No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Shirley Ryan AbilityLab · Other
Who this trial is looking for
This trial is looking for people who have experienced foot drop after a stroke. Participants will use a special shoe to help improve their walking abilities at home while following an exercise program for six months.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have had a stroke at least 3 months ago.
I can walk at least 10 meters with or without help.
I can hear the clicking noise made by the shoe.
I am medically stable and have my doctor's approval.
I can understand and follow simple instructions.
I speak English.
I am willing to exercise with the shoe for 30 minutes most days.
You may not be able to join if
I have fallen more than once a week before my stroke.
I walk faster than 1.2 meters per second.
I have severe back pain or an untreated injury.
I am pregnant.
I have serious heart problems or seizures.
I have severe cognitive or communication issues.
I am in prison.
I am currently receiving Botox for my legs.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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-co…
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.
Trial Locations
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Status
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…
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.
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