Clinical trial NCT06234124: Characterization and Clinical Trial of a Variable Friction Shoe
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: University of California, Santa Barbara
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-01-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized controlled clinical trial with a crossover design
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Walking Speed (Device Off)
timeFrame: 26 weeks
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: 26 weeks
measure: 6 Minute Walk Test
timeFrame: 26 weeks
measure: Stroke Impact Scale
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Arun H Jayaraman, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
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