Stroke
Conditions
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.
Interventions
DEVICEVariable 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.
DEVICEAnkle 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.
Sponsors
Shirley Ryan AbilityLab
University of California, Santa Barbara
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Trained study staff including licensed physical therapists
Intervention model description
Randomized controlled clinical trial with a crossover design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking Speed (Device Off) | 26 weeks | 10 meter walk test (meters/second) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
Countries
United States
Contacts
CONTACTJoe Harris, DPT
CONTACTJennifer Bartloff, DPT, PhD
PRINCIPAL_INVESTIGATORArun H Jayaraman, DPT, PhD
Shirley Ryan AbilityLab
Outcome results
None listed