Characterization and Clinical Trial of a Variable Friction Shoe
- Conditions
- Stroke
- Interventions
- Device: Variable Friction Shoe TrainingDevice: Ankle Foot Orthosis (AFO) Training
- Registration Number
- NCT06234124
- Lead Sponsor
- Shirley Ryan AbilityLab
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm AB: Variable Friction Shoe Training, AFO Training Variable Friction Shoe 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) Arm BA: Ankle Foot Orthosis (AFO) Training, Variable Friction Shoe 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) Arm BA: Ankle Foot Orthosis (AFO) Training, Variable Friction Shoe Training Ankle Foot Orthosis (AFO) 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) Arm AB: Variable Friction Shoe Training, AFO Training Ankle Foot Orthosis (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)
- Primary Outcome Measures
Name Time Method Walking Speed (Device Off) 26 weeks 10 meter walk test (meters/second)
- Secondary Outcome Measures
Name Time Method Berg Balance Scale 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.
Stroke Impact Scale 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
6 Minute Walk Test 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.
Trial Locations
- Locations (1)
Shirley Ryan AbilityLab
🇺🇸Chicago, Illinois, United States