Characterization and Clinical Trial of a Variable Friction Shoe

NCT ID: NCT06234124

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-03
• Study Completion Date: 2027-06-30

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.

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.

Exploratory Aim: Identify a systematic, methodical approach to device fitting, in-clinic and at-home training with the VF shoe and optimization of collecting outcome measures as assessments. For example, up to 10 participants will be enrolled for up to 8 visits over 12 weeks to determine the optimal data collection methods, fitting and training of use of VF shoes, and order of assessments, etc.

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

Variable Friction Shoe Training

Intervention Type: 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.

Ankle Foot Orthosis (AFO) Training

Intervention Type: 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 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)

Group Type: EXPERIMENTAL

Variable Friction Shoe Training

Intervention Type: 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.

Ankle Foot Orthosis (AFO) Training

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. At least 3 months poststroke

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

11. Not currently receiving botox to the lower extremities.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Santa Barbara

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Shirley Ryan AbilityLab

OTHER

Sponsor Role: lead

Responsible Party

Arun Jayaraman, PT, PhD

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arun H Jayaraman, DPT, PhD

Role: PRINCIPAL_INVESTIGATOR

Shirley Ryan AbilityLab

Locations

Shirley Ryan AbilityLab

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Joe Harris, DPT

Role: CONTACT

jharris2@sralab.org

312-238-8425

Jennifer Bartloff, DPT, PhD

Role: CONTACT

jbartloff@sralab.org

312-238-1562

Facility Contacts

Joe H PT, DPT

Role: primary

jharris2@sralab.org

312-238-8425

Sara Prokup, DPT

Role: backup

sprokup@sralab.org

3122381355

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Other Identifiers

1R01HD112475-01

Identifier Type: NIH

Identifier Source: secondary_id

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STU00219400

Identifier Type: -

Identifier Source: org_study_id