Recruiting

Observational Study

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT06234124

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Variable Friction Shoe Training

Ankle Foot Orthosis (AFO) Training

Study Details

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.

Conditions

Stroke

Study ID

NCT06234124

Start date

Apr 3, 2024

Status verified date

May, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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)

experimental: 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)

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.

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.

Primary outcome measure

  • Walking Speed (Device Off) [ Time Frame: 26 weeks ]

Central Contacts and Locations

Central contacts

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

May 11, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2026-05-11.