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RECRUITING
NCT06234124
NA

Characterization and Clinical Trial of a Variable Friction Shoe

Sponsor: Shirley Ryan AbilityLab

View on ClinicalTrials.gov

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.

Official title: Characterization and Clinical Trial of a Variable Friction Shoe, a New Paradigm of Reduced-constraint Locomotor Therapy for People Exhibiting Foot Drop Due to Stroke

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-04-03

Completion Date

2027-06

Last Updated

2024-11-25

Healthy Volunteers

No

Conditions

Interventions

DEVICE

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.

DEVICE

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.

Locations (1)

Shirley Ryan AbilityLab

Chicago, Illinois, United States