Orthosis (AFO) Training
The control group (B) will be provided an AFO to use on the paretic limb. This group will be instructed to walk on hard surfaces. This group group will be monitored daily using actigraphy and will receive weekly check-up telephone calls by a member of the research team to record number of steps, walking time, a scale for self-identified effort and perceived safety levels.
Experimental: Arm BA: Ankle Foot Orthosis (AFO) Training, Variable Friction Shoe Training
Baseline (T0), 12 weeks AFO Training, Follow-up (T1), 2-week washout, Follow-up (T2), 12 weeks Variable Friction Shoe Training, Follow-up (T3)
Device: Variable Friction Shoe Training
The experimental group (A) will be given a pair of VF shoes and instructed to use shoes on both feet. This group will be instructed to walk on hard surfaces to engage auditory feedback of the VF shoes. This group group will be monitored daily using actigraphy and will receive weekly check-up telephone calls by a member of the research team to record number of steps, walking time, a scale for self-identified effort and perceived safety levels.
Device: Ankle Foot Orthosis (AFO) Training
The control group (B) will be provided an AFO to use on the paretic limb. This group will be instructed to walk on hard surfaces. This group group will be monitored daily using actigraphy and will receive weekly check-up telephone calls by a member of the research team to record number of steps, walking time, a scale for self-identified effort and perceived safety levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Walking Speed (Device Off)
Time Frame: 26 weeks
10 meter walk test (meters/second)
26 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg Balance Scale
Time Frame: 26 weeks
14 item objective measure designed to assess static balance and fall risk in adult populations. Items assessed include siting and standing balance during transfers, altered base of support, reaching, turning, eyes open and closed. Each item is scored 0 to 4 points for a maximum of 56 points.
26 weeks
6 Minute Walk Test
Time Frame: 26 weeks
The 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.
26 weeks
Stroke Impact Scale
Time Frame: 26 weeks
The SIS is a validated measure of the impact of stroke on overall physical and cognitive function. This 59-item patient-based questionnaire assesses eight domains of stroke recovery: strength, mobility, communication, emotion, memory and thinking, participation, activities of daily living/instrumental activities of daily living (ADL/IADL) and hand function. An additional question requires the patient to rate their stroke recovery on a scale from 0 to 100. This measure instructs subjects to answer the question based on the period of time twofour weeks prior to the questionnaire
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shirley Ryan AbilityLab

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, Santa Barbara

Investigators

  • Principal Investigator: Arun H Jayaraman, DPT, PhD, Shirley Ryan AbilityLab

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00219400
  • 1R01HD112475-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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