Characterization and Clinical Trial of a Variable Friction Shoe

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Shirley Ryan AbilityLab
Study ID
NCT06234124
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Variable Friction Shoe Training — DEVICE
    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 — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Apr 3, 2024
Status verified
May 2026
Primary completion
Jan 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

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)

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Shirley Ryan AbilityLabChicagoIllinois60611
Joe H PT, DPT
[email protected]
312-238-8425
Sara Prokup, DPT
[email protected]
3122381355

Find similar trials in Chicago, IL

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Shirley Ryan AbilityLab· Chicago, IL

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