Characterization and Clinical Trial of a Variable Friction Shoe

NCT06234124 | Recruiting DMC

• 2 other identifiers: STU002194001R01HD112475-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Walking Speed (Device Off)

  10 meter walk test (meters/second)

  26 weeks

Secondary Outcomes (3)

• Berg Balance Scale

  26 weeks

• 6 Minute Walk Test

  26 weeks

• Stroke Impact Scale

  26 weeks

Study Arms (2)

Arm AB: Variable Friction Shoe Training, AFO Training

EXPERIMENTAL

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; Device: Ankle Foot Orthosis (AFO) Training

Arm BA: Ankle Foot Orthosis (AFO) Training, Variable Friction Shoe Training

EXPERIMENTAL

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; Device: Ankle Foot Orthosis (AFO) Training

Interventions

Variable Friction Shoe Training DEVICE

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.

Arm AB: Variable Friction Shoe Training, AFO Training; Arm BA: Ankle Foot Orthosis (AFO) Training, Variable Friction Shoe Training

Ankle Foot Orthosis (AFO) Training DEVICE

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.

Arm AB: Variable Friction Shoe Training, AFO Training; Arm BA: Ankle Foot Orthosis (AFO) Training, Variable Friction Shoe Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 3 months poststroke
• Age 18 or older
• Possess a prescribed AFO or be a potential candidate for use of an AFO
• Can ambulate at least 10m with or without an assistive device such as a cane or walker
• Medically stable as determined by physician medical clearance
• No expected change in medications for at least 3 months
• Adequate stability at the ankle during stance
• Ability to hear clicking noise made by the VF shoe
• Physician approval
• Ability to give informed consent
• Able to sit unsupported and be able to follow a three-step command
• No unhealed/unresolved orthopedic injury to either upper or lower extremity and no history of severe back pain
• English speaking
• 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)

You may not qualify if:

• History of falling more than once a week prior to the stroke
• Gait speed: self-selected velocity (SSV) greater than 1.2 m/s
• Inability to operate in the devices safely and no caregiver assistance available
• Morbid obesity (body mass index \>40 kg/m2)
• 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.
• Severe deficits in cognition or communication
• Pregnant women (status determined by self-reporting).
• Co-morbidity that interferes with the study (e.g. significant arthritis or joint problems, history of back injury, neuromuscular disorders, epilepsy, etc.).
• Severe Osteoporosis (status determined by self-reporting).
• Prisoners
• Not currently receiving botox to the lower extremities.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• University of California, Santa Barbara: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

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• Sakellaropoulos T, Vougas K, Narang S, Koinis F, Kotsinas A, Polyzos A, Moss TJ, Piha-Paul S, Zhou H, Kardala E, Damianidou E, Alexopoulos LG, Aifantis I, Townsend PA, Panayiotidis MI, Sfikakis P, Bartek J, Fitzgerald RC, Thanos D, Mills Shaw KR, Petty R, Tsirigos A, Gorgoulis VG. A Deep Learning Framework for Predicting Response to Therapy in Cancer. Cell Rep. 2019 Dec 10;29(11):3367-3373.e4. doi: 10.1016/j.celrep.2019.11.017.

  PMID: 31825821 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Arun H Jayaraman, DPT, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joe Harris, DPT

CONTACT

312-238-8425; jharris2@sralab.org

Jennifer Bartloff, DPT, PhD

CONTACT

312-238-1562; jbartloff@sralab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Trained study staff including licensed physical therapists
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Randomized controlled clinical trial with a crossover design

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 31, 2024
• Study Start: April 3, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)