Characterization and Clinical Trial of a Variable Friction Shoe
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShirley Ryan AbilityLab
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 3 months poststroke
Age 18 or older
Possess a prescribed AFO or be a potential candidate for use of an AFO
Can ambulate at least 10m with or without an assistive device such as a cane or walker
Disqualifiers
History of falling more than once a week prior to the stroke
Gait speed: self-selected velocity (SSV) greater than 1.2 m/s
Inability to operate in the devices safely and no caregiver assistance available
Morbid obesity (body mass index >40 kg/m2)
Trial design
Design model
Crossover
Treatments tested in this trial
Variable Friction Shoe Training
DeviceThe 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
DeviceThe 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Arm AB: Variable Friction Shoe Training, AFO TrainingExperimental treatment 2 interventions
Group B: Arm BA: Ankle Foot Orthosis (AFO) Training, Variable Friction Shoe TrainingExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Walking Speed (Device Off)
10 meter walk test (meters/second)
Time frame
26 weeksSecondary outcomes
1
Berg Balance Scale
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.
Time frame
26 weeks2
6 Minute Walk Test
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.
Time frame
26 weeks3
Stroke Impact Scale
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
Time frame
26 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shirley Ryan AbilityLab
Lead sponsor
University of California, Santa Barbara
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov